FDA Archives - In Compliance Magazine

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help ensure confidence in computers and automated data processing systems used in the production of medical devices. Publis... Read More...

FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug Administration (FDA) may be adversely impacting the agency’s ability to thoroughly assess the security of medical devices against c... Read More...

FDA Updates Recognized Standards List

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...

FDA to Authorize Non-Prescription Hearing Aids

In a milestone development, the U.S. Food and Drug Administration (FDA) will soon authorize non-prescription hearing aids, potentially giving millions of hearing-impaired people access to affordable hearing dev... Read More...

FDA Issues Updated Guidance on Medical Device UDI Requirements

The U.S. Food and Drug Administration (FDA) has released an updated Guidance on the unique device identification (UDI) requirements for medical devices, easing its requirements for certain types of low-risk dev... Read More...

FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform for uploading and tracking the progress of premarket submissions for medical devices. According to a posting on the FDA’s... Read More...

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility (EMC) in connection with medical devices, including in vitro diagnostic (IVD) devices. Posted to the FD... Read More...

FDA Expands Efforts to Accredit Testing Laboratories Under ASCA Pilot Program

The U.S. Food and Drug Administration (FDA) is ramping up its efforts to expand the use of its voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot, a program intended to more effectively lever... Read More...

FDA Updates List of Recognized Standards

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain its criteria for assessing whether a medical device premarket notification (510(k)) submission meets the agency’s minimum re... Read More...