The GMP Letter
FDA Continues to Target Unapproved COVID-19 Tests
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Source: The GMP Letter
Read MoreEU Clarifies Expectations for Remote Audits
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Source: The GMP Letter
Read MoreFDA Tells Devicemakers Denied an Export Permit How to Reapply
Device manufacturers that have been denied a Certificate to Foreign Government (CFG) to export a product may file for a review of the decision in a process laid out in a new FDA guidance. Source: The GMP Letter
Read MoreMedTech Europe: Class D Diagnostics Vulnerable Under EU IVDR
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Source: The GMP Letter
Read MoreTGA Rolls Out New Regulations on Personalized Medical Devices
Australia’s Therapeutic Goods Administration (TGA) released new regulatory requirements for personalized medical devices that will go into effect on Feb. 25, 2021. Source: The GMP Letter
Read MoreGermany’s TUV SUD Issues First IVDR Certificate
Munich, Germany-based notified body TÜV SÜD has issued its first certificate for an in vitro medical device under the EU’s new In Vitro Medical Device Regulation (IVDR), marking the first IVDR certificate worldwide. Source: The GMP Letter
Read MoreProfessional Interactions Key to FDA Inspections, Say Former Officials
When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Source: The GMP Letter
Read MoreFDA Offers Guidance on Safety Info for Electromagnetic Devices
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Source: The GMP Letter
Read MoreFDA’s Policy for Lab-Developed Tests Leaves Unanswered Questions
The FDA attempted to provide clarity on an HHS announcement over the summer that it would no longer require premarket reviews of laboratory-developed tests (LDTs), including LDTs for COVID-19, but the attempt just muddied the water further, according to attorneys at Ropes & Gray. Source: The GMP Letter
Read MoreCanada Issues Guidance on Using UV Radiation for Decontaminating Devices
Health Canada has issued new guidance for devicemakers on requirements for ultraviolet radiation equipment used to decontaminate devices. Source: The GMP Letter
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