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 ...
Fox Business

1,300 Chinese medical suppliers to US use bogus registration data

More than 1,300 Chinese medical-device companies that registered to sell protective gear and other equipment in the U.S. during the coronavirus pandemic listed as their American representative a ...
Food Safety News

FDA amends facility registration rule to limit fraud, ease inspections

The U.S. Food and Drug Administration is amending its final rule on the registration of food facilities to require additional information from registrants. The goals are to reduce potential fraud and ...
Becker's Hospital Review

Internal FDA database hides dangerous device malfunctions from physicians, KHN report finds

The FDA permits some devicemakers to file reports on device-related injuries and malfunctions in a discreet database that is not accessible to physicians or the general public, according to an ...
Fleet Owner

FDA guide helps food facilities meet registration requirements

Learn how the FDA's Small Entity Compliance Guide can help food facilities meet their FD&C Act registration requirements. The US Food and Drug Administration has issued a Small Entity Compliance Guide ...
Business Insider

FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

SILVER SPRING, Md., Jan. 29, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced the launch of an interactive database that will offer a wealth of critical information about ...
JD Supra

FDA delays UDI database enforcement for low-risk devices

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...
CBS News

FDA database that tracks heart device harms may miss red flags, safety experts warn

Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost ...
Becker's Hospital Review

FDA releases database of 343 authorized AI-powered medical devices

The FDA has released a database of artificial intelligence-powered medical devices authorized for use. The database contains publicly available data on AI and machine learning-enabled devices. The FDA ...
The National Law Review

FDA Suspends Topway/Kazy’s Gourmet Facility Registration

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Convenience Store News

FDA Creates Database for Legally Marketed Tobacco Products

Entries include information on each product, their manufacturer and date of the agency's approval. New tobacco products that received marketing authorization through one of FDA's three pathways to ...