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Common Mistakes That Can Tank Your FDA 510(k) Submission
FromGlobal Medical Device Podcast powered by Greenlight Guru
Common Mistakes That Can Tank Your FDA 510(k) Submission
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
37 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s 75%. The vast majority are rejected for poor substantial equivalence, which, as you know, defeats the purpose of the submission in the first place. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about some common mistakes that can sink your 510(k) submission.
Some of the highlights of the show include:
● Jon’s motivation for writing an article about common mistakes that sink a 510(k) clearance.
● The importance of consistency with documentation and using the checklist off of the Refuse to Accept Policy.
● Why the Refuse to Accept guidance contains some minutiae.
● Recommendations on providing the required testing and following the best practices.
● Suggestions on how to handle showing a long shelf life.
● Thoughts on why the FDA is reluctant to accept promissory notes when a submission is not complete.
● Thoughts on risk management and why it’s an important part of a submission.
● The most important takeaways regarding the 510(k) rejection problem.
Some of the highlights of the show include:
● Jon’s motivation for writing an article about common mistakes that sink a 510(k) clearance.
● The importance of consistency with documentation and using the checklist off of the Refuse to Accept Policy.
● Why the Refuse to Accept guidance contains some minutiae.
● Recommendations on providing the required testing and following the best practices.
● Suggestions on how to handle showing a long shelf life.
● Thoughts on why the FDA is reluctant to accept promissory notes when a submission is not complete.
● Thoughts on risk management and why it’s an important part of a submission.
● The most important takeaways regarding the 510(k) rejection problem.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer: One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation... by Global Medical Device Podcast powered by Greenlight Guru