Regulatory Tips & Observations from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies? On today’s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies. She shares her perspective on them, especially as a former FDA reviewer, current consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices. Some of the highlights of the show include: ● The regulatory path to get devices approved has been under scrutiny for decades. Companies may think it’s too hard or cut corners with FDA regulations. ● Get a second opinion, conduct research, and ask questions about medical devices because your or your loved one’s life may depend on the device. ● FDA reviewers may go into industry because they know how to regulate devices. They understand why regulations are in place to make devices safe, effective. ● If a company does testing, gives the FDA what it needs, and participates in the pre-submission process, the likelihood of a device being approved is greater. ● When preparing regulatory documents, review information available on the FDA’s Website and contact DICE and/or regulatory consultant. ● Consider pre-submission if your company isn’t confident about testing needed or is an early startup that needs guidance on its regulator strategy. ● AI Letter: Puts your device submission on hold for issues and deficiencies that need to be addressed within 180 days. Avoid getting an NSE letter! ● Update your 510(k) summary if a predicate device has been subject to a recall. FDA wants to make sure the new device does not have the same issues.