Contact

MEDIcept
200 Homer Ave
Ashland, MA 01721

Phone
508-231-8842

Name*
First Last
Address
City/State
Email*
Phone
Comments
Security

IVDR: What You Need to Know about Europe’s Changing IVD Market

The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this directive, all products of all classes that stay on the market after May 26, 2022 must be reassessed for IVDR compliance to ensure that those products are fit for purpose and safe to use. There is no automatic pass granted based on the...

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 life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.” Since February 4, 2020, FDA has approved 204 Covid-19 tests...

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 device function and at least one “other function,” which may or may not be considered a medical device—for example, a product has an additional software function like patient management. The term “software,” as it relates to a...