How to request FDA Device Classification information – 513(g) Alternative

This blog provides a five-step process on how to request FDA device classification information. A screenshot of the FDA website for each step is included.

If your company is currently registering with the US FDA, you are probably reviewing the guidance document this month for the FY2013 user fees. On pages six and seven, there is a table of these fees, but you might have overlooked 513(g). Section 513(g) is a provision in the law that allows companies to request device classification information from the FDA.

For example, if your company was developing a new product, and you were having difficulty identifying the regulatory pathway, 513(g) is your friend. In my opinion, these fees are modest: $5,061 = Standard Fee, and $2,530 = Small Business Fee (updated for FY 2022). Most consultants will charge at least ten hours of consulting to identify the regulatory pathway for a company. I would charge quite a bit less because it takes me a lot less than ten hours. I still think the FDA’s pricing is a good deal because getting information directly from the source is always more valuable than an “expert.”

The US FDA has published a guidance document explaining the process for 513(g) requests. This guidance document was released on April 6, 2012 (updated in 2019). The guidance explains what information companies need to provide in order to submit a 513(g) request. The guidance also has a fantastic list of FDA resources on page five. These are the very same resources that the “experts” use—including yours truly.

Just as any good lawyer tries to avoid asking questions that they don’t already know the answer to, I recommend that you first try using these resources yourself. Once you think you know the answer, your request for classification information will be easier to organize.

Here’s how I would proceed to request FDA device classification information: 

Step 1 – Are there similar devices on the market?

Identify another device similar to yours. If you can’t do this, you need serious help. You need a similar device that is already sold on the market to use as a predicate device. If you cannot identify a predicate, then you can’t use the 510(k) process—or you don’t know your competition. Either way, there are challenges to overcome. For example, if you are trying to launch a new topical adhesive made from cyanoacrylate—”Dermabond” might be the first predicate device that comes to mind.

registration and listing How to request FDA Device Classification information   513(g) Alternative

Step 2 – Search the Registration Database for FDA Device Classification

Use the registration and listing database on the FDA website to find the company that manufacturers the device. The link for this is #4 on my helpful links page (updated). This link also will provide you with connections to the classification database—which you can use to find the classification for any device. However, the registration and listing database is less likely to lead you astray. When I type “Dermabond” into the field for the proprietary device name, I get a list of five different product listings.

5 listings for dermabond How to request FDA Device Classification information   513(g) Alternative

Step 3 – Select one of the competitor links to identify the FDA Device Classification

Clicking on any one of these five will take you to a listing page for the corresponding company. On that page, you will find the three-letter product code that identifies the device classification and the applicable regulations for that device.

device listing for dermabond1 How to request FDA Device Classification information   513(g) Alternative

Step 4 – Your found the FDA Device Classification

Clicking on the three-letter product code (i.e., – “MPN” in our Dermabond example) takes you to the Product Classification page. This is where you will find that Dermabond, and other tissue adhesives, are Class II devices that require a 510(k) submission. Also, the Product Classification page identifies an applicable guidance document to follow for design verification and validation testing. This is also called the “Special Controls Document.”

mpn product classification How to request FDA Device Classification information   513(g) Alternative

Step 5 – TheTPLC Report lists all the recent 510(k) submissions

Click on the “TPLC Product Code Report” link. This link will provide you with a report of all the 510(k) ‘s recently granted to your competitors, problems customers have experienced with their products, and recalls for the past five years. This is extremely valuable information as a design input—as well as competitive information for your marketing team.

tplc total product life cycle report for mpn How to request FDA Device Classification information   513(g) Alternative
TPLC Report for Product Code “MPN” – Topical Adhesive

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10 FDA Inspection Strategies that DON’T Work

If you were just notified of an FDA inspection and you don’t think you are ready, using tricks to hide your problems is a huge mistake. I have heard a few recommendations over the years for “secrets” to hide those problems. In this post, I share my favorite “secrets”–and why they DON’T work.

Here are my top 10 ways to make an FDA inspection worse:

10. Stalling when the investigator makes a request – This just irritates investigators. At best, the investigator will use the waiting time to identify additional documents to sample or to review the information you have provided more closely. At worst, the investigator will accuse the company of not cooperating with the inspection, and the investigator may return the following week with several more team members to help them. Whenever this occurred during a third-party audit that I conducted, I would move onto another area and interview someone. However, before I left the person that was slow to respond, I provided the person with a list of documents and records that I expected to be waiting for me upon my return. In extreme cases, I had to bluntly tell the management representative that I needed documentation more quickly. As an instructor, I teach auditors techniques for coping with this tactic.

