Maybe you need an FDA inspection plan. Does everyone in your company know what they need to do when FDA inspectors arrive at your facility?

Be proactive and don’t just let FDA inspections happen. You need to have an FDA inspection plan, and that plan needs to cover the roles and responsbilities for everyone. Below we have a list of 15 items that are in our FDA inspection work instruction (WI-009). If you already have a plan, try using the following checklist to assess your readiness for the next next inspection:

1. What will you ask and do when your FDA inspector calls the Friday before the inspection?
2. Who should be contacted by the FDA inspector if you are on vacation?
3. How will you communicate to the rest of your company that an FDA inspection is planned for Monday morning?
4. Who will greet the FDA inspector upon arrival, and what should they do?
5. Which conference room will the FDA inspector spend most of their time in?
6. Who will be in the conference room with you and the FDA inspector?
7. How will you track document and records requests, and how will you communicate that information to others?
8. How will you retrieve documents and records requested by the FDA inspector?
9. Who will conduct a tour of the facility with the FDA inspector and how will the tour be managed?
10. When quality issues are identified, how will you respond?
11. What will you do for lunches during the inspection?
12. Who will attend the closing meeting with the FDA inspector?
13. Should you “promise to correct” 483 inspection observations identified by the FDA?
14. How and when will you repsond to the inspector with corrective action plans?
15. If your company is outside of the USA, what should you do differently to prepare?

What will you ask and do when your FDA inspector calls the Friday before the inspection?

Most people begin their FDA inspection plan with the arrival of the inspector. However, you should consider including earlier events in your plan. Such as closure of previous 483 inspection observations, scheduling of mock-FDA inspections in your annual audit schedule, and details of how to interact with the inspector when they contact you just before an inspection. Most inspections will be conducted by a single inspector, but occasionally inspectors will be training another inspector. In this situation you can count on them following the QSIT manual more carefully, and you are more likely to receive an FDA 483 inspection observation. In the worst-case scenario, the lead inspector will split up from the trainee, and they will “tag-team” your company. This is not proper FDA procedure, but you should be prepared for that possibility. Therefore, make sure you ask the inspector if they are going to be alone or with another inspector when you speak with them on the phone. You should also get their name and phone number. You may even want to consider reviewing FDAZilla Store for details about your FDA inspector’s past inspection 483s and warning letters. Immediately after the call with the inspector, you should reserve a conference room(s) for the inspection and cancel your other meetings for the week. You should also verify that the person that contacted you is really from the FDA. You can do this by looking up their contact information on the Health and Human Services Directory. Your inspector should have a phone number and email you can verify on that directory.

Who should be contacted by the FDA inspector if you are on vacation?

You should always have a back-up designated for speaking with FDA inspectors, handling MDR reporting, and initiating recalls when you are on vacation. These are critical tasks that require timely actions. You can’t expect inspectors, MDRs, or recalls to wait you to get back in the office. It doesn’t matter what the reason is. Weddings, funerals, and ski trips should not be rescheduled. You need a back-up, and often that person is the CEO or President of your company. Make sure you have a strong systems in place (i.e. an FDA inspection plan, an MDR procedure, and a recall procedure). Whomever is your back-up needs to be trained and ready for action. This is also the purpose of conducting a mock-FDA inspection, including examples of MDRs in your medical device reporting procedure, and conducting mock recalls. This ensures you and your back-up are trained effectively. 

How will you communicate to the rest of your company that an FDA inspection is planned for Monday morning?

Most companies have an emergeny call list as part of their business continuity planning, and after the past 18 months of living with a Covid-19 pandemic your firm should certainly have a business continuity plan. Your FDA inspection plan should leverage that process. Contact the same people and notify them of when the FDA inspector is coming. If you are unable to find a conference room available for the inspection (i.e. see below), then ask the manager(s) that reserved the designated room for FDA inspections to relocate to another conference room for the week. Make sure you tell them who the inspector will be, and you might even be able to provide a photo of the inspector (try seraching LinkedIn). Make sure that you remind everyone to smile, and to listen carefully to the question asked. Everyone should be trained to answer only the questions asked, and nobody should run and hide. There should also be no need to stop your operations just because an inspector is visiting. You might even include the name of the inspector on a “Welcome Board” if your company has one at the entryway or in public areas. The more an FDA inspection appears as “routine” the better your outcome will be.

Who will greet the FDA inspector upon arrival, and what should they do?

By the time an FDA inspector(s) actually arrives at your company, all of the managers in your company should already been notified of the inspection and a conference room should be reserved for the inspection. Therefore, when the person that is greeting people in the lobby comes to work on Monday morning, you (or their supervisor) need to communicate with them and make sure that they are prepared for arrival. There are four things that should be communicated:

1. the name of the inspector(s) that are arriving
2. the list of managers that should be notified when the inspector(s) arrives (possibly identical to the buisness continuity call list)
3. the conference room that is reserved for the inspection

If the person greeting the inspector(s) is also going to escort them to the conference room and help them get set-up, then they will need additional instructions. If that escorting inspectors to the conference room and helping them get set-up is delegated to a different person, then the following considerations should be included in that person’s instructions:

1. the location of bathrooms and emergency exit instructions in case of a fire
2. the information for wireless connectivity
3. recommendations for seating in the conference room based upon the expected participants (see below)

It is important that an escort for the inspectors is able to bring the inspector(s) to the conference room as quickly as possible. They should not be expected to wait more than a few minutes for an escort.

