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FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

Expedite Med Device Approval with FDA’s New Program

Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.

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How FDA Food Supply Data Supports COVID-19 Vaccine Distribution

In the latest FDA Voices post, Dr. Stephen Hahn and Frank Yiannas, M.P.H. discuss how the new data analysis tool, 21 FORWARD, is helping food and agriculture workers receive vaccines.

Joyce Fassl, Editor-in-Chief, Profood World.

Advanced Automation Tools May Be Just the Panacea Our Industry Needs

Industry stakeholders work toward operational improvements and worker safety, while labor unions fight for workers’ rights during this unparalleled era. But automation remains a key aspect of a winning outcome.

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FDA Dec. Meeting: Drug Supply Chain Security Act Pilot Project Program

FDA will host a virtual public meeting Dec. 8 and 9, 2020.

The FDA’s CORE Network will use this Investigation Table to communicate about outbreaks from beginning to end through weekly updates.

CORE Outbreak Investigation Table Issued

The FDA’s new tool will share information on foodborne illness outbreak investigations through weekly updates even in early stages.

The reported prevalence of sesame allergies in the U.S. population has increased. Allergic reactions to sesame may occur from products with undeclared sesame ingredients.

FDA Guidance on Voluntary Disclosure of Sesame

This draft guidance for the industry includes sesame when added as flavoring or as spice.

Alignment determinations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits.

Voluntary Pilot Program for Third-Party Food Safety Standards

The FDA is launching this program to evaluate third-party food safety standards, meeting another milestone in the new era of smarter food safety.