9. Suggesting records for the investigator to sample – This is specifically forbidden in the case of third-party inspections and audits. The FDA has work instructions for identifying sample sizes, and samples are supposed to be selected randomly. In reality, samples are rarely random, and usually, the investigator is following a trail to a specific lot, part number, etc. When clients offered me samples, I tried to be polite and review the record they provided. However, I also would request several other records or follow a trail, as I have indicated above. Another approach I often use is to focus on high-risk items (i.e., – a risk-based approach to sampling). In general, you can expect the FDA investigators to sample more items than a registrar–and sample sizes are often statistically derived if the number of records is sufficiently large. When sample sizes are quite small, I recommend sampling 100% of the records since the previous inspection/audit. This is not always possible for third-party auditors, but internal auditors often can achieve this.

8. Outsourcing processes to subcontractorsThe FDA recently reinstated the requirement for contract manufacturers and contract sterilizers to be registered with the FDA by October 1, 2012. Therefore, hiding manufacturing problems from the FDA by outsourcing manufacturing is increasingly more difficult to do. In addition, the FDA focuses heavily on supplier controls and validation of outsourced processes. Therefore, an investigator will identify high-risk processes performed by subcontractors and request documentation of process validation by that supplier. If the company does not have the validation reports, this could quickly escalate to a 483, and possibly a visit to the subcontractor.

7. Trying to correct problems during the inspection – This is what I like to call the document creation department. At one company I worked for, we noticed a mistake across several of the procedures and made a change overnight between the first and second days of the audit. When the auditor asked for the procedures in the morning, he asked, “Is the ink dry yet?” The auditor then proceeded to request records that demonstrated compliance with the newly minted procedures. As you might have guessed, this resulted in several nonconformities. When clients attempt to correct problems found by an investigator, the investigator typically will respond with the following statement, “I applaud you for taking immediate action to contain and correct the problem. However, you still need to perform an investigation of the root cause and develop a corrective action plan to prevent a recurrence. To do this investigation properly may take several days.” I also teach auditors to memorize this phrase.

6. Writing a letter to file – When companies make minor design changes, one of the most common approaches is to “write a letter to file.” This phrase indicates that the design team is adding a memo to the Design History File (DHF) that justifies why design validation is not required or why regulatory notification/approval is not required. The FDA used to publish a decision tree to help companies make these decisions. In fact, such a decision tree is still part of the Canadian significant change document. The FDA recently withdrew a draft document that eliminated many perceived opportunities to utilize the “letter to file” approach. However, the FDA will still issue a 483 to a company if the investigator can identify a change that required validation that was not done, or a 510(k) that was not submitted for a design change. In fact, the FDA looks explicitly for these types of issues when an investigator is doing a “for cause” inspection after a recall or patient death.

5. Shut it down – Not running a production line that has problems is an ideal strategy for hiding problems. However, the FDA and auditors will simply be forced to spend more time sampling and reviewing records of the problematic production line. If you need to shut a line down, ensure everything is identified as nonconforming, and carefully segregate rejected product from good product. You should also use these problem lines as an opportunity to show off your investigation skills and your ability to initiate CAPAs. If you simply forgot to validate a piece of equipment, or do some maintenance, take your lumps and keep production running. If you are a contract manufacturer, never shut it down without notifying the customer. If you do not tell your customer, you will get a complaint related to on-time delivery and a 483.

4. Storing all records off-site – I first heard about this tactic during an auditor course I was co-teaching. During the course, we had many reasons why the company should be able to provide the records in a timely manner. However, I have experienced this first-hand as a third-party auditor. When this happens, I do three things: 1) increase my sampling of records that are available, 2) carefully review supplier controls and supplier evaluation of the storage facility (assuming it is outsourced), and 3) verify that the company has a systematic means for tracking the location (i.e., – pallet and box) for every record sent to storage. FDA investigators will simply move along to another record and follow-up on their earlier request with a second visit, or a request to send a copy of the document to them after the inspection.

3. Identifying information as confidential – A company can claim information is confidential and may not be shared with the public. Still, very little information is “confidential” concerning the FDA or Notified Bodies. Therefore, this strategy rarely works. In fact, this will enrage most FDA investigators. In training courses, I train auditors to ask the auditee to redact confidential information. For example, a CAPA log may have confidential information in the descriptions, but the trend data on opening and closing dates are never confidential.

2. The FDA is not allowed to look at those records – Although this statement is technically true for internal audit reports and management reviews, the FDA always says that they can access this information through the CAPA system. What the FDA means is that there should always be evidence of CAPAs from internal audits and management reviews. If there is not, then this will quickly become a 483. Another person I met tells the story that when they agreed to share the management review records with the investigator, the inspector rarely issued a 483. When they refused to share the management review with the FDA, the inspection went quite badly from that point forth. I don’t agree with being vindictive, but it happens.

