When FDA Sees Risk, Who Makes the Case for Benefit?
How do you balance protecting patients from risk with getting potentially life-changing medical technology to the people who need it?
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Laura Rose, former FDA reviewer and assistant director and current Chief Regulatory Officer at Deffai, to dig into one of the hardest parts of medical device regulation: benefit-risk decision-making.
Laura shares her perspective from eight years at the FDA. She explains how reviewers approach uncertainty and seeing technologies go wrong can make regulators more conservative. She also discusses the importance of considering what happens to patients when a new technology isn't available.
The conversation also turns to industry. Companies need to acknowledge real device risks and understand the concern behind an FDA deficiency. In some cases, a strong scientific or regulatory rationale may resolve the issue without additional testing.
Then, the team tackles the Breakthrough Devices Program. With 1,320 designations granted since the program began, what is Breakthrough designation actually supposed to accomplish? They discuss varying evidentiary expectations across FDA offices and whether the program needs a clearer purpose.
They also look at two newly announced Breakthrough devices: Beyond Air®'s LungFit® GO for at-home inhaled nitric oxide therapy and CorTec's fully implantable Brain Interchange™ BCI, designed to allow people with non-progressive quadriplegia to control a computer cursor through thought alone.
Additional topics include:
How to respond when an FDA request seems unreasonable
Virtual Incision's MIRA™ Surgical System and its expanded hysterectomy indication
The FDA's updated position on PFAS and fluoropolymers in medical devices
New product-specific guidance for dental composite resins and curing lights
Why MSDS requests can catch sponsors off guard
The FDA's September 25 regulatory science meeting
GenAI regulation and the evolving FDA discussion paper
The latest MedSun report
Why dental X-rays may be among the most horrifying images in medicine
Why the right number of dogs may be less about quantity and more about total volume