Does your FDA inspection plan identify a specific room for the inspector? Is there a back-up?

Some companies have a specific room that is designated for inspections and 3rd party certification audits. If your comapny can do that, it will be very helpful because it reduces the decision making that is required immediatley prior to the inspection. Having a specific room for the inspection also eliminates the need to tell everyone else in the company where the inspector will be. Instead the location of the inspection can be in the work instruction or written FDA inspection plan. You shouldn’t need a back-up plan if there is a specific room designated for an FDA inspection, but our firm has a client that will be hosting three notified body auditors simultaneouly for three days. In that situation, you might need more than one room. 

Does your FDA inspection plan have assigned seating?

You might think that it really doesn’t matter where people sit in a conference room, but you will probably want consider the layout of charging cords and the flow of interviewees requested by the inspector. In your conference room, you will need room for at least the following people:

1. the inspector(s)
2. the management representative (i.e. you)
3. a scribe
4. an interviewee

If there is an inspector and a trainee, you will probably want to seat them together to facilitate them working together. You as the Management Representative also need to be in the room, and it may help for you to sit next to the scribe to facilitate communication between you and to make it easier for them to hand you documents after the scribe logs the documents into their notes. The scribe should probably sit closest to the door, because they will be receiving documents, logs, and records that are brought to the room. You will also need one more seat next to you, and probaby accross from the inspector(s), for interviewees. This person will rotate as different processes are reviewed. I also recommend having a location in the middle of the table for an “in box” where documents, logs, and records for the inspector are placed after being logged in. A second location in the middle of the table can be used for a “discard pile” as you finish using your copy of each document, log, and record. You may refer back to these copies later. The “discard pile” should be 100% copies rather than originals. Originals should never be brought into the room with the inspector.

Who is the scribe in your FDA inspection plan?

The perfect scribe would know the quality system well and they would have the typing skills of a professional stenographer. You might have someone that is an executive assistant in your company or a paralegal that could do this job, but you might also have a document control specialist that fits this requirement. Some companies will even hire a temp for the duration of the inspection that has this type of skill, but a temp is unlikely to know the jargon and quality system requirements well. I have taken on the role of scribe many times for my clients, because I type fast and know their quality system. I also don’t want to interferre with the inspection process. As scribe I can answer questions and offer suggestions when appropriate, but most of my time is spent taking notes and communicating by instant messenger with company members that are outside of the inspection room.

You should seriously consider using an application such as Slack as a tool for communication during the inspection. Then anyone in your company that needs to know the status of the inspection can be provided access to the Slack channel for the inspection. This can also act as your record of requests from the inspector. It’s even possible for people on the Slack channel to share pictures of documents to confirm that they have identified the document being requested. You could even invite someone to speak remotely with the inspector via Slack with Zoom integration. All the scribe needs to do is share the Zoom app with a larger display in the same conference room so the inspector can see it too.

Does your FDA inspection plan include provisions for  document and record retrieval?

The most important part of document and record retrieval during an FDA inspection is to remember that inspectors should never receive the original document. Ideally, a copier would be located immediately outside of the conference room and three copies would be made of every document before it enters the inspection room. The originals can be stored next to the copier until someone has time to return them to the proper storage location. The three copies should all be stamped “uncontrolled documents” to differentiate them from the originals. When the three copies are brought into the room, they should be handed to the scribe. The scribe should log the time the copies were delivered in the Slack channel. Then the copies should be handed to you, the Management Representative. You should skim the document to make sure that the correct document was received. Then one copy would be given to the inspector and another copy would be made available to the interviewee. If only two copies are needed, the extra copy can be placed in the “discard pile.”  Even if your system is 100% electronic, I recommend printing copies for the inspection. The paper copies are easier for inspectors to review, and it eliminates the ability for the inspector to hunt around your electronic document system. In this situation, the scribe may do all of the printing.

Does your FDA inspection plan indicate who will conduct a tour of the facility with the FDA inspector and how will the tour be managed?

I’m surprised by the number of companies that don’t seem to have a map of their facility. Medical device manufacturing facilities should have two kinds of facility maps. One should identify where pest control monitoring stations are located, and the second should indicate your evacuation route to exit the building. All guests should be shown the evacuation route map, probably within the first 30 minutes of arrival. The second map will be requested by the inspector eventually if you conduct manufacturing at your facility. Therefore, it would be helpful to use one or both of these facility maps as a starting point for creating a map of the route that inspectors should be taken on during a tour. I prefer to start with where raw materials enter the facility, and then I follow the process flow of material until we reach finished goods storage and shipping. If you can do this without back-tracking multiple times, then that will probalby be the preferred route. The purpose of planning the route out in advance is to help estimate how long the tour will take, and to make sure there is consistency. If someone starts the tour, and then another person takes over the tour, the new person should be aware of what the next location is and what areas have not been observed yet. There may also be safety reasons for avoiding certain areas during a tour and asking the inspector to observe those areas from a distance. Welding processes, for example, often fall into this safety category.

When quality issues (i.e. FDA 483 inspection observations) are identified, is this covered by your FDA inspection plan?

