Tag Archive: Medical Devices

Jan 11

FDA Clears Device via De Novo Process

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 …

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Feb 04

FDA Guides on General Wellness and Low Risk Devices

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 …

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Oct 14

Court Finds FDA Exceeded Authority in Device Reclassification

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. …

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Sep 24

FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices

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 …

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May 29

FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

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 …

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Jan 16

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

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 …

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Nov 11

FDA Warns Company for Marketing Medical Device

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 …

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Oct 04

FDA Targets Online Pharmacies in International Efforts

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 …

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Jul 16

FDA Proposes New Unique Identifier System for Medical Devices

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 …

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Jul 03

FDA Approves First At-Home HIV Test

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 …

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