Some 510(k) Q & A

Here are some questions I recently received by a company doing it's own 510(k), with my brief responses:

1.  Re:  Traditional 510(k), Section 10: Is it about summary of performance testing?   

     biocompatibility testing and bench  testing? 

     Ans:  Yes to all.  You either do any required tests or pay a lab to do them.  If you do them,   

     they have to be done per applicable standards.  E.g., Biocompatibility test requirements are    

     spelled out in ISO 10993.

2.  Design control?  How can I get that?

     Ans:  You should be currently developing your product under Design Control.  This means   

     doing it under 21 CFR 820.30, and addressing the 9 elements a 10th element is a Design Control       

     SOP; identical10 requirements in ISO 13485:2016 7.3, Design and Development Planning,  in your  

     documentation and systems:
     1) Design and Development Planning (e.g., Gantt chart or SOP-defined or ...; w/ "Start Date");
     2) Design input (requirements, standards, guidance documents, et al);
     3) Design output (drawings, specs, assembly / test SOPs, code, and similar);
     4) Design review(s) (to ensure past activities are complete, and lay out next actions; with an      
          impartial member of the review team);
     5) Design verification (I define by "working definitions" as testing, checking, inspection...);
     6) Design validation (I define as the collection of verifications);
     7) Design transfer (complete approved production-ready documents now in production);
     8) Design changes (the basic reason for Design Control - ensure changes are reviewed and 
          verified, then approved, all documented, prior to implementation during development);
     9) Design History File (DHF) (- proof that 1-8 were performed and the history of each).  
     As 820.30 requires, the results are documented in a DHF (Design History File).  
     If you haven't done so already, download the entire medical device  

     CGMPs, 21 CFR 820, from the fda.gov website.  You have to follow all of it, or your contract  

     manufacturer will follow much of it and you the rest.  Your  510(k) submission to the FDA is a

     tacit admission that you've done that, and you will later by audited by the FDA to ensure

     compliance.  That means also having SOPs and a QM (Quality Manual) that is also followed.

3.  About the CGMPs, I need to ask to the company whom I'm going to choose make my device   

     to show me the certification.

     Ans:  There is no legitimate US FDA CGMP (US 21 CFR 820) "certification".  If they are subject 

     to the US FDA CGMPs, they are registered with the FDA (as you will have to do), and subject

     to CGMP audit by the FDA.  You could ask to see copies of past FDA audits and the  

     company's responses.  And you can perform your own vendor audit to ensure their

     compliance, requiring you to get familiar with the CGMPs (or hire a consultant to perform   

     such an audit for your). This is for US sales.  For outside the US sales, the company would  

     have to have a quality management system (QMS) certified by a Notified-Body (BSI, TUV,

     DNV, UL ...), hired by the company, and that company's manufacturing system and product

     testing / lot release requirements / methods would also have to have an additional audit /

     certificate from their N-B.

As indicated above, a 510(k) is only one of many steps required by the U.S. FDA in order for a company to market devices in the U.S.

[note:  The FDA prefers the term "inspection" to "audit"]

-- John E. Lincoln,  www.jelincoln.com

Updated 09/06/2023.