4 key factors to getting FDA 510k Clearance in 2-3 months


FDA 510k Clearance in 2 months? Yes, it’s possible. We have recently completed a regulatory submission and approval in an extremely short amount of time. On average, it takes 5 months for the FDA to review and clear a medical device 510(k) application. Most people think they have a good chance of getting their 510(k) clearance within 90 days, but that’s not the reality. The reality is that only 28% of 510(k) submissions cleared in 2013 were done within 3 months. So, the 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared. However, we just completed leading a project in which the submission was submitted at the end of Aug, and the project received clearance before the end of Oct. That’s less than 2 months for clearance! As many of you know, this is an extremely fast, and non-typical clearance time, but given the expertise of our team and our synchronistic program management approach, we know this is something that can be replicated, given the right team, leadership, situation and attitude. The 4 key Factors that will make or break a quick and efficient regulatory clearance are:

  1. Agile Program Management: Use Agile or Hybrid Agile/Waterfall Development, Efficient Team Meetings, Cross Functional Support, and Clear Critical Paths managed well.

  2. Regulatory Strategy and Execution: Use of Predicates, Submission Formatting, and FDA contacts.

  3. Design Control Procedures and Design History Files: Relevance to what’s truly needed, staying in compliance, but not going overboard.

  4. Technology Development: Concurrent Engineering, Simplicity, Features and Specifications, Product and Technology Roadmapping. Also, use of existing technology, components and qualified vendors as much as possible.

If you have an exciting medical device or biotechnology that you need some guidance on for, and or are working on a regulatory submission, and would like to hear more, please let us know, and we'd be happy to share what we’ve done and how we did it.


#FDA #510k #Startups

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