Daniel Wittenberg

Daniel Wittenberg

Snell & Wilmer

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FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

7/22/2015 - Exemptions FDA FFDCA Final Guidance Medical Devices

Adopting a Safety Policy and Assembling a Safety Team

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more

6/11/2015 - Best Management Practices Life Sciences Manufacturers Medical Devices Product Defects Product Labels Product Packaging Product Recalls Product Safety Labels Safety Precautions Safety Training Technology

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

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

7/23/2014 - Draft Guidance Drug Manufacturers FDA Healthcare Providers Internet Manufacturers Marketing Medical Devices Prescription Drugs Social Networks Twitter

FDA Issues New Draft Guidance on Medical Device Data Systems

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical...more

6/25/2014 - EHR FDA Medical Devices PHI

Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a...more

6/5/2014 - Drug Manufacturers FDA Healthcare

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