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There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants.
Veteran regulatory consultant Michael Drues thinks the problems outlined in the reports echo concerns going all the way back to when the FDA started regulating medical devices in 1976.
They raise similar questions, too. “What do we do to prevent them? How do we prevent more from happening?” Drues said during his newest podcast with Medical Design & Outsourcing.
Drues is skeptical whether some of the changes proposed at FDA will work, including a proposal to move away from using predicate devices more than 10 years old in the 510(k) clearance process. No matter what, Drues has noticed agency regulators interpreting regulations differently than in the past, especially when it comes to 510(k) clearances.
“Just over the last one or two months, I’ve had a few devices that we’ve brought to the FDA with strong cases to bring to the market as a 510(k) – FDA has been pushing hard to do a de novo instead,” Drues said.
Listen to the full podcast with Drues:
