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Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego agreed to pay the United States more than $33 million to resolve False Claims Act allegations that Alere knowingly sold unreliable point-of-care diagnostic testing devices to hospitals. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
In its first required inspection metrics report for 2017, the FDA found a median time of 35 days between inspection requests by the FDA to device manufacturing facilities and the beginning of inspections, and a median of five days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More
The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices. Read More
The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products. Read More
The FDA cited ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Read More
Brazil’s National Surveillance Agency released an order mapping out the specific oversight roles for federal, state and local ANVISA branches for medical devices. Read More
The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
A four-day FDA inspection of Curasan’s manufacturing facility in Frankfurt, Germany revealed a lack of manufacturing and adverse event reporting procedures. Read More
An FDA inspection of Digital Heat’s Tempe, Arizona facility conducted in December 2017 resulted in a nine-item Form 483 for failing to establish design procedures for the firm’s heated eye pad. Read More