The New Special 510(k)

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it really new? Or has its existing program just been repackaged? On today’s episode, I talk to Mike Drues of Vascular Sciences to determine the correct answer and what it means for you, your company, and medical device. Some of the highlights of the show include: ● FDA has 161 guidances now related to 510(k)s. Instead of more guidance, the solution should be to get people to think about and use 510(k) correctly. ● What’s new, if anything? There’s less focus on a change to high-level labeling, intended use, and technology; but more focus on testing to evaluate the change. ● New guidance also emphasizes risk management and quality/design controls. ● Pilot program guidance seems vague and ambiguous - use that to your advantage. Understand its intent: Simplify the process to improve efficiency. ● Does a Special 510(k) apply to your device? What is the criteria? ● If making a change to a device, is testing and notification always necessary? No, but you need to demonstrate and analyze the change. ● Change management is an issue and done poorly by most in the industry. Most companies want to take the path of least resistance and avoid the FDA. ● Under the new program, you submit a Special 510(k), and FDA reviews it. But a mechanism is needed where people can go to the FDA beforehand to discuss it.