FDA medical device regs, safety checks questioned by AMA ethics journal

MEDTECHDIVE – September 29, 2021 – Nick Paul Taylor

The AMA Journal of Ethics has taken a deep dive into U.S. regulation of medical devices, raising questions about whether FDA is striking the right balance between supporting innovation and protecting patients.

In setting up the issue, Ariel Wampler, a plastic and reconstructive surgery physician at Lahey Hospital and Medical Center in Massachusetts, shared data on the regulation, use of and impact of medical devices. Most of the statistics date back years but still provide a snapshot of the case against the current approach. Wampler notes that less than 1% of medical devices went through two large clinical trials, as is standard for pharmaceuticals, from 2003 to 2007.

As it’s typically easier and safer to discontinue use of a drug than an implant, Wampler suggests it “might be reasonable” to expect some devices be held to higher safety standards than pharmaceuticals.

Reported serious safety problems are exceedingly rare — less than 1% of devices cleared or approved between 2004 and 2009 have been subject to a Class I recall, though the recall system itself has also been criticized as being piecemeal and not comprehensive. Clinical trials of implants can be more complex, expensive and ethically problematic than studies of drugs.

Read Full Article…