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 ...
STAT

An FDA pathway to clear medical devices is putting patients at risk, research suggests

The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns. For some medical ...
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Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking ...
STAT

Reforms needed for FDA’s regulation of medical devices

Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex technologies like pacemakers and infusion pumps. Given the wide range of risks and benefits, ...