RAPS

Experts: Strong design controls are key to FDA device approval

LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
RAPS

Updated: FDA Flags Lack of Design Controls at Mibo Medical Group

The US Food and Drug Administration (FDA) last November sent a letter to Texas-based Mibo Medical Group to say that the firm addressed the violations in a warning letter from December 2018. "Future ...
Medical Device and Diagnostic Industry (MD+DI)

From Silos to Integration: FDA’s Framework for Digital & Intelligent Devices

Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...
JD Supra

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical ...
JD Supra

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
BioSpace

Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA

After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to ...