Run the FDA RTA & e-COPY 510(k) Gauntlet
- Friday, 14 November 2014 16:14
- Elaine Duncan
Filing a 510(k) according to the current FDA “refuse to accept” policy can be challenging. The former checklist of a few pages is now more than 26 pages for a traditional 510(k). The new policy is supposed to help FDA focus its resources on those submissions which are complete. Unfortunately some of the quirks of the checklist and the UBER-interpretations of guidance documents and regulations have caught some folks with one or more recycles of their 510(k) submission. At Paladin Medical, Inc. we have the experience to help you avoid the recycling syndrome by working with you early to plan the content of your 510(k).
Working efficiently and effectively with FDA is much more than checking boxes. But in like token, we understand that the initial Refuse To Accept review is critical to speedy processing. For example, we use the checklist to annotate and direct the initial reviewers attention to the location in the document that the required elements can be found. We know where the trip wires are in the checklist that can stall an otherwise complete submission.
We’d like to share these tips and tricks of the trade with you and discuss your next submission project. Maybe we can help, or maybe just a look at our presentation given to the LifeScience Alley “Smoldering Submission Issues” can give you the help you need. Please go to the CONTACT PALADIN MEDICAL tab and sign in for the information request. We can send a copy of the presentation to your email address.