Third party certificaton body auditors will typically make you aware of nonconformities as they are identified, but FDA inspectors often will hold off on identifying 483 inspection observations until the end of the inspection in a closing meeting. However, you can typically identify several areas that may result in a 483 inspection observation during the inspection. You and the manager of that area may want to consider initiating a draft CAPA plan for each of these quality issues before the closing meeting. This would give you an opportunity to demonstrate making immediate corrections and you might be able to get feedback from the inspector on your root cause analysis and corrective action plan before the closing meeting. Sometimes this will result in an inspector identifying low-risk quality issues verbally instead of writing them out on FDA Form 483. I find the best way to make sure CAPA plans are initiated early is to have a debrief each day after the inspector leaves. All of the managers involved in the inspection should participate, and the debrief can be done virtually or in person. Virtually may be necessary, because often managers need to leave work before the inspector ends for the day. You should consider including this in your FDA inspection plan as well.

Does your FDA inspection plan include plans for daily lunches?

If your facility is located outside the USA, skip this paragraph and go to the section below about companies located outside the USA. If your company is locagted inside the USA, you can be certain that the FDA inspector will not eat lunch at your facility. They will leave for lunch on their own, and then they will return after lunch. Therefore, you may not have control of the timing of a lunch break but you will have time to take one. Most managers use the lunch break as a time to catch-up on emails. However, I think it makes more sense to change your email settings to “out of office.” You can indicate that you are hosting an audit and you will answer questions as a batch that evening or then next morning. You might use the lunch break to take a walk and relax, you might have  short debrief meeting with other managers, and you might spend some time preparing documents, logs, and records that the inspector may have requested before they left. Most inspectors use this strategy of asking for a list of documents and records in advance. This is also a good strategy to learn as an internal auditor or supplier auditor. If you have a back-room team that is supporting you, don’t make them wait for a break. Have someone in your company take their lunch orders or arrange for a catered buffet lunch. This will keep your support team happy, and you should definitely remember to include lunch for the team and changing your email settings to “out of office” in your FDA inspection plan.

Does your FDA inspection plan state who will attend the closing meeting?

Most companies have every manager that was in the opening meeting attend the closing meeting. This is ok, but it is important for anyone that might need to initiate a CAPA to be present in the meeting so that they can ask the inspector for clarification if needed. Scheduling a closing meeting should be part of your FDA inpsection plan. However, the past 18 months of the Covid-19 pandemic has taught us that we can attend this type of meeting remotely via Zoom. Therefore, we recommend letting the managers go home early if they are no longer needed as auditees. Instead, ask them to call in for a Zoom meeting at the time the FDA inspector estimates for review of the 483 inspection observations with the company.

Should you “promise to correct” 483 inspection observations identified by the FDA?

During the closing meeting the FDA inspector will review 483 inspection observations with you and any of the other managers present at the closing meeting. The inspector will ask if you promise to correct the 483 inspection observations that were identified. You should confirm that you will, and the FDA inspector will add this to the Annotations in the Observations section of FDA Form 483 that you will recive at the closing meeting. By stating this, you are agreeing to create a corrective action plan for each of the 483 inspection observations. You could change you mind later, but the better approach is to perform a thorough investigation of the 483 inspection observation first. If you determine that corrective action is not required, you can explain this in your CAPA plan and provide data to support it. The only likely reason for not correcting an observation is that you determined the incorrect information was provided to the inspector. In that case, you may need to do some retraining or organize your records better as a corrective action to prevent recurrence in a future inspection. You might even make modifications to your work instruction for “Conducting an FDA Inspection” (i.e. FDA inspection plan).

How and when will you repsond to the inspector with corrective action plans?

Your FDA inspection plan should include details on how respond to FDA 483 inspection observations and when the response must be submitted by. The FDA inspector will give you instructions for submission of your corrective action plans by email to the applicable email address for your region of the country. This email address and contact information should be added to your work instruction as an update after the first inspection if you are not sure in advance. You should respond with a copy of your CAPAs with 15 business days. Regardless of what the inspector told you, there is always a possibility that the outcome of your inspection could be “Official Action Indicated.” This is because the inspector’s supervisor makes the final decision on whether a Warning Letter will be issued and regarding the approval of the final inspection report. You should also confirm what the 15-day deadline is, because your state’s holidays may be different from the US Federal holidays.

If your company is outside of the USA, what should you do differently to prepare?

The US FDA only has jurisdiction over companies that are located in the USA. Therefore, if your company is registered with the FDA, you can only be inspected if you agree to host the FDA inspector when they contact you. FDA inspectors will contact foreign firms 6-8 weeks in advance, and they will typically give you a couple of weeks to choose from. After you confirm the dates for the inspection, then they will make their travel plans. Therefore, you will know exactly when the FDA inspection is schedulea and you will have more than month to prepare. Therefore, you should do four things differently:

1. You should send the FDA inspector directions from the airport to your facility and provide recommendations for potential hotels to stay at. Ideally the hotels you recommend will provide transportation from the airport and managers that are speak passable English). The hotels should be appropriate for business travel–not royalty. If it is convenient, you may even offer to pick-up the inspector at the hotel each day to ensure they have no problems with local transportation.
2. You should offer to provide lunches for the inspector during the inspection. This should not be considered entertainment. The purpose is make sure the inspector has lunch (i.e. a light meal or snacks) and drinks (i.e. water and coffee) during the inspection so that they do not have to negotiate local traffic, struggle with ordering food in a language they don’t know, and to eliminate delays associate with having lunch off-site. Make sure you remember to ask about food allergies and dietary restrictions. You might even follow-up with a draft menu to obtain confirmation that your proposed menu is appropriate.
3. You should schedule a mock-FDA inspection immediately to verify that everyone is prepared and to identify any CAPAs that need to initiated before the FDA inspector finds the problems.
4. During the first day of the inspection, you may consider asking the inspector if they would like to go out for dinner one of the evenings with a couple of people from your company or if they would like any recommendations for restaurants to eat at. If you are not familiar with US customs and international travel, ask the hotel concierge for advice. When you are out to dinner, the conversation should remain professional and if you normally drink alcohol at dinner you may want to consider the “BOB” compaign in the Netherlands as a role model. 

How are you going to train everyone in your company?

You need an easy way to train everyone in your company. Why not give them a video to watch? Next Monday, July 26, 2021 @ Noon EDT, we are hosting a webinar on how to prepare for an FDA inspection. It is a live webinar where you will be able to ask questions, and we are bundling the webinar with our new work instruction for “Conducting an FDA Inspection” (WI-009). If you register for the webinar, you will receive access to the live webinar, you will receive the native slide deck, and you will receive a copy of the work instruction. You can use the work instruction as an FDA inspection plan template for your company. The webinar will be recorded for anyone that is unable to attend the live session. You will be sent a link to download the recording to watch it as many times as you wish, and we recommend that you use the webinar as training for the rest of your company.

If you have a surprise FDA inspector visit, you should never be scared because there is no difference between the best and worst-case outcome.

Why are you scared of an FDA inspector?

There are a number of reasons why you might be scared of an FDA inspector, but if you keep reading you will learn why 95% of your fear is self-induced. A small percentage of device manufacturers evaluate the performance of quality managers based on the outcome of FDA inspections, but you have no control over whom the FDA Office of Regulatory Affairs (ORA) assigns to perform your inspection. If your company belongs to this 5% minority, you need to change top management’s approach to regulators or you need to find a new employer. For the majority of us, we are scared of embarrassment, failure, or being “shut down.”

There are rare examples of where the FDA has taken action to stop the distribution of medical devices, but this is only done as a last resort. Usually, companies cooperate with the FDA with the hope of being able to resolve quality issues and resume distribution after corrective actions are implemented. Not only is this type of action rare, but there will be a prior visit to your facility and prior written communication from ORA before you receive a warning letter–let alone removal of your company’s device(s) from the market. You can’t pass or fail an FDA inspection. The FDA inspector is verifying compliance with the FDA Quality System Regulation (i.e. 21 CFR 820) as well as the requirements for medical device reporting (i.e. 21 CFR 803), reports of corrections and removals (i.e. 21 CFR 806), investigational device exemptions (i.e. 21 CFR 812), and unique device identification (UDI). FDA inspectors only have time to sample your records, and with any sampling plan, there is always uncertainty. When you do receive an FDA 483 inspection observation you should not consider it to be a condemnation of your company. Likewise, an absence of 483 observations is not a reason to celebrate.

Why you should not be embarrassed when you receive a 483 from an FDA inspector

The most irrational response to an FDA 483 inspection observation is embarrassment. Our firm specializes in helping start-up medical device companies get their first product to market. This includes providing training and helping them to implement a quality system. When our clients have their first FDA inspection, it is not uncommon to receive an FDA Form 483 inspection observation. Start-ups have limited resources and limited experience, and most of the employees have never participated in an FDA inspection before. Experience matters and immature quality systems have only a limited number of records to sample. Any mistakes are easy for an inspector to find.

Instead of feeling embarrassed, acknowledge and embrace your inexperience. For example, during the opening meeting with an FDA inspector, you might say, “We are a new company, and this is our first FDA inspection. I am also a first-time quality manager. If you find anything that we are doing incorrectly, please let us know and we will make immediate corrections and start working on our CAPA plan.” You can say this with a smile :), and you can genuinely mean what you said because it’s true.

Anticipation is always worse than reality

Another reason you are scared of an FDA inspection is that you don’t know exactly when the inspection will be. Only Class III PMA devices, and a few Class II De Novo devices with novel manufacturing processes, require a pre-approval inspection. For the rest of the Class II devices, ORA prioritizes inspections based on risk. There are a few companies prioritized for inspection within the first six months of your initial FDA registration, such as reprocessors of single-use devices and contract sterilizers. For the rest of the Class II device manufacturers, your first inspection should be approximately two years after your company registers with the FDA. If you are located outside the USA (OUS), your first inspection might take three years to schedule. Finally, Class I device manufacturers and contract manufacturers, are unlikely to ever be inspected by the FDA. If you didn’t know what the typical timeline was for ORA to schedule your first inspection, you probably just breathed a HUGE sigh of relief when you read this paragraph.

Even if you already know the approximate timeline and priorities for FDA inspections, it’s normal to feel a little anxiety when the date of your first visit is unknown. Your boss and the rest of the top management are probably feeling just as much anxiety as you are, or even more if they have no idea what the timeline and priorities are. You should make sure that everyone in your company understands what they are supposed to do during an FDA inspection, and if you forget to tell them you might cause a lot of unneeded drama when they find out an FDA inspector is in the front lobby. Preparing for an FDA inspection is no different from conducting a fire drill. Everyone should know the procedure, and you should practice (i.e. conduct a mock FDA inspection). Practice ensures that everyone knows what to do during the first 30 minutes of an FDA inspection, and nobody in your company will panic when an FDA inspector actually arrives.

