FDA

The article reviews FDA guidance documents released in the past 90 days and provides links to those guidance.

For anyone responsible for monitoring new and revised regulatory requirements, you should check the FDA website for new and revised guidance documents at least once every month. If you are not familiar with these FDA resources, here are the links for two of the FDA web pages:

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

Medical Device Academy will be updating this post weekly. We will also be updating training webinars and procedures associated with these guidance documents. The intent of this review is to help quality system auditors, quality managers, and other personnel responsible for regulatory affairs. It is difficult to stay current with the FDA regulations, and we are trying to make this easier.

New Final FDA Guidance Documents (Q3 2025)

There have been three new final FDA guidance documents released in Q3 2025:

1. Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions – Guidance for Industry and Food and Drug Administration Staff – August 22, 2025
2. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – Guidance for Industry and Food and Drug Administration Staff – August 18, 2025
3. Medical Device User Fee Small Business Qualification and Determination – Guidance for Industry, Food and Drug Administration Staff and Foreign Governments – July 30, 2025

New Draft FDA Guidance Documents (Q3 2025)

There have been no new draft FDA guidance documents released since January 2025 due to a shift in federal policy.

Animal Studies for Dental Bone Grafting Material Devices

This guidance is specific to dental bone grafting material devices. This guidance was originally issued as a draft on March 29, 2024. The devices included within the scope of the guidance are limited to the class II bone grafting material devices regulated under 21 CFR 872.3930 with the following product codes: LYC, NPM, and NUN.

Predetermined Changed Control Plan for AI-Enabled Device Software Functions

This guidance is specific to device software functions (i.e., SiMD or SaMD) that is enabled with artificial intelligence (AI). This guidance was originally issued December 4, 2024. The FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The guidance is intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.

Medical Device User Fee – Small Business Qualification and Determination

This guidance is specific to small businesses (i.e., companies with annual revenue of less than $100 million). The small business qualification must be renewed each year. Most small businesses we work with fail to submit the form early enough to take advantage of this deduction, or the companies have difficulty gathering the tax records required for the application. You can download the applicable forms and guidance from our website using the links provided below (Updated July 2025):

• Link to FDA Form 3602N for US Companies, Subsidiaries, Parent Companies, and Foreign Companies (New July 2025 Universal Form)
• Link to FDA July 2025 Guidance (updated guidance)

Medical Device Academy has a web page dedicated to this process and we can help you complete the application and submit it as a consulting service if needed.

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 web pages for the following four types of updates:

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

If you would like to receive email notifications where there are new or revised FDA guidance documents, please sign-up for our Lead Auditor Training course. Anyone that purchases the course will receive email notification of updates. They will also receive access to new and revised training to help them audit new and revised regulations as they are released.

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.

Medical device companies exporting devices into the USA must have a US agent to register, but what does an FDA US agent do?

What does an FDA US agent do?

Every medical device company outside the USA that distributes devices in the USA must have an FDA US agent. This includes manufacturers, contract manufacturers, and specifications developers outside the USA. The US agent assists the FDA in communication with the device company. The most common communications concern questions about devices exported to the US and scheduling FDA inspections. The role of the US agent is very similar to a European Authorized Representative, a UK Responsible Person, or a Swiss Authorised Representative. Unlike an EC Representative, you do not include US agents in your device labeling. The US agent’s name and contact information only appear on your FDA Establishment Registration record on the FDA website. 

Is there any certification or contract required for a US agent?

FDA US agents have no certification process, but you should have a formal signed agreement or contract with your agent. I have never seen the FDA request a copy of the contract or a letter from a US agent or the company that is registered. However, since the agent has a legal role and responsibility, you should ensure an agreement or contract is in place. The agreement or contract should include the following elements:

• Scope of service
• Commitment to perform US agent services promptly
• Duration of service (i.e., specific start and end dates)
• Termination provisions
• Consulting Fees for US agent services (typically an annual fee ranging from $250-$1,500)
• Any additional consulting fees if the FDA contacts your agent
• Who is responsible for payment of FDA User Fees ($11,423 for FY 2026 FDA User Fee)
• Commitment to communicating complaints, especially for potential risks to public health, serious injuries, or death, directly to your company
• Confidentiality clause or reference to a separate confidentiality agreement (Note: The agent may be compelled to disclose information they have to the FDA, but they should notify your company first if this happens.)
• Non-solicitation of your customers or suppliers and no solicitation of employees
• Force Majeure clause
• Identification of the agent’s name, address, phone, and email
• Identification of the company name, address, phone, DUNs Number
• Identification of the company contact’s name, title, address, phone, and email
• Identification of who will be the “Official Correspondent” in the FDA Registration Database
• Signature and Date

The US Agent is not required to be a legal entity, but you will need to enter a “Company Name.” There is no place to enter an EIN, and DUNS number is optional. Here’s a screen capture of the account creation form below.

You should also consider adding your agent to your Approved Supplier List (i.e., LST-003). If you do not already have a procedure for Supplier Quality Management (i.e., SYS-011), Medical Device Academy has a procedure available for purchase that includes a template for review and approval of new suppliers (i.e., FRM-005) and a template for an Approved Supplier List (i.e., LST-003). The FDA US agent doesn’t need a quality system, but they should be able to demonstrate competency in US FDA device regulations with their resume and/or training records. Specifically, competency should include 21 CFR 820, 803, 806, 830, and 807. In the future, your US agent must also be competent in ISO 13485:2016. FDA inspectors are expected to request evidence of an agreement between your company and the US agent. The inspector will also review your records for qualification, approval, and ongoing evaluation of the US agent as a supplier during FDA inspections. Ideally, your agent has been directly involved in previous FDA inspections, and they can prepare you by conducting a mock-FDA inspection.

What does the FDA do to qualify US agents?

The FDA does very little to qualify a US agent. The only thing the FDA “does” is to send an automated email to the FDA US agent when you submit your initial establishment registration or renew your FDA registration. The email subject line is “ACTION REQUIRED: U.S. Agent Assignment Notification.” The email is sent from “reglist@cdrh.fda.gov.” Your agent must ensure their email client has identified this email as a “safe sender” to prevent the email from ending up in a spam folder. For medical devices, there is no requirement for the US agent to submit any other proof to the FDA.

What is an “Action Required” email?

Below is an example of the “Action Required” email that the FDA sends to FDA US agents immediately after your registration and listing is completed by a foreign firm.

Your FDA US agent will receive an automated email from the FDA seconds after you complete your registration for an initial FDA establishment registration or the renewal of your FDA establishment registration. The agent then has ten (10) days to log in to their FURLS account and confirm that they are willing and able to serve as your company’s US agent. The email notifying your US agent includes the following language:

“If you are the U.S. Agent for this establishment, select “Yes”, and click “Submit”. If you are not the U.S. Agent for this establishment, select “No”, and click “Submit”. You must confirm you are the U.S. Agent within 10 business days. If you do not confirm that you are the U.S. Agent within 10 days, the system will automatically cancel your Receipt Code and remove the U.S. Agent information associated with the foreign establishment.”

Suppose the agent does not confirm their role within ten business days. In that case, the FDA will automatically email your company that the agent did not confirm their role. If you select a more reliable US agent, you must resubmit the request for the same person or a new person.

If you have additional questions or need a US agent, please contact Medical Device Academy.

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.