On August 4, 2015, the U.S. Food and Drug Administration (FDA) published an updated “Refuse to Accept Policy for 510(k)s.” This policy will become effective on October 1, 2015, and will replace the previous version of the policy published in 2012. When FDA receives a 510(k) submission, the agency first checks the submission for completeness. If the 510(k) is complete, FDA will conduct a more substantive review of the quality of the data. The Refuse to Accept Policy for 510(k)s outlines FDA procedures and criteria for determining whether a submitted 510(k) is complete and therefore acceptable for substantive review.
The policy is presented in the form of a checklist. Below are just a few examples of criteria included in the 510(k) completion checklist:
- Does the submission contain a Table of Contents?
- Are all contents written in English?
- Does the submission contain an Indication for Use Statement?
- Does the submission contain clinical data?
- Does the submission include proposed labeling, including instructions for use and an operator’s manual?
Along with a few additions and deletions of criteria, a notable update in the 2015 policy is the addition of alternative options for certain criteria. For example, the 2012 policy contains the following criterion:
“Submission contains representative engineering drawing(s), schematics, illustrations and/or figures of the device that are clear, legible, labeled, and include dimensions.”
The 2015 policy still includes this criterion, but it gives submitters the option to instead include a statement that drawings and schematics are not applicable to the device. This option is now found in multiple criteria in the policy.
The checklist provided for a traditional 510(k) submission included 24 pages of criteria. Many companies have trouble ensuring their 510(k) submission is correctly formatted and contains the many required elements. Registrar Corp’s Regulatory Specialists can provide a 510(k) administrative review that includes:
- A review of your product’s user guide and labeling (to be submitted with your 510(k))
- Verification of the structure, format, and required elements of your 510(k)
Registrar Corp will also facilitate the submission of your 510(k) and the associated fees to FDA, as well as correspond with FDA regarding the submission on your behalf. For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.