Let’s define “surprise” visits by an FDA inspector

A surprise visit from an FDA inspector is extremely rare, but in the USA inspectors will call on Friday to confirm that your company will be open the following Monday for an inspection. The FDA has jurisdiction over medical device manufacturers located in the USA, and they are not required to give advanced notice. However, inspectors need time to prepare in advance for their inspection–just like an ISO 13485 auditor. Therefore, before an inspector arrives on-site for a routine (Level 2) inspection, the inspector will first make a courtesy call to the official correspondent identified in your establishment registration.

What happens when an FDA inspector travels outside the USA

In the case of OUS medical device manufacturers, the FDA inspector does not have jurisdiction. Therefore, they will contact the official correspondent 6-8 weeks in advance to schedule an inspection. Inspectors will typically make contact via email, and you may be given a couple of weeks to choose from for the FDA inspection. The duration of your inspection should be 4.5 days. The inspector will arrive on Sunday, and the inspection will begin on Monday morning. The inspector has four major process areas to cover, and Friday morning will be focused on generating a preliminary report of 483 inspection observations. The reason why you can predict this OUS routine with a degree of certainty is two-fold: 1) these are government workers following a procedure, and 2) the FDA inspector needs time to get to the airport for their flight home.

What is the outcome of an FDA inspection?

FDA inspections have three possible outcomes:

1. No action indicated – there were no FDA 483 inspection observations identified by the FDA inspector
2. Voluntary action indicated – there was at least one FDA 483 inspection observation identified by the FDA inspector, and the FDA inspector requests submission of a CAPA plan to prevent recurrence
3. Official action indicated – there was at least one FDA 483 inspection observation identified by the FDA inspector, and the FDA inspector requires submission of a CAPA plan to prevent recurrence; if a plan is not received in 15 business days, a warning letter will automatically be generated on the 16 day

Even in the rare instances with there is “no action indicated” (i.e. best case scenario), I have always noticed one or more things during an FDA inspection that were overlooked and we needed to initiate a new corrective action plan(s). In the other two possible scenarios, the FDA inspector identified the need for one or more corrective action plans. Therefore, regardless of whether your FDA inspection results in the best-case scenario or the worst-case, you will always need to initiate a new corrective action plan(s).

If the outcome is always a CAPA, what should you do?

Give your FDA inspector a big smile and say, “We are a new company, and this is our first FDA inspection. I am also a first-time quality manager. If you find anything that we are doing incorrectly, please let us know and we will make immediate corrections and start working on our CAPA plan.” Making sure that you have a genuine smile is just as important as what you say. Smiling will relax you and the anxiety and stress you are feeling will gradually melt away. Smiling will encourage the FDA inspector to trust you. Maybe your smile will even be contagious.

If you need help responding to an FDA 483 inspection observation, or you want to conduct a mock-FDA inspection, please use our calendly app to schedule a call with a member of our team. We are also hosting a live webinar on FDA inspections on July 26, 2021 @ Noon EDT.

About the Author

Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

This article explains the FDA regulations related to private labeled devices that are already 510k cleared and distributors want to import.

This article was initially inspired by a question asked on the Medical Devices Group website hosted by Joe Hage. Companies often ask about how to private labeled devices in the USA, because they are unable to find anywhere in the FDA regulations where private labeling of the device is described. The reason for this is because the FDA regulations for devices allow for the labeling to identify the distributor only—without any mention of the OEM manufacturer on the label. In contrast, most other countries have “own-brand labeling” regulations or regulations for private labeling devices. It is also important to remember that the FDA only approves devices through the pre-market approval (PMA) pathway. All other devices fall into one of three categories: 1) 510k exempt, 2) 510k cleared, or 3) De Novo classification request approved. Devices that fall into the third category will subsequently fall into category 1 or 2 after the FDA approves the classification request.

Questions about the private labeled devices process for FDA

Our distribution company is interested in getting a private labeled devices agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance, and the only product change will be the company’s name and address on the label. There will be no change to the indications for use. Please answer the following questions:

1. Is it legal to eliminate all mention of the OEM from the device labeling?
2. Who is responsible for complaint handling and medical device reporting? OEM or private-labeled distributor?
3. What is the process to get this private label for the Class II device?
4. How can our distribution company avoid paying the FDA user fee?

Answer to the first question about private labeled devices

The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. Therefore, if Joe Hage were the distributor, and you were the manufacturer, there are two legal options for the private labeled device: 1) “Distributed by Joe Hage”, or 2) “Manufactured for Joe Hage.”

The manufacturer is not required to be identified on the label. However, the OEM must be registered and listed with the FDA. If the OEM is outside the USA, then the distributor must register and list with the FDA as the initial importer and reference the K number when they complete the FDA listing. There is no approval required by the FDA. You will need a quality agreement defining the roles and responsibilities of each party, but that is all.

Answer to the second question about private labeled devices

The quality agreement must specify which company is responsible for complaint handling (21 CFR 820.198) and medical device reporting (21 CFR 803). In this situation, the OEM is the specification developer, as defined by the FDA. Therefore, the OEM will be responsible for reporting and execution of recalls. Therefore, even if the distributor with a private label agreement is identified as the “complaint file establishment,” the OEM will still need to obtain copies of the complaint information from the distributor, and determine if medical device reporting and/or corrections and removals are required (i.e., recalls).

