Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
Regulatory Affairs Professionals Society

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
MD&M East

Embrace FDA Regulations: Turn Medtech Compliance Into Your Competitive Edge

Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
Healio

Q&A: FDA loosens regulatory oversight for digital health innovation

It is important for primary care providers to understand new federal regulations surrounding wearables, wellness and clinical ...
MobiHealthNews

FDA clarifies the line between wellness and regulated medical devices

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...
Medscape

Only a Few AI Devices Serve Kids; Regulatory Hurdles Persist

Medical devices using AI were rarely indicated for children and were limited to a few specialties. Pediatric devices faced ...
The Lancet

Bridging the gap: aligning clinical decision support regulation with clinical practice in the era of artificial intelligence

Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous ...