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The FDA Dec. 27 announced that Larry Kessler, CDRH's director of the Office of Science and Engineering Laboratories, will chair the Global Harmonization Task Force (GHTF) for medical device practices.
Australia's Therapeutic Goods Administration (TGA) extended the Dec. 1 deadline for companies remanufacturing semi-critical and noncritical single-use devices (SUDs) for reuse to comply with a ban on reused medical devices labeled for single use.
Medical laser manufacturer Biolase has had "a mixture of encouraging and concerning signs" in the first few months following a distribution agreement with Henry Schein, an analyst says.
The FDA Dec. 20 approved a first-of-its-kind device to treat babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen.
Rhein 83 must stop marketing its dental products in the U.S. because it lacks an approved premarket approval (PMA) application, an FDA warning letter said.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published a consultation paper seeking comment on a proposed hike in industry fees for medical device regulatory activities.
The Centers for Medicare & Medicaid Services (CMS) recently published information on the national coverage determination (NCD) for infrared devices, which is to be implemented Jan. 16.