Medical Device Regulation
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 Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical device sterilization processes.
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AHA comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.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.
The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk.
The Centers for Medicare & Medicaid Services will increase the number of opportunities to apply for Healthcare Common Procedure Coding System Level II codes from once per year to quarterly for new drugs and semiannually for new medical devices.