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Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

A Brief Overview of the Case Law Regarding "Failure to Train" Claims - And Its Implications for Medical Device Manufacturers

In recent years, causes of action for “failure to train,” or allegations predicated on a duty to train, have been on the rise in cases against medical device manufacturers. Historically, however, such claims and allegations...more

FDA Issues Draft Guidance on Custom Devices

Exemption for Custom Devices Remains Narrow - On January 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Custom Device Exemption. The draft guidance...more

FDA’s Message to Medical Device Company: Stop

The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious...more

Offering health care solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps

Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders...more

FDA Submits Final Guidance on Mobile Medical Apps

Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

FDA Letter to Mobile App Developer Signals Regulatory Scheme

Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more

FDA Delivers Its First Mobile Medical App Inquiry

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. ...more

Product Liability Update - April 2013

In This Issue: - United States Supreme Court Holds Class Certification Improper Absent Showing Plaintiffs’ Damages Can Be Measured on a Classwide Basis through Use of a Common Methodology that Is Consistent with...more

Howard v. Zimmer: Negligence Per Se Based on Violations of the FDCA—Blurring the Line Between Parallel Claims and Preemption

Last week in Howard v. Zimmer, — P.3d —, 2013 WL 1130759 (Okla. 2013), the Oklahoma Supreme Court held that a plaintiff can assert a negligence per se claim against a medical device manufacturer based on the manufacturer’s...more

FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices....more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

IRS Releases Final Rule on Medical Device Tax

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

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