CDRH shares regulatory guidance priorities for the coming 12 months

Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two ...
MedTech Dive

How the FDA’s crackdown on cybersecurity affects medtech firms

MedSec CEO Michelle Jump spoke with MedTech Dive at AdvaMed’s annual meeting about the FDA’s shift from a “carrot” to a ...
Targeted Oncology

Defining Survival: FDA's New Requirements for Oncology Trial Design

Harpreet Singh, MD, former director of the FDA's Division of Oncology 2 and chief medical officer of Precision for Medicine, ...
Targeted Oncology

FDA Guidance: Overall Survival as a Safety End Point, Not Just Efficacy

Harpreet Singh, MD, former director of the FDA's Division of Oncology 2 and chief medical officer of Precision for Medicine, discusses the FDA's draft guidance on the use of overall survival (OS) as ...
Becker's Hospital Review

The Health IT Most Likely to be Subjected to FDA Regulation

During a Sept. 4 meeting of the Office of the National Coordinator for Health IT’s HIT Policy Committee, members of a subgroup discussed the health IT likely to be subject to Food and Drug ...
WV MetroNews

Lawmakers hear testimony over potential regulations on vaping products

Abboud did advocate for alternatives to matching the FDA’s regulatory system, stating that studies show vaping products help ...
St. Louis Post-Dispatch

FDA proposes regulation of e-cigarettes

The Food and Drug Administration will offer a 75-day period to comment on the proposal, which is not final. The agency will evaluate those comments before issuing a final rule but there’s no timetable ...
MobiHealthNews

FDA medical app regulation and the art of intended use

With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of ...
MobiHealthNews

Commentary: FDA’s website has wrong information about the scope of its software regulation — and that's a big problem

The guidance sets forth FDA’s 2015 policy on when mobile medical applications qualified as medical devices. But in 2016 the 21st Century Cures Act changed fundamentally the scope of FDA’s oversight of ...