JD Supra

FDA Aligns Quality Systems Regulation With International Standards

The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.
JD Supra

FDA Issues Long-Awaited Quality System Regulation Amendments

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a ...
RAPS

FDA Considers Shift on Device Quality System Regulations

A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses ...
MD&M East

Medtech Implementation of FDA’s Updated QMSR

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
RAPS

Upcoming FDA Rulemakings: Device Quality Systems, Post Approval Changes to NDAs and BLAs and More

The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system ...
The National Law Review

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

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 ...

FDA flags quality system lapses at Medline facility over device risks

The U.S. Food and Drug Administration has issued a warning letter to Medline Inc. MDLN, following an inspection that identified significant quality system violations tied to its cardiovascular device ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

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 ...
Becker's ASC

Polymicro Technologies Achieves FDA Quality System Regulation Registration, Compliance

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...
BioWorld

FDA renews plan to align quality management rules with ISO standard

The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...