Michael Ryan on Medical Devices

CMS, FDA Parallel Review Program for Medical Devices Extended Indefinitely

On October 24, 2016, the US Food and Drug Administration and the Centers for Medicare & Medicaid Services announced the full implementation and indefinite extension of the Program for Parallel Review of Medical Devices (the...more

10/31/2016 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medicaid , Medical Devices , Medicare

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

9/20/2016 / Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Product Labels , Unique Device Identifiers

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon...more

8/10/2016 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Modification , Software

FDA Finalizes Guidance on Low Risk General Wellness Devices

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

8/4/2016 / Final Guidance , Food and Drug Administration (FDA) , General Wellness Devices , Medical Devices

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

2/18/2016 / Big Data , Biologics , Center for Drug Evaluation and Research (CDER) , Databases , Electronic Medical Records , Food and Drug Administration (FDA) , Medical Devices , Prescription Drugs

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

1/28/2016 / Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Health Information Technologies , Medical Devices , Patient Safety , Risk Management

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

4/30/2015 / Clinical Trials , Food and Drug Administration (FDA) , Investigational Device Exemptions , Medical Devices , Premarket Approval Applications

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

2/12/2015 / Final Guidance , Food and Drug Administration (FDA) , Healthcare , Medical Device Accessories , Medical Devices

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

2/5/2015 / Draft Guidance , Food and Drug Administration (FDA) , Medical Device Accessories , Medical Devices

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

4/10/2014 / FCC , Food and Drug Administration (FDA) , Health Information Technologies , Medical Devices , ONC

FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.” The draft guidance,...more

3/10/2014 / Food and Drug Administration (FDA) , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs

Michael Ryan

McDermott Will & Schulte

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