MEDIcept Insights
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
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...
Risky Business: FDA Trots Out Risk-Based Framework For Validating Software For Quality Systems, Device Production
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,...
New FDA Guidance Doc Lays Bare Process For Requesting EUAs For Monkeypox Diagnostics
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...
MDCG Urges Compliance To EU’s MDR/IVDR In 19-Point Action Plan
The Medical Device Coordination Group (MDCG) this week urged manufacturers to make sure they’re in “timely compliance” with the EU’s MDR and IVDR regulations to help stave off product shortages. In a position paper released on Aug. 30, “Transition to the MDR and IVDR:...
U.K. MHRA Gives Device Makers More Time To Comply With New Reg Framework
As the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) transitions to a new post-Brexit regulatory framework, it has announced that medtech companies will get extra time to comply with regulations. This is good news for the industry, which has faced...
Guidance on IVDR Significant Changes
Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...