Major Changes Coming To Controversial 510(K) Medical Device Approval Process, FDA Officials Say
The FDA is considering changes to its highly criticized 510(k) medical device approval program.…
The FDA is considering changes to its highly criticized 510(k) medical device approval program.…
A worldwide investigation raises concerns about the state of medical devices, how they are approved, and what happens when they are deemed to be unsafe.…
The FDA will hold a meeting next month to address the development of pediatric medical devices, which experts say has fallen behind the development of devices for adults.…
The FDA has announced new plans to speed up the approval of new medical devices, raising some concerns about patient safety.…
The FDA has published a list of more than 1,000 medical devices that are now exempt from premarket approval requirements.…
A new editorial say failures to more quickly identify and react to power morcellator cancer risk were in part due to a lack of a sound post-marketing surveillance system to ensure the safety and effectiveness of medical devices once they are on the market.…
The FDA is considering further reductions in requirements for moderate-risk medical devices to hit the market, following passage of the 21st Century Cures Act late last year, which some say would remove virtually all oversight for some devices before they are used on patients.…
A GAO report indicates that the FDA’s adverse reporting system and its voluntary nature may have delayed the agency from detecting heightened cancer risks linked to the use of power morcellators.…
A new study suggests that active surveillance of medical devices is far more effective than the current adverse event reporting system used to detect safety problems.…
Federal regulators have finalized broad requirements on the release of information on clinical trials affecting products regulated by the FDA or which have received federal funding.…