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Takeaways from the FDA Small Business Regulatory Education for Industry (REdI) Conference 

QA Consulting attended the FDA Small Business Regulatory Education for Industry (REdI) Conference held September 25-26, 2013 in Bethesda, Maryland.  Pre-submission, quality system, and post-market topics were covered by FDA staff.  Below are our key takeaways from the meeting by topic.

  • While draft guidance documents are not required to be followed, FDA emphasized that they should be utilized as they are a resource for learning how FDA thinks about a topic.
  • Industry is encouraged to use the Total Product Life Cycle database to learn more about similar products on the market and issues that have arisen with them.
  • More and more inspectional information is due to be posted online. For example, EIRs are going to be posted online– they will be redacted.
  • FDA will be increasing the number of inspections of contract manufacturers.
510(k) Submissions
  • Pay close attention to the Refuse to Accept checklists that were issued on December 31, 2012.  Since the inception of the Refuse to Accept policy, 66% of the 510(k) submissions received have not been accepted.  The most commonly missed elements that result in FDA’s refusal to accept a 510(k) submission include:
–  shelf life details
–  prior submissions for which FDA provided feedback
–  test reports for completed performance tests
–  510(k) summary elements per 21 CFR 807.92
–  consistent Indications for Use (IFU) throughout the submission
–  contact classification for biocompatibility testing
–  analysis of why differences between subject and predicate device do not render the device not substantially equivalent (NSE).
  • For critical testing and validation, promise statements are no longer accepted in 510(k) submissions, e.g. sterilization validation must be completed in order to receive clearance.
  • It is extremely rare not to receive a request for additional information on a 510(k) submission.
Quality System
  • Although the word “risk” is mentioned only once in the regulation itself (820.30), the preamble lists the word “risk” more than 30 times.  This indicates FDA considers that risk should be considered throughout the product life cycle.
  • FDA investigators are spending more time looking at Purchasing Controls.  Warning Letter data shows that the number of Warning Letters that cite Purchasing Controls is trending upward.
  • It is important to contractually specify the responsibilities and controls to be exercised by a supplier and the specification developer.  Use of the Global Harmonization Task Force’s guidance documents on supplier control was recommended.  A risk based approach should be taken to managing suppliers.

Issues within the CAPA system are the most frequently cited topic in Warning Letters.  FDA investigators will always look at the CAPA system.  If the CAPA system is not in a state of control, FDA will wonder what assurance they have that the rest of the systems are in a state of control.