Answer to the third question about private labeled devices

There is no formal process for “getting a private label.” The entire private label process is negotiated between the distributor and the OEM with no involvement of the FDA. However, in the listing of devices within the FDA FURLS database, all brand names of the device must be identified. Therefore, the OEM will need to add the new brand name used by the distributor to their listing for the 510(k) cleared product. However, the FDA does have the option to keep this information confidential by merely checking a box in the device listing form.

Answer to the fourth question about private labeled devices

If the distribution company is the initial importer of a device into the USA, then the distributor must be registered with the US FDA as the initial importer, and the distributor will need to pay the FDA user fee for the establishment registration. That user fee is $5,236 for FY 2020, and there is no small business discount for this fee. The only way to avoid paying the user fee is to have another company import the device, who is already registered with the FDA, and to distribute the product for that company. I imagine some logistics brokers might be acting as an initial importer for multiple distributors to help them avoid paying the annual FDA user fee for establishments. That company might also be providing US Agent services for multiple OEMs. However, I have not found a company doing this.

Is private labeling of device legal in the USA?

The FDA is unique in that they allow either the distributor or the manufacturer to be identified on the label, but both are not required. Therefore, if Joe Hage were the distributor, and you were the manufacturer, there are two legal options for the private label: 1) “Distributed by Joe Hage”, or 2) “Manufactured for Joe Hage.”

Who must register, list, and pay user fees for medical devices?

This question is frequently asked, and the table with the information was not visible on my mobile browser. Therefore, I copied the table from the FDA website and posted the information in the image below. The information is copied directly from the FDA website:

Registration and Listing Requirements for Domestic Establishments

Registration and Listing Requirements for Foreign Establishments

For products that are manufactured outside the USA, and imported into the USA, the initial importer is often the company identified on the label. There are two typical private labeling situations, but other possibilities exist:

1. If the initial importer owns the 510(k), then the manufacturer outside the USA is identified as the “contract manufacturer,” and the initial importer is identified as the “specifications developer.” Both companies must register their establishments with the FDA, and there needs to be a quality agreement between the two companies defining roles and responsibilities. The contract manufacturer outside the USA is not automatically exempt from reporting requirements and complaint handling. The contract manufacturer outside the USA may decide to label the product as a) “Manufactured by”, b) “Manufactured for”, or c) “Distributed by.” Options “a”, “b” and “c” would list the importer’s name because they own the 510(k), and they are the distributor. This situation often occurs when companies outside the USA want to sell a product in the USA, but they do not want to take on the responsibility of obtaining 510(k) clearance. These firms often believe this will exempt them from FDA inspections, but the FDA is increasingly conducting FDA inspections of contract manufacturers due to this private label situation.
2. If the manufacturer owns the 510(k), then the manufacturer outside the USA is identified as the “specifications developer” and the “manufacturer,” while the initial importer will be identified as the “initial importer.” The importer may also be specified as the complaint file establishment and/or repackager/relabeler in the FDA registration database. The manufacturer outside the USA will not be able to import the device into the USA without identifying an initial importer in the USA in the FDA FURLS database. The manufacturer outside the USA may decide to label the product as a) “Manufactured by”, b) “Manufactured for”, or c) “Distributed by.” Options “b” and “c” would list the importer’s name, while option “a” would list the manufacturer’s name. This situation often occurs when US companies want to be the distributor for a product made outside the USA, and the company wants a private labeled product. This also happens when the OEM wants the option to have multiple US distributors.

In both of the above private-label situations, the non-US firm must have a US Agent identified because the company is located outside the USA. The US Agent may be the initial importer, but this is not required. It could also be a consulting service that acts as your US Agent. The US Agent will be responsible for receiving communications from the FDA and confirming their role as US agents each year when the registration is renewed. Medical Device Academy offers this service to non-US clients we help obtain 510(k) clearance.

Follow-up questions

A Korean company, with a US distribution subsidiary, would like to private label a medical device with an existing 510(k) owned by another company in their name. Does the Korean company need a contract in place before private labeling? Does the US subsidiary and/or the Korean parent company need to be registered in the USA prior distribution of the private-labeled version of the device in the USA?

Rob’s response: Initially, it was unclear from the wording of the question as to whom is the 510(k) owner, which company will be on the label, who is doing the labeling, and who is doing the importing to the USA. The person asking Joe Hage this question tried clarifying their question via email, but we quickly switched to scheduling a phone call using my calendly link. I have reworded the question above, but here are some of the important details I learned during our phone call:

1. The person asking was already acting as the relabeler, repackager, and they were distributing the product in the USA. This person’s company is also registered with the FDA.
2. The device is 510(k) cleared by another US company, and there is no need to worry about the complications of an initial importer being identified for a product manufactured in the USA.

In this situation, the relabeler/repackager can relabel the product for the Korean company’s US subsidiary as long as there is a quality agreement in place for all three parties (i.e., relabeler, distributor, and manufacturer). There is no need for the Korean parent company to register with the FDA. There is no need for a new 510(k) submission, and the US subsidiary does not need to register with the FDA—as long as the quality agreement specifies that the US subsidiary will maintain records of distribution, facilitate recalls if required, and notify the manufacturer of any potential complaints and/or adverse events immediately. The manufacturer with 510(k) clearance will be responsible for complaint handling, medical device reporting, and execution of recalls according to the agreement. The relabeler will be responsible for maintaining records of each lot of product that is relabeled for the US subsidiary, and the relabeler must maintain distribution records that link the original manufacturer’s lot to the lot marked on the relabeled product.

