News & Analysis as of

Medical Devices › General Wellness Devices

Loeb & Loeb LLP

Illuminating the Risks: FDA Clearance Does Not Fully Shield Health & Wellness Devices from Advertising Scrutiny

Loeb & Loeb LLP on

The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more

Wilson Sonsini Goodrich & Rosati

Electronic Gaming Podcast | Games as Medical Devices and Government Regulation

Wilson Sonsini Goodrich & Rosati on

Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....more

McDermott Will & Schulte

FDA 2016 Year in Review

McDermott Will & Schulte on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

Morgan Lewis

FDA Uses Summer to Issue Numerous Device Guidance Documents

Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2016

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

Well, Well, Well – What Do We Have Here: FDA Eases Up On Regulating General Wellness Products

Arnall Golden Gregory LLP on

The Food and Drug Administration has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final...more

King & Spalding

FDA Finalizes Wellness Product Guidance

King & Spalding on

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

Cooley LLP

Blog: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

Cooley LLP on

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more

McDermott Will & Schulte

FDA Finalizes Guidance on Low Risk General Wellness Devices

McDermott Will & Schulte on

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory...more

9 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