1. Show me where that is required – This is just silly. Investigators and auditors are trained on the regulations, while you are educated on your procedures. Spend your time and effort, figuring out how your procedures meet the regulations in some way. Challenging the investigator excites the investigator. We all like a challenge–and we rarely lose. One auditee tried this approach with me in front of their CEO. This experience allowed me to show off that I had memorized the clause in question–and the corresponding guidance document sections. I think the CEO realized quickly that the management representative was not qualified.

My final advice is to do your best to help the investigator do their job, and treat every 483 as “just an opportunity to improve.” Just ensure you submit a response in 14 days, or you will receive a Warning Letter too!

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Wiki Document Control

The author read an article about wiki document control and he shares a “genius idea that is coming of age.”

Wiki Document Control

Procedures can always be improved, but our goal is to make better products—not better procedures. So what could possibly be so exciting about document control that I feel compelled to write another post about “blah, blah, blah?” I read an article about using Wiki for document control. A Wiki is just a collaborative environment where anyone can add, delete, and edit content. All changes are saved, and Wiki can be controlled—while simultaneously being available to everyone. The most famous of all Wiki is Wikipedia. In 2009, Francisco Castaño (a.k.a. – Pancho) began a discussion thread to explain how his company was using a Wiki to manage their documentation system. In the last month, ASQ published an update on the status of Pancho’s Wiki process for document control. Depending upon how you implement a Wiki and what software tools you use, it might be a virtual quality system or an eQMS.

Writing Procedures

In most companies, the process owner writes procedures, and other people in the company rarely comment on minor errors. In the most dysfunctional companies, the Quality Department writes the procedures for the rest of the company or outsources them to consultants. Reviewing and editing procedures should be the responsibility of everyone in the company. Still, I never considered the possibility of having everyone within the company edit procedures simultaneously—until I saw Pancho’s thread. Throughout the discussion, others have indicated that they also tried using Wiki to optimize content. This is a genius idea that is coming of age.

Many QMS consultants, including myself, have written procedures for clients. Sometimes this is part of the consulting business model. In these cases, the consultant writes a procedure once and edits it forever—while getting paid a modest fee each time a client asks for a “new” procedure. I often think that it would make more sense to do something like Linux developers have done—use the collaboration of QMS experts around the world to create a general procedure that is free to everyone. This is possible using Wiki’s that are publicly available.

Very soon (hopefully in 2013), the responsibilities section of our procedures will fundamentally change. Instead of reading and understanding, everyone will be responsible for writing and editing (oh no, I’ll have to create a new learning pyramid).

Quality will no longer be responsible for writing procedures. Instead, the quality function can focus on monitoring, measuring, data analysis, and improvement of processes and products. The downside is that we will need fewer personnel in document control.

If you want to learn more about Wiki for document control, follow this thread I found on Elsmar Cove. It’s rich in content, and even the moderators have been forced to rethink their preconceptions.

You should also read two articles by Pancho:

  1. Using a Wiki for Document Control
  2. Using a Wiki to Implement a Quality Management System

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Do you need to purchase the latest EN ISO 14971 version?

It is not necessary to purchase the EN ISO 14971 version because you should already be compliant and amendments are sold separately.

Discussion about a risk management standard 1024x664 Do you need to purchase the latest EN ISO 14971 version?

If the above conversation sounds familiar, hopefully, this blog will help.

Note: This is a 2012 blog that will be updated and/or consolidated soon, but here’s a link for risk management training.

Question 1: What is the current version of EN ISO 14971?

Answer 1: EN 14971 was revised to 2012 on July 6, 2012. The previous 2009 version was withdrawn. The ISO version is not changing–just the EN version.

Question 2: What’s new in 2012?

Answer 2: Only the three Annexes related to harmonization with the three directives (MDD, AIMDD, and IVDD) were updated. The content of the Standard itself has not changed.

Question 3: Do I need to buy EN ISO 14971… which really hasn’t changed since 2007?

Answer 3:  No…unless you still have the 2000 version. (just my personal opinion … not anyone else necessarily agrees)

Why you don’t need to buy the  EN ISO 14971 version…

Historically, Annex ZA was the annex at the back of a Standard that would explain how it is harmonized with the European Directives. However, in 2009, Annex ZA was separated into ZA, ZB, and ZC. Each of these Annexes explained how the current version of ISO 14971  (then ISO 14971:2007) differs from each of the three directives. In addition, there was a correction to Figure 1 (i.e., – arrow in the wrong location). Neville Clarke provided a good summary of these minor changes that occurred in 2009. The European Commission was concerned with some of the differences between the 2009 Standard and the Directives. Therefore, the Standard has been updated to clarify these differences.

