If an FDA reviewer has a lengthy list of questions regarding a submitted 510(k) application, what is the best course of action for a regulatory professional?

The best course of action in this scenario is to send a letter with an anticipated response time. This approach demonstrates proactive communication and acknowledges the FDA reviewer's concerns regarding the 510(k) application. By providing a timeframe for when the regulatory professional will respond to the lengthy list of questions, it establishes a clear expectation for both parties and maintains a collaborative relationship with the FDA.

In regulatory affairs, timely and transparent communication is crucial for successful interactions with regulatory bodies. By giving an anticipated response time, the professional can manage the reviewer's expectations and show their commitment to addressing the queries effectively.

Other options may not be as beneficial in this context. Requesting a meeting with the district office or the panel could potentially lead to confusion or delay, especially if there isn't a clear agenda or if the queries can be addressed through correspondence. Simple responses are often more efficient in initial communications when a reviewer's questions need detailed attention. Moreover, responding within 90 days, while seemingly reasonable, lacks the proactive communication component that a letter with an anticipated response time offers.