What is the best course of action for a regulatory professional when contacted by an FDA reviewer with questions about a submitted 510(k) application?

When a regulatory professional is contacted by an FDA reviewer with questions about a submitted 510(k) application, the best approach is to send a letter with anticipated response time. This choice demonstrates professionalism and respect for the review process while acknowledging the FDA's timeline for inquiries and ensuring that the regulatory professional is managing the expectations involved.

Sending a letter outlining the anticipated response time shows that the regulatory professional is taking the inquiry seriously and plans to provide a thoughtful and thorough answer. It also keeps the lines of communication open between both parties, which can be beneficial for clarifying questions and addressing concerns efficiently. Moreover, it allows the regulator to know when to expect additional information, thereby facilitating the review process.

While contacting the FDA for clarification may seem like a proactive approach, it could also lead to further delays if the question is already clear in the reviewer's inquiry. Similarly, requesting a meeting could be appropriate in some situations, but it may not be necessary or the most efficient means to address specific questions. Sending a comprehensive report, while thorough, may overwhelm the reviewer with unnecessary detail instead of focusing on the specific questions asked.

Overall, responding with a letter that sets forth the expected timeframe for responses aligns well with best practices in regulatory compliance and proactive communication with regulatory authorities.