There are seven technical deviations from the Standard that are required for compliance with the European Directives. Marcelo Antunes is an expert on Standards, and he accurately describes these deviations as “weird” in a discussion thread on Elsmar Cove’s Forum. The deviation that seems to have caught the most attention is the requirement to reduce ALL risk to “as low as possible” (ALAP) rather than to a level that to “as low as reasonably practicable” (ALARP concept). The “ALAP” acronym was a joke, but it wouldn’t be the first time that something like this stuck (i.e., – SWAG).

An alternative approach to verifying compliance with EN ISO 14971

If you sleep with a label maker under your pillow, you should buy the new BS EN 14971:2012 version,  so you can ensure that you are staying in compliance with each of these seven deviations and that you have considered the implications fully in your procedure for Risk Management. However, if you are a practical person that prefers not to upset the entire development team, I recommend a different approach.

1. Download a copy of the relevant Directive from the Europa Website

2. Using Adobe, search the entire Directive for the word “risk”:

AIMDD = 24 times

MDD = 55 times

IVDD = 34 times

3. Systematically review where the word “risk” is used to determine if you need to make adjustments for your CE Marked products. If you already have a CE Mark, there should be no changes required to your risk management documents. Your procedures might need clarification to observe the requirements of the Directive when there is a difference between the Standard and the Directive.

Last Question: What is your Notified Body auditor going to do?

Final Answer: I’m not sure, because every auditor is a little different in their approach. However, as an instructor, I would teach an auditor to ask open-ended questions, such as: “How did you determine if there is an impact upon your procedures and design documentation with regard to the updated Standard?” (i.e., – impact analysis). If the company provides an impact analysis and explains why the existing risk documentation and procedure should not change, I believe this meets the requirements for “equivalency with the State of the Art.”

Honestly, I haven’t seen one single company that was 100% in compliance with the “letter” of the Directives or the Standard. Sometimes, rational thought must overcome political compromises and irrational behaviors.

On the other hand, it’s always possible that these seven deviations, and the information on corrective action, will fundamentally change the way your company approaches risk management (I just dare you to bring it up in your next management review).

If you would like a second opinion, the Document Center’s Standard Forum says, “As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO 14971 is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.” FYI…Document Center’s Standard Forum sells Standards. You can buy this one from them for $324.

 

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Auditing Design Controls – 7 Step Process

This blog reviews seven steps for effectively auditing design controls utilizing the ISO 13485 standard and process approach to auditing.

turtle diagram for design controls Auditing Design Controls   7 Step Process

Third-party auditors (i.e., – a Notified Body Auditor) don’t always practice what we preach. I know this may come as a huge shock to everyone, but sometimes we don’t use the process approach. Auditing design controls is a good example of my own failure to follow was it true and pure. Instead, I use NB-MED 2.5.1/rec 5 as a checklist, and I sample Technical Files to identify any weaknesses. The reason I do this is that I want to provide as much value to the auditing client as possible without falling behind in my audit schedule.

Often, I would sample a new Technical File for a new product family that had not been sampled by the Technical Reviewer yet. My reason for doing this is that I could often find elements that are missing from the Technical File before the Technical Reviewer saw the file. This gives the client an opportunity to fix the deficiency before submission and potentially shortens the approval process. Since NB-MED documents are guidance documents, I could not write the client up for a nonconformity, unless they were missing a required element of the M5 version of the MDD (93/42/EEC as modified by 2007/47/EC). This is skirting the edge of consulting for a third- party reviewer, but I found it was a 100% objective way to review Technical Files. I also found I could review an entire Technical File in about an hour.

What’s wrong with this approach to auditing design controls?

This approach only tells you if the elements of a Technical File are present, but it doesn’t evaluate the design process. Therefore, I supplemented my element approach with a process audit of the design change process by picking a few recent design changes that I felt were high-risk issues. During the process audit of the design change process, I sampled the review of risk management documentation, any associated process validation documentation, and the actual design change approval records. If I had time, I looked for the following types of changes: 1) vendor change, 2) specification change, and 3) process change. By doing this, I covered the following clauses in ISO 13485:2016: 7.4 (purchasing), 7.3.9 (design changes), 7.5.6 (process validation), 7.1 (risk management), and 4.2.5 (control of records).

So what is my bastardized process approach to auditing design controls missing? Clauses 7.3.1 through 7.3.10 of ISO 13485:2016 are missing. These clauses are the core of the design and development process. To address this, I would like to suggest the following process approach:

Step 1 – Define the Design Process

Identify the process owner and interview them. Do this in their office–not in the conference room. Get your answers for steps 2-7 directly from them. Ask lots of open-ended questions to prevent “yes/no” responses.

Step 2 – Process Inputs

Identify how design projects are initiated. Look for a record of a meeting where various design projects were vetted and approved for internal funding. These are inputs into the design process. There should be evidence of customer focus, and some examples of corrective actions taken based upon complaints or service trend analysis.

