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Reports of a vulnerability in the Blackberry operating system used in certain medical devices and device manufacturing equipment as well in pharmaceutical manufacturing equipment has prompted the FDA to issue a cybersecurity alert. Read More
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance that clarifies when certifications for high-risk Class D in vitro diagnostics would need to involve an expert review panel. Read More
The FDA’s long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device was supposed to provide clarity, but there are still unanswered questions, according to attorneys at Ropes & Gray. Read More
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021. Read More
An FDA advisory committee concluded that Keystone Heart’s Triguard 3 cerebral embolic protection device is not substantially equivalent to a predicate device. Read More
The EU’s Medical Device Coordination Group (MDCG) released guidance on evaluating the performance of in vitro diagnostics that detect SARS-CoV-2 nucleic acid, antigens and that quantify antibodies. Read More
Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More
Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey. Read More
The FDA issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. Read More
The FDA expects to collect almost $263 million in user fees from devicemakers in fiscal year 2022 and it is increasing registration and application fees across the board. Read More
The FDA has accredited 68 testing laboratories so far under its Accreditation Scheme for Conformity Assessment (ASCA) pilot, in which testing labs may be accredited by accreditation bodies to assess the conformance of a device with certain FDA-recognized standards. Read More