The Communications and Technology subcommittee of the House of Representatives Energy and Commerce Committee held its first day of a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Tuesday. The topic of Tuesday’s hearing was “Health Information Technologies: Harnessing Wireless Innovation.” Subcommittee chairman Walden (R-OR) set the stage for the

The House of Representatives Committee on Energy and Commerce (the “Committee”) is set to hold a three-day series of hearings next week regarding regulation of medical device mobile applications. The hearings follow a March 1, 2013 letter from the Committee to Food and Drug Administration (“FDA”) Commissioner Dr. Margaret Hamburg. In the letter, the

The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion. Medtronic had argued that plaintiff’s claims were both expressly and impliedly preempted by the Medical Device Amendments to the Federal Food, Drug & Cosmetic Act (“FDCA”).
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FDA released yesterday a draft guidance entitled, “Refuse to Accept Policy for 510(k)s,” that seeks to clarify and ultimately replace existing policy documents explaining when a medical device premarket notification (510(k)) submission is administratively complete and ready for substantive review. The draft guidance comes after last month’s third renewal of the Medical Device User Fee and Modernization Act (MDUFA III) as part of the FDA Safety & Innovation Act (FDASIA), which both reauthorizes fees for medical device applications and sets performance goals for the timeliness of FDA reviews. According the FDA, the draft guidance will streamline review by “encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.”
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On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, a relabeler, or any other person who applies a label to or modifies a label on a device that will not be modified again before sale—to place a unique device identifier (“UDI”) on the label and packaging of medical devices both in plain-text and also using automatic identification and data capture (“AIDC”) technology. The UDI itself will not hold any information. Manufacturers would have to submit identification information to FDA. FDA would aggregate the manufacturer-provided information in a new Global Unique Device Identification Database (“GUDID”). This public database would allow a physician to scan or manually enter the UDI of a device at a patient’s bedside and quickly access complete information regarding the device’s key attributes and proper use instructions.

The expected benefits of the new program include:
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The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or cosmetics into the United States or are part of the import supply chain for food, drugs devices or cosmetics may wish to review the report to learn how FDA currently plans to rely on foreign posts to accomplish its mission, and what the foreign posts have accomplished so far.

FDA currently has thirteen foreign posts: three in China, two in India, four in Latin America, three in Europe, one in South Africa to serve the Sub-Saharan Africa region, and one in Jordan to serve the Middle East and North Africa. FDA has requested permission to establish an additional post in Brazil but has no current plans for additional posts. Decisions to establish foreign posts are based on the volume of imported products, the magnitude of problems associate with imported products, the value derived from leveraging activities and resources of foreign counterpart regulatory authorities, the ability of FDA to contribute to promoting U.S. public health priorities, the stability of political and security environments in the foreign country, and the political relationships and receptiveness of the foreign country to the presence of FDA staff. FDA staff are deployed to U.S. embassies or consulates. In Europe, FDA also has senior technical experts embedded in the European Medicines Agency and in the European Food Safety Authority.
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The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration (“FDA”).  The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment.  The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement.”

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Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.

In the AcneApp case, the defendants claimed that their apps could treat

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed