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Medical Devices › Health IT › Food and Drug Administration (FDA)

McDermott Will & Emery

Right Time for Innovation: Apple Watch Gets Nod From FDA for Device Development Tool

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The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more

Fenwick & West LLP

Your Digital Health Regulation Questions Answered

Fenwick & West LLP on

regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...more

Knobbe Martens

Apple, Fitbit Join Pilot Program to Quicken FDA Regulatory Review

Knobbe Martens on

On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products...more

Holland & Knight LLP

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Knobbe Martens

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

Knobbe Martens on

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more

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