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Food and Drug Administration (FDA) › Risk Management › Final Rules

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

Mintz - Health Care Viewpoints on

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Morgan Lewis - Well Done

Navigating FDA from 2024 into 2025 Human Foods Program

Morgan Lewis - Well Done on

FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2025

Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Issues Final Risk Management Rules For TCE, PCE, And CTC: The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

Gardner Law on

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

King & Spalding on

On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

Jones Day on

Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more

K&L Gates LLP

FDA Releases Traceability Final Rule

K&L Gates LLP on

The U.S. Food and Drug Administration (FDA) released its final rule on the traceability of high-risk foods on 21 November 2022. The regulations, to be codified at 21 C.F.R. part 1, subpart S (titled “Additional Traceability...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2016

Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more

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