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The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Read More
Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA reported. Read More
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 tariffs would hit a large number of devices such as catheters, imaging devices, anesthetic instruments and defibrillators, as well as hearing aids, pacemakers and artificial body parts. Read More