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  • Regulatory NewsRegulatory News

    The Future Will be Regulated: FDA Asks for More Information on Robotic Exoskeleton

    The future is here. The future will be regulated. Those are two possible conclusions from an announcement this week by Ekso Bionics, which said its robotic exoskeleton—intended to help paralyzed patients walk by augmenting their strength—must meet additional regulatory requirements put in place by the US Food and Drug Administration (FDA). At issue is the method in which Ekso Bionics' "wearable bionic suit," Ekso, is supposed to be reviewed by regulators before it is all...
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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
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    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
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    Massive Recall of Medical Devices Largest Ever Recorded by FDA

    A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA. Background: Recall Trends The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification —FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability t...
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    Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns

    Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month. Background Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, ...
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    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
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    FDA Classifies Cellulite-Reducing Device as Class II

    The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier for them to be brought to market. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices) Class II (moderate-risk devices) Class III...
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    FDA Moves Three Device Types into Class II Special Controls

    The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ensure their efficacy, safety and quality. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices), Class II (moderate risk) and Class III (high ...
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    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...
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    FDA Down-Classifies Colon, Intravascular Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation. In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devi...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...
  • FDA Loosens Regulatory Controls on Stair-Climbing Wheelchairs

    The US Food and Drug Administration (FDA) has decided to down-classify stair-climbing wheelchairs from class III to class II medical devices, meaning they will no longer require premarket approval. Background In the US, medical devices are classified according to risk. Class I medical devices represent the least risk to patients, and are often exempt from premarket regulatory oversight (so long as they meet FDA-defined standards). Class III devices represent the oppos...