Manufacturers, Draft Guidance, Health Care Providers

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

Searcy Denney Scarola Barnhart & Shipley on 8/26/2024

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

Dechert LLP on 11/3/2023

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

FDA Issues New Draft Guidance for Unapproved Use Communications

Troutman Pepper on 10/26/2023

On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

FDA Issues Guidance Regarding Alcohol-Based Hand Sanitizers For COVID-19 Prevention

Seyfarth Shaw LLP on 4/3/2020

In response to the shortage of alcohol-based hand sanitizer due to the COVID-19 pandemic, distillers and other entities that manufacture alcohol have stepped in to assist in the production of alcohol-based hand sanitizer. On...more

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on 3/27/2020

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing

Mintz - Health Care Viewpoints on 12/21/2018

On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 11/30/2018

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on 10/19/2018

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper on 1/31/2017

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

Snell & Wilmer on 7/23/2014

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

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