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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
The Philippines FDA is advising devicemakers on documents needed as the agency transitions to new harmonized technical requirements as part of the Association of Southeast Asian Nations (ASEAN). Read More
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S. 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 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
The implant features a low, 4 mm insertion profile, so it can be inserted via the foramina openings through which nerve roots exit the spine. Read More
The devices are filled with a proprietary solution that preserves DNA and RNA at ambient temperature for at least 30 days, avoiding the need for cold shipment. Read More