Devices

CDRH Proposed Guidances for FY 2027

CDRH has released its list of proposed guidances for FY 2027. The document separates the proposed guidances into three lists:

A List — priority guidance documents the Center intends to publish in FY 2027;
B List — guidance documents CDRH intends to publish as resources permit during FY 2027; and
Under Construction List — guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.

The A list contains seven final guidance topics and one draft guidance topic. The B list has three final guidance topics and two draft guidance topics. The Under Construction list has four topics.

Under A-List final guidance topics are:

• Compliance Policy Regarding Premarket and Other Requirements for Certain
NIOSH Approved Air-Purifying Respirators
• Marketing Submission and Lifecycle Management Recommendations for Artificial Intelligence-Enabled Device Software Functions
• Menstrual Products: Performance Testing & Labeling Recommendations
• Predetermined Change Control Plans for Medical Devices
• Quality Management System Information for Certain Premarket Application
Reviews
• Robotically-Assisted Surgical Devices - Premarket Submissions
• The Accreditation Scheme for Conformity Assessment (ASCA) Program

Additionally, one draft guidance is on the priority list — Generative Artificial Intelligence-Enabled Conversational Devices for Mental Disorders: Evidentiary Recommendations

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

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Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes