FDA Archives - In Compliance Magazine

FDA Releases New Video on Cybersecurity in Healthcare Facilities

As part of its effort to protect healthcare workers and patients from equipment malfunction attributable to cybersecurity breaches, the U.S. Food and Drug Administration (FDA) has released a new video to help h... Read More...

FDA Updates Consumer Information on OTC Hearing Aids

In a separate development, the U.S. Food and Drug Administration (FDA) has also updated its information webpage for consumers on over-the-counter (OTC) hearing aids. Authorized by the FDA for sale in October... Read More...

FDA Releases Latest Third-Party Review Performance Report

The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process. ... Read More...

FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new voluntary pilot program aimed at improving technologies and practices used in the sterilization of medical devices. According t... Read More...

FDA Posts Updated FAQs on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released an updated list of frequently asked questions (FAQs) on the agency’s requirements regarding cybersecurity provisions applicable to medical devices. Pu... Read More...

Biotech Company to Pay $12 Million for False Compliance Claims

A manufacturer of cochlear implants has agreed to pay a major financial penalty for falsely claiming that its U.S. Food and Drug Administration (FDA)-approved product complied with the requirements of an indust... Read More...

FDA Releases ASCA Annual Report for 2022

The U.S. Food and Drug Administration (FDA) has released its annual report on its voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot, a program intended to more effectively leverage widely ac... Read More...

FDA Releases Third-Party Review Performance Report

The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process. ... Read More...

FDA to Host Webinar on In Vitro Diagnostic Devices EMC

The U.S. Food and Drug Administration (FDA) will host a webinar in early February on its requirements regarding the electromagnetic compatibility (EMC) of in vitro diagnostic (IVD) medical devices. According... Read More...

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help medical device manufacturers identify human factors information to include in device marketing submissions. Issued in ... Read More...