Step 3 – Process Outputs

Identify where Design History Files (DHF) are stored physically or electronically, and determine how the DHF is updated as the design projects progress.

Step 4 – What Resources

This is typically the step of a process audit where their auditor needs to identify “what resources” are used in the process. However, only companies that have software systems for design controls have resources dedicated to Design and Development. I have indicated this in the “Turtle Diagram” presented above.

Step 5 – With Whom, Auditing Training Records

Identify which people are assigned to the design team for a design project. Sometimes companies assign great teams. In this case, the auditor should focus on the team members that must review and approve design inputs (see Clause 7.3.2) and design outputs (see Clause 7.3.3). All of these team members should have training records for Design Control procedures and Risk Management procedures.

Step 6 – Auditing Design Controls Procedures and Forms

Identify the design control procedures and forms. Do not read and review these procedures. Auditors never have the time to do this. Instead, ask the process owner to identify specific procedures or clauses within procedures where clauses in the ISO Standard are addressed. If the process owner knows exactly where to find what you are looking for, they’re training was effective, or they may have written the procedure(s). If the process owner has trouble locating the clauses you are requesting, spend more time sampling training records.

Step 7 – Process Metrics

Ask the process owner to identify some metrics or quality objectives they are using to monitor and improve the design and development process. This is a struggle for many process owners–not just design. If any metrics are not performing up to expectations, there should be evidence of actions being taken to address this. If no metrics are being tracked by the process owner, you might review schedule compliance.

Many design projects are behind schedule, and therefore this is an important metric for most companies. Now that you have completed your “Turtle Diagram,” if you have more time to audit the design process, you can interview team members to review their role in the design process. You could also sample-specific Technical Files as I indicated above. If you are performing a thorough internal audit, I recommend doing both. To learn more about using the process approach to auditing, you can register for our webinar on the topic.

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Auditing Medical Device Software Vendors

This blog presents some thoughts related to auditing medical device software companies.

Software medical devices are used to assist medical professionals. For example, radiologists use software with identifying areas of interest for medical imaging. Do you know how to audit a software company?

As a third-party auditor, I have had the pleasure of auditing software companies for CE Marking. When you audit a software company for the first time, this forces you to re-learn the entire ISO 13485 Standard. For example, if a company only produces software (i.e. software as a medical device or SaMD) there is very little to sample for incoming inspection and purchasing records. This is because the product is not physical—it’s software. Clauses of ISO 13485 related to sterility, implants, and servicing are also not applicable to software products. If the software is web-based, the shipping and distribution clauses (i.e., – 7.5.5) might present a challenge to an auditor as well.

The aspects of the ISO 13485 Standard that I found to be the most important to auditing software products were design controls and customer communication. Many auditors are trained in auditing the design and development of software, but very few auditors have experience auditing technical support call centers. When auditing a call center, most of the calls represent potential complaints related to software “bugs,” system incompatibilities with the operating system or hardware, and use errors resulting from the design of the user interface.

In most technical support call centers, the support person tries to find a work-around for problems that are identified. The problem with a “work-around” is that it is the opposite approach to the CAPA process. To meet ISO 13485 requirements, software companies must show evidence of monitoring and measuring these “bugs.” There must also be evidence of management identifying negative trends and implementing corrective actions when appropriate.

As an auditor, you should focus on how the company prioritizes “bugs” for corrective actions. Most software companies focus on the severity of software operations and the probability of occurrence. This is the wrong approach. Failure to operate is not the most severe result of medical device software failure. Medical device software can result in injury or death to patients. Therefore, it is critical to use a risk-based approach to the prioritization of CAPAs. This risk-based approach should focus on the severity of effects upon patients—not users. This focus on safety and performance is emphasized throughout the EU Medical Device Regulations and it is a risk management requirement in ISO 14971.

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What is an NB-MED?

The author defines what an NB-MED is, Team NB and their role, provide a regulatory update and some information sources.

Each time I review a list of external standards, I notice at least a few references that are out-of-date. Occasionally, I am surprised, and everything appears to be current, but it is almost impossible to stay current with all the external standards. The most demanding standards to maintain are those that are untracked. Untracked standards are difficult to keep current with because it requires manually checking each source to determine if a standard has been updated. One of these sources is Team NB.

Team NB

Team NB describes itself as the “European Association of Notified Bodies for Medical Devices.” Team NB is an organization comprised of Notified Bodies (NBs). These NBs create guidance documents to clarify the interpretation of regulations in the EU. Since NBs are generating the documents, rather than Competent Authorities (CAs), it is possible for Team NB to reach a consensus more quickly than CAs. Since these documents are guidance documents, the NB-MED documents are not enforceable or binding. However, in all likelihood, your NB will interpret ISO 13485 and the MDD (93/42/EEC as modified by 2007/47/EC) in accordance with these guidance documents.

