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…
EU 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
FDA 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…
MedTech 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…
TGA 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
Germany’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…
Professional 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…
FDA 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…
FDA’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…
Canada 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