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Apple’s electrocardiograph (ECG) software for over-the-counter use, available as an app, has received a risk downgrade from the FDA to class II (special controls) as opposed to the highest-risk class III category. Read More
The FDA has failed to send Congress a required commitment letter for reauthorization of the Medical Device User Fee Act (MDUFA) by the Jan. 15 deadline. Read More
Companies located outside the European Union (EU) need to designate an EU-authorized representative if they want to sell SARS-CoV-2 in vitro diagnostic devices in EU countries, the EU’s Medical Device Coordination Group (MDCG) has advised. Read More
The number of EU Notified Bodies empowered to certify devices for a CE mark or CE-in vitro diagnostic (IVD) mark has increased by two, to 27. Read More
The FDA has outlined its latest thinking in a draft guidance on how companies should report manufacturing or supply issues that might reduce or eliminate the availability of critical equipment during a public health emergency. Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new advice to device manufacturers on how to register their products now that the country no longer relies on the EU’s CE mark. Read More
Anita Jackson, a physician in Raleigh, N.C., was indicted by a federal grand jury on Wednesday for allegedly adulterating medical devices for reuse on patients and other related charges. Read More
Medical device regulatory submissions with computational modeling evidence should include data proving the models’ credibility, the FDA advised in a new draft guidance. Read More
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a confirmation vote on Biden’s pick to lead the nation’s medical device regulator. Read More
The Centers for Medicare and Medicaid (CMS) has expanded Medicare Part B coverage of continuous glucose monitors (CGMs) and some other kinds of durable medical equipment (DME). Read More