Medical Device Regulation
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical…
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that…
On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro…
The FDA has updated its recognized consensus standards for medical devices to include more options for device sponsors to consider during premarket review. Find out how this affects your medical device.
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations.
The Food and Drug Administration released a discussion paper on 3D printing of medical devices at the point of care to facilitate input from stakeholders and others to inform future guidance. The agency will accept comments on the paper for 60 days.
AHA comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.
The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope.
The Food and Drug Administration today alerted the public to growing concern about the potential for medical device shortages as facilities that sterilize devices using ethylene oxide close.