The website link I provide in my “Helpful Links” page includes many links to important guidance documents. Among the recently updated NB-MED documents is NB-MED 2.5.2/rec 2. The “rec” is not the same as a revision. For example, rec two is “Reporting of design changes and changes of the quality system,” while rec 1 is “Subcontracting – QS related.” The link I have provided will land you directly on the list of NB-MED documents, and the right-hand column identifies the date the document was added to the list. Therefore, if you want to know about new and revised NB-MED documents, you merely need to read the documents that are identified as being added since your last visit.

NB-MED 2.4.2/rec 2

At this time, NB-MED 2.5.2/rec 2 is the only recent addition—and you should read it. Many companies struggle with design changes, and they don’t know if the change is significant or not. Revision 8 of this document includes helpful examples. I recommend reading this document carefully and then revising your own change notification procedure to match the document. If you don’t have a change notification procedure, your QMS auditor has been lazy. Don’t let them give you the excuse of “It’s just a sampling.” This document has been published for a long time, and the intent has not changed since 2008—just new examples to clarify the interpretations.

There is a posting from 1/14/11. This is an excellent list of all the NB-MED documents. I recommend printing this document and using it to compare against your current external standards list. There is a very recent posting from 2/7/12 that answers frequently asked questions about the implementation of EN 60601. If you don’t know what this is, you probably don’t have an active device.

On 3/27/12, there was a letter from Team NB indicating that they condemn Poly Implant Prothèse (PIP) for committing fraud (well duh). Who would endorse them?

Finally, on April 17, 2012, meeting minutes were posted from an April 5 meeting of Team NB. The NBs indicated that the medical device authorization system is excellent! This is not a surprise since any other response would be self-criticism and potentially career-limiting. The minutes also indicate that the Team wants as many of the members to endorse the “Code of Conduct” (CoC) that was recently drafted by the “Big 5” NBs. So far, the acceptance of this Code is limited, but the Competent Authorities have other plans.

Competent Authorities (CAs) are currently evaluating the NBs with regard to competency for handling Class III devices. In addition, there is a plan to revise the regulations in Europe (2014 is the guess). These changes will be major. The Team NB website could be a source of information about rapid changes in the next 12 months, but for now, it’s the quiet before the storm. The Great Consolidation of European Regulators is about to begin (or maybe all the NBs will endorse the CoC, and the CAs will forget about it).

 

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Process Approach to Auditing – 7 Steps to Training Auditors

The process approach to auditing is demonstrated using Turtle Diagrams as a tool instead of using traditional auditor checklists.

tutle diagram1 Process Approach to Auditing   7 Steps to Training Auditors

I have been reviewing trends for how people find my website, and a large number of you appear to be interested in my auditing schedules and other audit-related topics. Therefore, this week’s blog is dedicated to training auditors on the process approach.

First, the process approach is just a different way of organizing audits. Instead of auditing by clause, or by procedure, instead, you audit each process. Typical processes include:
  1. Design & Development
  2. Purchasing
  3. Incoming inspection
  4. Assembly
  5. Final Inspection
  6. Packaging
  7. Sterilization
  8. Customer Service
  9. Shipping
  10. Management Review
  11. CAPA
  12. Internal Auditing

Why the Process Approach is Recommended

First, the process approach identifies linkages between processes as inputs and outputs. Therefore, if there is a problem with communication between departments, the process approach will expose it. If only a procedural audit is performed, the lack of communication to the next process is often overlooked.

Second, the process approach is a more efficient way to cover all the clauses of the ISO Standard than auditing each clause (i.e.,– the element approach). My rationale for the claim of greater efficiency is simple: there are 19 required procedures in the ISO 13485 Standard, but there are only 12 processes identified above. The “missing” procedures are incorporated into each process audit.

For example, each process audit requires a review of records as input and outputs. Also, training records should be sampled for each employee interviewed during an audit. Finally, nonconforming materials can be identified and sampled at incoming inspection, in assembly processes, during final inspection, during packaging, and even during shipment. The tool that BSI uses to teach the process approach is the “Turtle Diagram.” The diagram above illustrates where the name came from.

Interviewing with the Process Approach

The first skill to teach a new auditor is the interview. Each process approach audit should begin with an interview of the process owner. The process owner and the name of the process are typically documented in the center of the turtle diagram. Next, most auditors will ask, “Do you have a procedure for ‘x process’?” This is a weak auditing technique because it is a “closed-ended” or yes/no. This type of question does little to help the auditor gather objective evidence. Therefore, I prefer to start with the question, “Could you please describe the process?” This should give you a general overview of the process if you are unfamiliar with it.

