Quality Assurance & Food Safety

FDA Announces Industry Training on Food Traceability Rule

The course, created in partnership with the Food Safety Preventive Controls Alliance, covers traceability recordkeeping ...
The National Law Review

FDA Finalizes FSMA Third-Party Certification User Fee Program

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 ...
Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.
MobiHealthNews

FDA opens applications for digital health pre-certification pilot program

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr.
RAPS

Medical Device Export Certificate Process Going Digital, FDA Announces

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has announced the launch of a new electronic submission process for requesting export certificates for ...
The National Law Review

FDA Launches Accredited Third-Party Certification Website

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 ...
JD Supra

FDA Exercises First Use of Import Certification Authority, Establishing New Requirements to Import Shrimp and Spices from Certain Regions in Indonesia

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced that it will begin requiring import certifications for shrimp and all spices from certain regions of Indonesia based on the ...
JD Supra

First Appearance of FDA’s Import Certification Authority

The U.S. Food and Drug Administration (FDA) has instituted an import certification requirement for shrimp and spices originating from a specific region of Indonesia. This action follows the detection ...
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
Morningstar

FDA to Require Certification on Shrimp, Spices After Radioactive Contamination

The Food and Drug Administration said Friday it will now require import certification for shrimp and spices from certain regions of Indonesia following a bout of shrimp recalls related to radioactive ...
RAPS

How to Request a Certificate of Confidentiality: FDA Unveils Draft Guidance

The US Food and Drug Administration (FDA) on Friday released draft guidance explaining how sponsors can request certificates of confidentiality (CoCs), which can prevent researchers from being ...