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FDA Clears Device via De Novo Process

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On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy.  Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market. After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer.…
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FDA Guides on General Wellness and Low Risk Devices

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On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended…
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Court Finds FDA Exceeded Authority in Device Reclassification

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On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold.…
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FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices

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On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device Identification (UDI) system, finalizing the proposal first announced in July 2012. Our previous report of the proposed rule may be accessed here. In particular, the final rule will require that most medical devices distributed in the United States, with certain exceptions, bear a unique device identification on device labeling. It is also applicable to certain combination products that contain devices and to devices licensed under the Public Health Service Act. You can read the announcement here. Section 519(f) of the…
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FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

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On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The uChek Urine Analyzer is an iPhone mobile app, intended for use with Siemens and Bayer reagent strips, which allows a mobile phone to analyze the strips and determine urine analytes. You can read the letter here. In the letter, the FDA explains that urinanalysis dipsticks are cleared only when they are interpreted by a direct visual reading. Any company intending…
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FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

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On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, and parasitic causes for infectious gastroenteritis from a single sample from a patient. The FDA’s announcement may be accessed here. An inflammation of the stomach and intestines, infectious gastroenteritis is caused by certain parasites, bacteria, or viruses and can be detected by common symptoms such as diarrhea, vomiting. The condition can be a serious affliction for infants, the elderly, and…
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FDA Warns Company for Marketing Medical Device

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On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that…
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FDA Targets Online Pharmacies in International Efforts

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On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of an international campaign to protect consumers from illegal online pharmacies. Found here, the FDA’s announcement explains its involvement in the international regulatory efforts referred to as “Operation Pangea V.” The week long efforts mark the fifth annual International Internet Week of Action (“IIWA”), whereby international regulatory and law enforcement authorities engage in cooperative efforts aimed at tracking down and stopping distributors and producers of unapproved and illegal pharmaceutical products and medical devices. In addition to Operation Pangea V, the FDA recently announced…
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FDA Proposes New Unique Identifier System for Medical Devices

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On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve availability and quality of information in medical device adverse event reporting and in the event of product recalls. Under the text of the Proposed Rule, published in the Federal Register on July 10, 2012, a UDI will include a unique numeric or alphanumeric code identifying the specific device model and a production identifier, containing the current production information for the…
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FDA Approves First At-Home HIV Test

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On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to collect an oral fluid sample by first swabbing the gums. Thereafter, the sample is placed in a vial where the results will be displayed within 20 to 40 minutes. Of course, like most other at-home tests, the FDA warns that the results of the test are not definitive in nature and that additional testing in a clinical setting should be…
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