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Home » Newsletters » The GMP Letter

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The GMP Letter

The GMP Letter Subscribe

February 2021

No. 493
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Full Issue of The GMP Letter in PDF Format

February 4, 2021
Download and view the full issue. Read More

FDA Gears Up to Launch Accreditation Scheme for Conformity Assessment

February 4, 2021
The FDA’s Center for Devices and Radiological Health (CDRH) is getting ready to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the conformance of a device with FDA-recognized standards. Read More

FDA Unveils Action Plan for Artificial Intelligence/Machine Learning Software

February 4, 2021
The FDA has released a new action plan that outlines a potential approach to premarket reviews for artificial intelligence (AI) and machine learning-(ML) software modifications. Read More

Health Canada Issues New Guidance on Postmarket Reports

February 4, 2021
Health Canada has issued new guidance for devicemakers on submitting “summary reports” and conducting issue-related analyses of safety and effectiveness for devices approved for marketing in Canada — two requirements recently added to Canadian regulations. Read More

MHRA Issues Guidance on Stand-Alone Software

February 4, 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance that clarifies the deadlines for stand-alone software that must carry the UK conformity assessment mark (UKCA) for applications regulated as medical devices. Read More

Repeat Observations Dog Arizona Mask Maker

February 4, 2021
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix, Arizona facility. Read More

Medtronic Hit for Failing to Properly Investigate Reports of Device Failure

February 4, 2021
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More

TGA Investigates COVID-19 Tests and Emerging Variants

February 4, 2021
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. Read More

FDA Issues Final Guidance on New Review Path for Safer Technologies

February 4, 2021
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. Read More

New York Contract Manufacturer Hit for Repeat Observations

February 4, 2021
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. Read More

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