After getting a general overview, I like to ask the question: “How do you know how to start the process.” For example, inspectors know that there is material for incoming inspection because raw materials are in the quarantine area. I have seen visual systems, electronic and paper-based systems for notifying QC inspectors of product to inspect. If there is a record indicating that material needs to be inspected—that is the ideal scenario. A follow-up question is, “What are the outputs of the inspection process?” Once again, the auditor should be looking for paperwork. Sampling these records and other supporting records is how the process approach addresses Clause 4.2.4—control of records.

The next step of this approach is to “determine what resources are used by incoming inspection.” This includes gauges used for measurement, cleanliness of the work environment, etc. This portion of the process approach is where an auditor can review calibration, gowning procedures, and software validation. After “With What Resources,” the auditor then needs to identify all the incoming inspectors on all shifts. From this list, the auditor should select people to interview and follow-up with a request for training records.

The sixth step is to request procedures and forms. Many auditors believe that they need to read the procedure. However, if a company has long procedures, this could potentially waste valuable time. Instead, I like to ask the inspector to show me where I can find various regulatory requirements in the procedures. This approach has the added benefit of forcing the inspector to demonstrate they are trained in the procedures—a more effective assessment of competency than reviewing a training record.

Challenging Process Owners

The seventh and final step of the turtle diagram seems to challenge process owners the most. This is where the auditor should be looking for department Quality Objectives and assessing if the department objectives are linked with company quality objectives. Manufacturing often measures first pass yield and reject rates, but every process can be measured. If the process owner doesn’t measure performance, how does the process owner know that all the required work is getting done? The seventh step also is where the auditor can sample and review the monitoring and measurement of processes, and the trend analysis can be verified to be input into the CAPA process.

In my brief description of the process approach, I used the incoming inspection process. I typically choose this process for training new auditors because it is a process that is quite similar in almost every company, and it is easy to understand. More importantly, however, the incoming inspection process does an effective job of covering more clauses of the Standard than most audits. Therefore, new auditors get an appreciation for how almost all the clauses can be addressed in one process audit. If you are interested in learning more about Turtle Diagrams and the process approach to auditing, please register for our webinar on the process approach to auditing.

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Canadian Medical Device Regulations (CMDR): Identifying New Changes

The author reviews a few methods to identify changes to the Canadian Medical Device Regulations (CMDR), including using the “compare” function in MS Word.

One of the most frustrating things about the Canadian Medical Device Regulations (CMDR), SOR/98-282, is the difficulty in identifying what has changed since the previous revision. There is no detailed revision history indicating what changed. This is surprising to me because Canada was the first country to require ISO 13485 certification as a component of the regulatory approval process. Did the Therapeutic Products Directorate (TPD) overlook Clause 4.2.3?

Using MS Word to Compare CMDR Versions

Anyway, before I became an auditor, the way I determined what changed was to use the “compare” function in MS Word to compare the versions of the CMDR. The bottom of the first page indicates, “Current to May 14, 2012.” This is our revision date, and it seems to change every month. Then below this, the document says, “Last amended on December 16, 2011.” This tells us that the last time TPD made a change was in December. Nowhere does CMDR tell us what changed.

On the second page of the CMDR, there is a note at the bottom of the page that supposedly clarifies the revision history:

“This consolidation is current to May 14, 2012. The last amendments came into force on December 16, 2011. Any amendments that were not in force as of May 14, 2012, are set out at the end of this document under the heading ‘Amendments Not in Force’.”

I have never seen a heading titled “Amendments Not in Force.” So here’s what I do:

  1. “Select All” from the current PDF version of the CMDR and another version before the last amendment date: December 16, 2011.
  2. I copy and paste the text from each document into a separate MS Word document.
  3. I save each document with a different date code.
  4. I use the “compare” function to identify the revisions that were made to the pre-December version.
  5. Then I pound my forehead against my desk because I just wasted 15 minutes to verify that the only changes made between August 8, 2011, and May 14, 2012, were as follows:
    • Date of revision throughout the document
    • Table of Provisions pagination was updated to reflect reformatting of Annex 3
    • Section 32.7 – changed wording from “may” to “shall,” and “giving” to “that gave”
    • Annex 3 was reformatted so that the English and French versions appear side-by-side instead of on page 61 & 62 sequentially

Assessing the Impact of Change

So…the next time a third-party auditor asks you for objective evidence that you have assessed the impact of changes to the CMDR, show them this blog posting. If they force you to document the impact analysis of the change of the word “may” to the word “shall” in Section 32.7, request a new auditor quickly. If they ask for documentation of the impact of the tense change in Section 32.7, also request a new auditor quickly.

