New FDA Refuse to Accept 510(k) Policy Guidance

The FDA has released a new Guidance Document titled “Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff.”  This new 76-page guidance on the FDA Refuse to Accept Policy replaces the previous 2012 Edition as well as the “510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1,” from 5/1994 and the “Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy” from 6/1993.

The document provides you with guidance on the FDA Refuse to Accept Policy.  That is, it explains the criteria that the FDA uses in order to determine if a 510(k) submission for medical device approval as a  substantially equivalent device meets the minimum requirements for acceptability.  If so, then the submission can be moved into the deeper review process itself.

What could be some triggers that would result in a 510(k) submission being refused?  Well, the submission might be administratively incomplete.  In this case the FDA would reject your submission but let you know what the missing elements are.  However, it’s best to avoid this outcome in the first place, so this guidance document contains checklists in the appendices that can help you with the contents and elements you’ll need to pass this barrier.  Over 80% of the document consists of these three appendices:  Appendix A, 24 pages, for the checklist for traditional 510(k)s, Appendix B, 26 pages, for abbreviated 510(k)s, and Appendix C, 10 pages, for special 510(k)s.

What else is included in this FDA Refuse to Accept Guidance document?  It starts out with a section on the purpose of the guidance, then discusses the background of this new edition.  You’ll also get an overview of the actual 510(k) process and rationale, since there are specific requirements that substantially equivalent medical devices must meet.

The next section in the publication covers it’s scope.  This explains the use of the Guidance and it’s Appendices for specific kinds of 510(k) submissions in order to insure a consistent approach for the acceptance review process itself.  Section 4 provides you with an overview of the pre-submission interaction.  You might wonder about this, but the FDA encourages this type of pre-submittal contact as a way to familiarize a submitter with the process in general and to discuss any “novel” issues their submission may contain.  You’ll also find links to a wide range of other resources in this section as well.

Section 5 directly addresses the issues surrounding the FDA Refuse to Accept policies and procedures themselves.   Here you’ll learn what the administrative process is when the FDA first receives 510(k) submissions.  This includes how much time is required for the first review and acceptance or rejection, what criteria are using at that time, and how they communicate with you regarding the results.  It also provides you with possible actions you can take should your submission be rejected.

Section 6 is a review of the principles that drive the refuse to accept decision making process.  These principles are:

  • Acceptance should not be based on a substantive review of the information provided in the 510(k) notification.
  • FDA staff should determine whether the submitter provided a justification for any alternative approach.
  • Device-specific and cross-cutting guidance documents, applicable recognized standards, and applicable regulations will be considered when making an RTA determination.

Lastly, Section 7 is a list of preliminary questions that are found on the first page of each of the checklists and are used for initial screening.  Section 8 in contrast reviews the balance of the process engendered by the checklists.

Now to get a copy.  FDA Guidance documents are widely available.  However, you get the added bonus of our free notification service when you purchase your FDA publications from Document Center Inc.  You can get the FDA Guidance Documents in either paper format or for pdf download at our website, www.document-center.com.  Here’s a link directly to the order page for the FDA Refuse to Accept Policy Guidance.

Many of our Document Center Inc. customers add FDA Guidance documents to their Standards Online multi-user subscription service as well.  This is a way for all your staff to be able to review your standards collection online and is very popular with our clients.  For more information on this or any standards question, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!