News & Analysis as of

Food and Drug Administration (FDA) › Today's Popular Updates › New Guidance

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

Rothwell, Figg, Ernst & Manbeck, P.C. on

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Fox Rothschild LLP

FTC’s New Health Products Guidance

Fox Rothschild LLP on

FTC’s New Health Products Guidance...more

Hogan Lovells

FDA issues final and draft guidance on allergen labeling requirements

Hogan Lovells on

On November 29, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements. First, FDA issued a draft guidance titled Questions and Answers Regarding Food Allergens,...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

McDermott Will & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Schulte on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Laner Muchin, Ltd.

EEOC Issues Guidance On Whether Employers Can Require Employees To Receive A COVID-19 Vaccine

Laner Muchin, Ltd. on

Based on welcome news that the COVID-19 vaccine may be available to the public in the coming months, many employers are beginning to consider whether mandatory vaccinations can be incorporated into existing strategies to...more

Arnall Golden Gregory LLP

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

Arnall Golden Gregory LLP on

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

Ballard Spahr LLP

FDA Issues Guidance on Mobile Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

K&L Gates LLP

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

K&L Gates LLP on

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide