Introworks and DuVal & Associates surveyed more than 250 medical technology executives, regulatory affairs, and industry consultants.
For the med-tech and medical device companies we serve, the 510(k) process is a key driver in product launches. The better we can all understand companies’ experience at this critical juncture in the regulatory process, the more effectively we can support the industry and drive innovation.
To that end, ten years ago Introworks teamed with DuVal & Associates, an FDA regulatory law firm specializing in product approvals, on an industry survey to gain insights on companies’ experience working with the FDA on the 510(k) program.
A lot has changed since then. We repeated the process this year, with NAMSA joining in sponsoring the survey, which solicited input from a wide range of med device companies on their perception and experience with the 510(k) process.
Comparing the data, we see encouraging trends, along with continued opportunities for improvement:
- There is a significant need for training of review staff on legal/regulatory issues related to 510(k) submissions
- FDA should continue to build on the trend of acknowledging Least Burdensome principles by improving the transparency of how principles were applied
- FDA can improve on performance related to AINE letters, issuing them (when appropriate) earlier in the review process, rather than after multiple rounds of questions and responses over an extended period of time
As champions of the industry, Introworks and DuVal & Associates plan to continue this survey on a regular basis. After all, what gets measured, gets managed.
If you have specific questions about the survey, please contact us directly and we will be happy to answer your questions.