FDA Archives - In Compliance Magazine

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FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help medical device manufacturers identify human factors information to include in device marketing submissions.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

FDA Clarifies Definition of “Device”

The U.S. Food and Drug Administration (FDA) recently issued a guidance document to clarify the agency’s use of the term “device” in its regulations. The guidance, titled “Referencing the Definition of ‘Devic... Read More...

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help ensure confidence in computers and automated data processing systems used in the production of medical devices.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