The GMP Letter

TGA Issues Guidance on Clinical Decision Support Software

Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods. Source: The GMP Letter

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New MDR Notified Body Designated in Finland

SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR). Source: The GMP Letter

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FDA’s Device Center Has COVID Test Regrets

The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps was a “flawed” approach. Source: The GMP Letter

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EC Agrees on Common List of COVID-19 Rapid Antigen Tests

The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize, as well as a standardized dataset to be included in test result certificates. Source: The GMP Letter

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New York Contract Manufacturer Hit for Repeat Observations

Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Source: The GMP Letter

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FDA Issues Final Guidance on New Review Path for Safer Technologies

The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Source: The GMP Letter

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TGA Investigates COVID-19 Tests and Emerging Variants

Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect emerging SARS-CoV-2 genetic variants. Source: The GMP Letter

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