Ship & Print Your FDA eCopy
3 min reading time
Last week I received this question specifically about 510(k) reviews, but I expanded the question to address both types of submissions.
The most important thing is to be aware of the review process for submissions and understand the chain of command. Don’t break the chain of command and impatience is not appreciated by busy regulators. The FDA specifically states that they do not want to you to contact reviewers to check on the status of a review. However, if a deadline passes and you have not received communication–contact the reviewer politely.
Good Example: I shipped two 510(k)s on the same day to the FDA. Both were received according to tracking information. I received the acknowledgement letter for one of the two within 36 hours, but I heard nothing regarding the second. You are supposed to receive an acknowledgement letter within seven days of receipt that the eCopy has been successfully uploaded and the 510(k) submission is accepted. Usually this process only takes 24 hours. On the fourth day I started to wonder and sent an email to the document center. Later that day I received an acknowledgement letter. I was careful in my email to not accuse the document center of making a mistake and the email was addressed directly to the document center.
Bad Example: A client of mine submitted a technical file to a Notified Body (NB) by FEDEX. The document was in a large binder. The NB required that all submissions be in PDF format. The NB scanned the binder to facilitate a faster review, but the scans were in groups of 100 pages rather than grouping by section. The client heard nothing for two months so they complained to the Head of the NB in a harshly worded voice message. The reviewer responded the next day by indicating that the submission format was unacceptable which caused a significant delay. Two weeks later they received a long list of deficiencies that took months to address. In this case the client was not aware of submission requirements and worked around the reviewer by complaining directly to the Head of the NB before even speaking with the reviewer.
Ask your NB who technical files should be submitted to, how to format files and when you can expect to hear back from the reviewer with a first round of questions. I recommend sending an initial email to the reviewer to confirm receipt and to restate what you were told to expect. Ask the reviewer to confirm. If you don’t receive a response in a week, ask again. If you don’t hear back in another week, call and be polite. You should continue to keep in touch biweekly with the reviewer, but weekly communication is excessive.
The FDA has a well defined process. First response is acceptance within seven days, but typically acknowledgement is within 24 hours. Second response is the result of an RTA checklist within 15 days. If the RTA process is successful, then you are in the substantive review. If the submission is placed on RTA Hold, then you have instructions to resubmit and there will be no further communication unless you contact the reviewer with a clarification question. Once you are in the substantive review you will not hear anything back from a reviewer until 60 days. If you hear something earlier be thankful. It is not appropriate to contact the reviewer to check status. You should carefully check your spam folder and all email folders using the K number you were given as the search criteria (e.g., “K123456”). If you receive a request for additional information you can contact the reviewer to clarify any part of the request for information. If you are notified that you have entered the interactive review process, then the reviewer believes they can reach a final decision within 30 more days. You should communicate promptly with the reviewer in exactly the manner that they specify. Interactive reviews are “good news” and be thankful.
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