Michael Ryan

Michael Ryan

McDermott Will & Emery

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FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon...more

8/10/2016 - 510(k) RTA Draft Guidance FDA Medical Devices Modification Software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 - FDA Final Guidance General Wellness Devices Medical Devices

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized medical device data from device manufacturers...more

6/22/2016 - Draft Guidance FDA Manufacturers Mobile Health Apps Patient Rights Right of Access

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

4/21/2016 - Breach Notification Rule FDCA FTC HIPAA Mobile Health Apps

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FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

1/28/2016 - Cybersecurity Draft Guidance FDA Health Care Providers Health Information Technologies Medical Devices Patient Safety Risk Management

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

9/10/2015 - Biologics Biosimilars Comment Period Draft Guidance Drug Safety FDA Federal Register Pharmaceutical Industry Prescription Drugs Proposed Regulation Public Health Service Act World Health Organization

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 FDA Investigational Device Exemptions Medical Devices Premarket Approval Applications

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

3/26/2015 - Clinical Trials FDA HHS Informed Consent Medical Research Pharmaceutical Industry Scientific Research

Pomegranate Health Benefit Claims Were False, Misleading - POM Wonderful, LLC, et al. v. Federal Trade Commission

In an opinion addressing the amount and type of scientific evidence required to substantiate disease treatment and prevention claims, the U.S. Court of Appeals for the District of Columbia upheld the Federal Trade...more

3/19/2015 - Advertising Clinical Trials False Advertising FTC POM Wonderful

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 - FDA Final Guidance 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 FDA Medical Device Accessories Medical Devices

Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests

Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s...more

8/7/2014 - CLIA Clinical Laboratories FDA Laboratory Developed Tests

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

6/26/2014 - Digital Health Enforcement Exemptions FCC FDA Healthcare ONC

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

6/18/2014 - Draft Guidance FDA Health Safety Pharmaceutical Industry Reporting Requirements

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 FDA Health Information Technologies Medical Devices ONC

HHS and GAO Reports Highlight Need to Address Drug Shortages

Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively, focus on the impact of prescription drug shortages, their potential causes...more

3/26/2014 - FDA GAO HHS Pharmaceutical Industry Prescription Drugs

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 - FDA Medical Devices Off-Label Use Pharmaceutical Industry Prescription Drugs

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

1/29/2014 - Biologics FDA Internet Marketing Prescription Drugs

New Law Extends Federal Oversight of Compounding Pharmacies, Establishes National Drug Track-and-Trace Requirements

On November 27, 2013, President Obama signed the Drug Quality and Security Act (the Act) (Public Law No. 113-54) into law. The Act addresses two hot-button issues relating to marketed drug products: the extent of federal...more

1/22/2014 - Drug Compounding FDA Pharmaceutical Industry Pharmacies Prescription Drugs

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

5/7/2013 - Biosimilars FDA Fees Meet and Confer Sponsors

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