We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
Specification developer Blue Belt Technologies failed to submit medical device reports (MDRs) for injuries associated with Smith & Nephew’s Navio tissue protector and bone pins, according to a Form 483 the firm received following an FDA inspection of its Pittsburgh, Pennsylvania facility. Read More
Inadequate design validation and risk analysis tripped up hearing aid maker Magnatone Hearing Aid Corp., during an FDA inspection of its Casselberry, Florida facility. Read More
Inadequate procedures for receiving, reviewing and evaluating complaints as well as other quality system shortfalls were observed during an FDA inspection of contract manufacturer LH Medical’s Fort Wayne, Indiana facility. Read More
The FDA spelled out best practices for the use of patient-reported outcome (PRO) instruments in the development, evaluation, and surveillance of medical devices, in a newly released draft guidance. Read More
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More
In further Brexit fallout, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) said that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023. Read More
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body. Read More
Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the agency. Read More