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Healthcare › Food and Drug Administration Safety and Innovation Act

Alston & Bird

A&B Healthcare Week In Review, September 2015

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On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more

K&L Gates LLP

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

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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

King & Spalding

FDA Holds Webinar Discussing Final Guidance on Custom Device Exemptions - Restrictions Loosened but Exemption Remains Narrow

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On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration...more

Mintz - Health Care Viewpoints

Regulation of Health IT: A Risk-Based Approach

Mintz - Health Care Viewpoints on

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

Foley & Lardner LLP

Finally…FDASIA Health IT Regulation Report Released

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The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

Fenwick & West Life Sciences Group

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Fenwick & West Life Sciences Group on

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

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