On September 28, 2022, FDA released two proposed rules aimed at amending some sections of its current regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Federal Policy for the Protection of Human Subjects—also known as the...
When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...
In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design principles and approaches used to develop relevant documents for clinical...
Makers of cardiovascular devices can navigate the dreaded “valley of death” for their unmarketed products by playing in an upcoming pilot program from the U.S. Food and Drug Administration (FDA) that will allow for earlier and more frequent engagement between...
The Medical Device Coordination Group released in August a 19-point action plan that the MDCG says will make sure medical products can be certified to the E.U.’s new MDR and IVDR regulations within prescribed transition time frames. The Position Paper, MDCG 2022-14,...
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on Oct. 6 told medical device manufacturers that beginning next month they must send post-market vigilance reports via the MHRA’s “new” Manufacturer's On-line Reporting Environment (MORE) portal. As...
Makers of medical devices will have to submit 510(k)s to the Food and Drug Administration electronically beginning in October 2023, a new guidance document from the U.S. agency says. Through the 16-page guidance dated Sept. 22, manufacturers are being forcibly nudged...
Manufacturers have been given direction by the U.S. Food and Drug Administration on how they can best comply with the agency’s current good manufacturing practice (CGMP) requirements for combination drug/device products. In a Final Notice published in the Federal...
Manufacturers would apply a risk-based approach to validating software used in quality systems and the production of medical devices under a new proposed guidance document from the U.S. Food and Drug Administration (FDA). Dated Sept. 13, the 25-page draft doc,...
The Food and Drug Administration (FDA) says in a Sept. 7 guidance document that it’s offering templates for diagnostics developers to use as they seek Emergency Use Authorization (EUA) from the U.S. agency for monkeypox diagnostic tests. The templates, which offer...