MEDIcept Insights
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
MFDPs are products with one device function and at least one “other function,” which may or may not be considered a medical device.
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...
Electronic Submissions For Medical Devices
On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as their plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA).
FDA Publishes “Review and Update of Device Establishment Inspection Processes and Standards” Guidance
The FDA has published the final version of a guidance document it initially issued in March 2019 entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The document outlines how the agency plans to implement uniform procedures for...