FDA Cracking Down on Poor Performing EUA Tests
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or...
The Final Guidance: FDA on Multiple Function Device Products
On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated. MFDPs are products with one...
Harmonization of the Quality System Regulation
In May 2018, the FDA first proposed revising its current Quality System Regulation (QSReg) to better align with ISO 13485:2016. The QSReg is the foundation rule for manufacturing safe and effective medical devices to be sold in the US, while ISO 13485 forms the basis...
FDA Restarting Domestic Inspections
On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this...