On a far less amusing note, the following new and revised regulatory requirements occurred on the TPD website:

  1. On May 31, 2012, there was an announcement by HC indicating “Categorization of Therapeutic Products at the Device/Drug Interface.”
  2. On October 19, 2011, the electronic submission pilot for Class IV devices was expanded to Class III devices: “Notice – Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application”; this revised guidance document includes a table for Class III applications based upon the STED guidance document from GHTF.

You can also type in “What’s New” into the search engine for the TPD website. The search results can be narrowed down to a year, and postings are typically no more frequent than monthly (eight in 2011; one in 2012).

You should also be aware of the third-party auditor report guidance document (GD211):Guidance on the Content of Quality Management System audit reports. This was released on June 8, 2011. You can also get training on this GD211 format at the US FDA website. The webinars are at the bottom of the list. 

If you are interested in learning more about the CMDR or CMDCAS, please join my LinkedIn CMDCAS Group.

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FDA Approval Process: “Triage” for 510(k)

The Triage program for 510(k) submissions is reviewed. The goal of this FDA approval process program is to reduce review time from 90 to 30 days.

Thursday, Congress voted 96 to 1 for a bill to increase FDA user fees. The rationale is that the FDA needs more funding to be strong enough to properly regulate foods, drugs, and medical devices. One of the commitments linked with this new funding is to shorten the review of 510(k) submissions. To this end, OIVD has created a new program called “Triage.” The goal of this program is to accelerate the review of specific traditional 510(k) submissions to 30 days instead of 90 days.

In theory, this pilot program will help some companies get their 510(k) clearance letter faster, but simultaneously, the FDA will be able to concentrate resources on high-risk 510(k) submissions. This entire strategy seems to be the opposite of triage. Triage involves sorting sick patients into three categories:

1) Those who are likely to live, regardless of what care they receive

2) Those who are likely to die, regardless of what care they receive

3) Those for whom immediate care might make a positive difference in their outcome

If we apply the triage analogy to 510(k) submissions, we see three categories:

1)      510(k) submissions that are likely to be approved, regardless of how much time the FDA spends

2)      510(k) submissions that are likely to be rejected, regardless of how much time the FDA spends

3)      510(k) submissions whose approval or rejection is not apparent, but the FDA’s earlier involvement in the design and development process would substantially improve review time.

The FDA’s “triage” program is intended to demonstrate improvement in the time required to approve medical devices by sorting submissions into two groups: group #1 above and group # 2/3 from above. This will make the numbers look good, but the FDA should be spending even less time on #2 than it spends on the #1 category of submissions. The FDA should also get involved in group #3 submissions much earlier.

FDA Approval Process

The types of submissions that need more FDA reviewer time are devices that are higher in risk and where special controls guidance documents and or ISO Standards have not already been established for performance and safety testing criteria (i.e., – Category #3 above). In these cases, when a company tries to obtain some feedback from the FDA, they are asked to request a pre-IDE meeting. The company will not be necessarily performing a clinical trial, but this is the only vehicle the FDA has for justifying the time it spends providing feedback on proposed verification and validation testing plans. The FDA needs to develop a new model that is ideally suited for 510(k) products where guidance and Standards do not exist. This would also have the effect of reducing the number of “Not Substantially Equivalent” (NSE) letters the FDA issues.

If a company is developing a device that already has an applicable special controls document or ISO Standard, then the 510(k) pathway should be well-defined without the FDA’s help. Unfortunately, there is no easy mechanism for ensuring compliance with these external standards. This type of submission would benefit from software-controlled submissions and or pre-screening of submissions by third-party reviewers. The Turbo 510(k) software tool could lend itself to software-controlled submissions, but a proliferation of the Turbo 510(k) has been limited.

Submitting a 510(k)

If a company does not submit a 510(k) with all the required elements of a guidance document, the submission should not be processed. Implementation of validated software tools for each 3-letter product code would prevent incomplete submissions. At the very least, companies should be required to provide a rationale for any sections of submission that are not applicable.

One example of a possible software solution is currently used by third-party auditors at BSI. BSI uses a software tool that will not allow the auditor to generate a final report unless all the required elements have been completed. The FDA could use the existing screening checklist and convert this into a similar “SmartForm.” If the submission does not have all the required elements of the checklist, the submission form could not be generated from the software. This forces the task of pre-screening reviews back upon the submitter with the aid of a validated software tool.

The most significant shortfall of the Triage program is the target product types. IVD devices are quite different from other device types. Each IVD has unique chemistry, and there are a limited number of Guidance documents for IVDs, and IVD submissions represent only 10-20% of all submissions. Orthopedic, cardiovascular, general/plastic surgery and radiology devices each represent more than 10% of the submissions, and collectively they represent half of the submissions. These types of devices also have both special controls documents and ISO Standards defining the design inputs for design verification. Therefore, these four device types would be a better choice for a pilot program to expedite reviews.

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