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July 29, 2019

Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices

Author Affiliations
  • 1UCSF School of Medicine, San Francisco, California
  • 2Philip R. Lee Institute for Health Policy Studies, San Francisco, California
  • 3Editor, JAMA Internal Medicine
  • 4San Francisco Veterans Affairs Medical Center, San Francisco, California
JAMA. 2019;322(10):927-928. doi:10.1001/jama.2019.10191

Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. A 2018 Netflix documentary, The Bleeding Edge, highlighted multiple such medical devices, 2 of which, Essure (a device for female sterilization) and transvaginal mesh for pelvic organ prolapse, were taken off the market after the film’s release. Recent Kaiser Health News stories reported that more than 1 million medical device adverse event reports had been sealed from public view by the US Food and Drug Administration (FDA).1The New York Times recently called for reforms in device regulation in an editorial entitled “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.”2

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