If you have questions about the private labeling of your device, please contact us.

The article reviews FDA guidance documents released in the past few months, including the new Final FDA guidance on biocompatibility, published June 16.

For anyone responsible for monitoring new and revised regulatory requirements, the FDA guidance documents are something you probably check at least once every month. If you are not familiar with these FDA resources, here are the links for two of the medical device FDA guidance documents webpages:

• Recent Medical Device Final FDA Guidance Documents
• Recent Medical Device Draft FDA Guidance Documents

New Final FDA Guidance Documents

The last time I reviewed an FDA guidance document was in February for the new guidance document from the FDA related to usability engineering and human factors engineering. There was a new final FDA guidance document released by the office of device evaluation on June 16: “Use of ISO 10993-1”.This biocompatibility guidance was expected for release in December, but the release was delayed.

Use of ISO 10993-1

The new biocompatibility guidance that was published last month provides specific guidance about the application of certain tests required for demonstrating biocompatibility. For example, test article preparation and risk assessments for the applicability of specific tests is addressed. A revised test matrix is included in the guidance document. Special considerations are provided for each of the following biocompatiblity tests:

• cytotoxicity,
• sensitization,
• hemocompatibility,
• pyrogenicity,
• implantation,
• genotoxicity,
• carcinogenicity,
• reproductive and developmental toxicity, and
• degradation assessments

New Final Rule for Symbology

In addition to FDA guidance documents, the FDA also released a final rule on symbology that will modify 21 CFR Parts 600, 801, and 809. The FDA is finally changing its position on the acceptance of harmonized symbols in place of English text. The FDA is accepting ISO 15223-1 as a recognized standard and allowing manufacturers to use the symbols instead of English text to facilitate global harmonization of labeling. The FDA is only allowing the use of Rx-Only as to indicate that a product is a prescription only. The guidance even defines the acceptable process for creating new product-specific pictograms. The effective date of the new final rule will be September 13, 2016. 

New Draft FDA Guidance Documents

In addition to final FDA guidance documents, there have been several new draft guidance documents that were released recently:

1. List of Highest Priority Devices for Human Factors Review
2. Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)
3. Characterization of UHMWPE for Orthopedic Devices
4. Technical Considerations for Devices for Additive Manufacturing

The second two FDA guidance documents focus on materials that are important for orthopedic manufacturers because UHMWPE is used as a wear surface for join implants, and many of the implants and instruments are now being manufactured using additive manufacturing instead of forging, casting or milling bar stock.

How to keep up on FDA Regulation Changes

If you are interested in keeping up on new and revised regulations from the FDA, I wrote a blog explaining four ways to identify new and updated FDA regulations. The blog identifies FDA webpages for the following four types of updates:

1. Guidance Documents
2. Recognized Consensus Standards
3. Device Classifications
4. Total Product Lifecycle (TPLC) Database

The ISO 15223-1 standard for medical device symbols has been released for several years, but the FDA did not recognize it until June 14, 2016. The recognition of the Standard is part of the implementation process for the new final rule regarding the use of symbology for medical device labeling. The timing of this new final rule coincides with the implementation of UDI labeling requirements for Class II devices. Also, the new European Medical Device Regulations now specify labeling requirements for the primary sterile packaging as part of the Essential Requirement (ER) 19.2:

• (a) an indication permitting the sterile packaging to be recognized as such,
• (b) a declaration that the device is in a sterile condition,
• (c) the method of sterilization,
• (d) the name and address  of the manufacturer,
• (e) a description of the device,
• (f) if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
• (g) if the device is custom-made, the words’ custom-made device’,
• (h) the month and year of manufacture,
• (i) an indication of the time limit for using or implanting the device safely,
• (j) an instruction to check the Instructions For Use for what to do if the sterile packaging is damaged etc.

These new requirements will require many manufacturers to redesign labeling for sterile packaging, and the ability to use symbology will assist in creating globally harmonized labeling.

This article presents a Pareto Analysis of FDA 483 inspection observations from FY 2015. It compares the trends observed with a similar Pareto analysis that was performed a couple of years ago on FY 2013 data.

Method of Data Analysis for FDA 483 Inspection Observations

The FDA posts Excel spreadsheets on the website to download data for FDA 483 Inspection Observations. These spreadsheets include inspection results for all the divisions of the FDA. To perform data analysis for FY 2015 results, I deleted the sheets that were not specific to medical device manufacturer inspections (i.e., only used data from CDRH). I sorted the data by the regulation that was referenced. For example, all the sub-clauses for 21 CFR 803 were combined into one category for the Pareto analysis. The combined categories were then sorted from the most frequent 483 inspection observations to the least frequent 483 inspection observations. The data was then added to the graph that I produced in February 2014 using FY 2013 results as a second data set. The resulting graph is shown above.

Comparison of FDA 483 Inspection Observations between FY 2013 and FY 2015

For MDR Compliance (i.e., 21 CFR 803), there was a slight increase in the number of 483 observations issued from FY 2013 to FY 2015. However, the difference was only a 1% increase from 6.2% to 7.2% of the total number of 483s issued. There was an even smaller increase in the number of findings related to purchasing controls (i.e., 5.6% increased to 6.1%). I noticed a slight drop in the number of findings related to design controls, CAPA, and complaint handling. However, the overall trend for FY 2013 and FY 2015 is essentially the same.

