JD Supra

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration Certificates

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective ...
JD Supra

Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?

Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking ...