Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

inHarmony Announces FDA Registration Across Vibroacoustic and Red Light Therapy Product Lines

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...
NBC New York

FDA moves to rehire medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
Mad in AmericaOpinion

The FDA Allows Ineffective Devices to Come to Market

The main take-home message is that regulatory approval doesn't mean a device works. It means it's safe,” according to Katya ...
Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

Nearly a third of FDA medical device adverse events reported late: study

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...

Dangerous medical implants and devices

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) WASHINGTON (AP) — Barely a week after mass firings at the ...
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...