There are two other categories where an increase was observed: 1) process validation increased by 0.7% from 4.8% to 5.5%, and 2) control of nonconforming product increased 0.8% from 4.3% to 5.1%. These areas are important. Control of nonconforming product is one of the major sources of CAPAs and often results in design changes. Therefore, FDA inspectors are reviewing your data for a nonconforming product during inspections to help them identify potential CAPAs and design changes that may have been made. The typical sequence is 1) nonconformity, 2) investigate nonconformity as part of a CAPA, and 3) initiate a design change as a corrective action.

Process validation is a completely different area that is separate from CAPA, complaint handling, and MDRs. However, inadequate process validation is a common root cause of nonconformities. Therefore, inspectors often follow an audit trail from a nonconforming product record back to a process change that was implemented but inadequately validated. Thus, an increased focus on nonconformities may be the reason for an increase in FDA 483 inspection observations related to process validation.

So what’s the big deal?

This proves that the FDA inspectors continue to be predictable. The “playbook” for FDA inspections is the QSIT Manual. It hasn’t changed since 1996. Yet, companies continue to be shocked and amazed by FDA inspectors.

Additional Resources

If you want to learn how to prepare for FDA inspections, I recorded a webinar you can download (FREE). I recorded the webinar in May of 2014, but it’s been a couple of years, and I’ve learned a few new tricks. Therefore, I’m going to re-record the webinar and update it for lessons learned. I’ll even share a few tools and approaches to avoid findings and reduce the risk of warning letters. I’m also evaluating a new application that is designed for teams to have private chats and file sharing during an inspection. Stay tuned to my webinars page, and I’ll post that webinar soon. Maybe I’ll record something from Germany next month.

Until then, I am working on a webinar specific to medical device reporting. Many companies have still not updated their MDR procedures to reflect the eMDR process using electronic submissions gateways. Therefore, I’m releasing an updated procedure for MDRs, and I am offering a webinar bundle to train people on how to comply with 21 CFR 803 and the procedure. You might also be interested in my previous webinar specific to control of the nonconforming product.

Article explains how to determine which FDA Form 483 response you should write a corrective action plan for first and why.

In a perfect world, you would not receive any inspection observations from your next FDA inspection. However, most companies get at least one observation resulting from an FDA inspection and often there are multiple observations on an FDA Form 483. If you

Most Common FDA 483 inspection observation

Companies that have not experienced an FDA inspection before worry too much and prepare too little. Inspections are predictable and certain inspection observations are much more common than others. A couple of years ago I wrote an article analyzing the most common FDA inspection observations. The most common observations are specific to design controls (i.e., 21 CFR 820.30). However, this fact is distorted because many companies receive multiple observations during the same inspection related to design controls. For example, a client of mine recently received three from one inspector: 1) lack of design reviews, 2) lack of design validation, and 3) lack of risk analysis. All three were found during the review of the same design history file and the one corrective action addresses all three observations.

how to determine which FDA Form 483 response you should write a corrective action plan for first

2nd Most Common FDA 483 inspection observation

The second most common observation is specific to corrective and preventive actions (i.e., 21 CFR 820.100). Typically the company has inadequate procedures for verifying and validating effectiveness of corrective actions taken. If this is one of your FDA 483 observations, then you may have a problem with CAPA training or with the design of your CAPA form. If there is no place on the CAPA form to document your effectiveness check, then you might easily forget to perform the verification and validation of effectiveness. Another possibility is that personnel are confused between verification of implementation and the verification of effectiveness.

What if you have multiple FDA 483 observations?

Other common FDA 483 observations include medical device reporting, complaint handling and rework of nonconforming product. If you receive more than one FDA 483 inspection observation, you need to assume there is a chance that the inspection outcome will be “Official Action Indicated” (OAI). In this case, you need to provide a 483 response to your FDA district office within 15 business days. With such a short time to prepare your 483 response, you need to be efficient. Which 483 response should you initiate first and why?

If one of the inspection observations is related to the CAPA process, that 483 response should be your top priority. The reason for this is that the FDA will want to see objective evidence of implementing corrective actions whenever possible. If you use your CAPA procedure and form to document the 483 response, then you can show the FDA how the revised procedure or form will be used in your 483 response. If you write your 483 response for other inspection observations first, then the other 483 responses are using the existing procedure or form that the identified as inadequate.

Your first step should always be to implement corrective actions to address an inadequate CAPA process by revising the procedure or the form. Once the procedure or form is updated, then you can use the new process to document the rest of your 483 responses.

Training Webinar for an FDA 483 response

If you need help preparing an FDA 483 response, click here for our webinar explaining the 7 steps for responding to an FDA Form 483 inspection observation. You can also download a CAPA procedure and CAPA form from our SOP page.

In 2016, the FDA released a final FDA Human Factors Guidance that explains the requirements for human factors testing of medical devices.

FDA Human Factors Guidance

The FDA released a final guidance document on the subject of “Applying Human Factors and Usability Engineering to Medical Devices.” This is a final guidance document that replaces the previous version that was released in 2000 and the draft that was released in 2011. The diagram below is Figure 3 from this new FDA guidance, and it includes references to sections 5 through 9 of the guidance document.