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The potential for cleanroom contamination and other deficiencies led to a Form 483 for UFP Technologies, following an FDA inspection of the company’s Chicopee, Mass. facility. Read More
PerkinElmer has gained FDA marketing authorization for its EONIS assay to simultaneously detect spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns — making it the first assay authorized by the FDA for SMA screening in newborns. Read More
Sponsors of medical devices will see increased user fees under the recently reauthorized Medical Device User Fee Amendments (MDUFA) V, but they can also look forward to more rapid submissions and approvals under a new user fee funded pilot program, according to one Washington D.C.-based regulatory attorney. Read More
Despite failing to garner U.S. approval, Australian devicemaker Artrya has nabbed regulatory approvals in both the EU and UK to market its Salix CT scan analysis software for identifying arterial plague build-up that can cause coronary artery disease. Read More
WCG Imaging has been named one of this year’s top 10 medical device testing and certification companies by MedTech Outlook, a medical technology publication. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More
Although counterfeit devices may meet the definition of a “device,” the FDA will not be treating them as such, the agency says in a final guidance released yesterday. Read More
The FDA’s Ophthalmic Devices Panel met Thursday and reached consensus that unfilled/empty eye cup and “droptainer” ophthalmic devices — currently unclassified — should be considered Class I with general controls, as recommended by the FDA. Read More