Interacting Early with the FDA During a 510(k) Review

The Third Party Review Program guidance outlines situations where Third Party Review Organizations (3P510k Review Organizations) should contact the FDA before or during their review of a 510(k) submission. This allows the FDA to provide 3P510k Review Organizations with answers to regulatory questions regarding current FDA processes and policies. Answers obtained through this process are intended to help 3P510k Review Organizations produce FDA-equivalent 510(k) reviews and recommendations and may eliminate FDA re-review of a 510(k) submission.

* If these timeframes cannot be met by the FDA, the FDA intends to work with the 3P510(k) Review Organization to establish a reasonable timeframe to provide feedback.

Prior to contacting the FDA, the 3P510k Review Organization is expected to conduct a review of all available resources to address certain questions. Resources may include:

• Relevant guidance documents, including device-specific and horizontal guidances (for example, biocompatibility, software, sterility) found in the FDA's guidance database;
• Regulatory requirements for certain class II devices, also known as special controls, that apply to the device type;
• Postmarket databases for recalls and adverse events;
• FDA communications such as press releases on recalls, market withdrawals, safety reports, and safety communications;
• Premarket review information about the predicate device to which a 510(k) submitter is comparing its device, or other similar device(s), including Indications for Use Statements, 510(k) Summaries, Decision Summaries, and the FDA's decision letters. This information can be accessed in the FDA's 510(k) database; and
• If an applicant wishes to utilize standards, the 3P510k Review Organization should review the FDA's guidance on "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices".
• Review Memos for Third Party 510(k) Reviewers

Questions submitted to FDA should be clear, specific, and relevant to the 510(k) submission. They should be geared toward helping answer whether the device under review is substantially equivalent to the identified predicate device. Questions that lead to productive interactions between the 3P510k Review Organization and the FDA staff typically share the following characteristics:

• Take into consideration and include references to applicable guidance document(s) and standard(s):
  • For instance, a 3P510k Review Organization can request clarification of a guidance or standard to ensure its interpretation is correct;
  • A 3P510k Review Organization provides an explanation of why it believes information provided by a 510(k) submitter does not align with guidance or standards and then seeks FDA feedback on such assessment;
• Take into consideration postmarket data such as recalls and MDRs and previous discussions (for example, unsuccessful marketing applications, pre-submissions, etc.) with the FDA;
• Use previous FDA interactions on a third party 510(k) submission from their 3P510k Review Organization for that product code as a reference or starting point to see if any review practices have changed (provide submission numbers or copies of previous e-mail interactions); and
• Provide data as supportive context for a specific proposal, if necessary;
  • For instance, a question may include a summary of nonclinical or clinical study data to help the FDA staff develop feedback in response to a specific proposal.
  • 3P510k Review Organizations should not submit data or test protocols for pre-review. Likewise, the FDA should not request data or test protocols for pre-review.

Sample Questions

Regulatory Strategy Questions

• Are there concerns with the eligibility of the proposed device? While the product code (procode) XXX is Third Party eligible, this modification may fall under factor YYY in the guidance that may make this ineligible for third party review. FDA, do you concur that this device given the proposed modifications, appears eligible for third party review?

Sterilization Questions

• The 510(k) Submitter has followed standard XXX to validate their sterilization process. Their sterilization challenge device does not meet the requirements outlined in that standard; therefore, we intend to ask for additional information. Does FDA agree with this approach?

Guidance Questions

• The following guidance document XXX for this device type recommends that we should look for YYY data to demonstrate substantiate equivalence. The 510(k) submitter has instead provided ZZZ data. We believe that ZZZ data are sufficient as an alternative to address the risks outlined in the guidance for reasons A, B, and C. Does FDA agree with this?

To submit questions, the 3P510k Review Organization may call their FDA point of contact or send an email to 3P510k@fda.hhs.gov.