Regulatory Affairs Professionals Society

This Week at FDA: Peptide dispute; clinical trial legislation, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Medical Device Network on MSN

FDA grants breakthrough device status to Teleflex’s coronary scaffold

Teleflex is currently evaluating Freesolve in the BIOMAG-III Pivotal Trial to support a future premarket approval application.
Medical Device and Diagnostic Industry (MD+DI)

FDA's AI Rulebook Wasn't Built for Agentic Devices. Now What?

Attorney Tina Hu-Rodgers explains why FDA's risk-based framework needs rethinking for agentic AI, and what medtech companies ...

Developers, not doctors, should be held accountable for generative AI medical devices, providers say

Provider groups are lobbying the Food and Drug Administration to make tech companies responsible for the safety and performance of generative AI-backed medical devices, arguing the tools’ makers are ...

The FDA Is Stepping Back From Medical AI. California Is Stepping In.

Washington is loosening oversight of clinical AI while California and other states are writing their own rules. A physician ...

Edwards wins FDA approval for tricuspid valve repair device

Edwards’ approval should “strengthen the company’s position in the large and underpenetrated transcatheter tricuspid market,” ...

FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition

Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults annually and contributes to nearly one in three in-hospital deaths DENVER, ...
RAPS

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough ...
JD Supra

FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market

The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehensive, integrated ...
Opinion

Rafferty Domnick Cunningham & Yaffa On What the FDA’s Latest Warning to Olympus Means for Medical Device Accountability

Rafferty Domnick Cunningham & Yaffa is a leading Florida law firm dedicated to advocating for victims of mass torts, medical malpractice and corporate negligence. With a track record of holding ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...