• Regulatory NewsRegulatory News

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
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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...
  • 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...
  • New China FDA Document Clarifies Device Crackdown Plan

    On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP). That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.  The Program wi...
  • FDA Reclassifies Ophthalmic Device, Issues Special Controls

    The US Food and Drug Administration (FDA) has announced that it will reclassify stainless steel scleral plugs as class II medical devices, thereby allowing the devices to be approved under the premarketing notification process [510(k)] instead of the premarket approval process. Background Scleral plugs are used to temporarily close scleral-the sclera is the white of the eye-incisions made during eye surgery. For example, during a trabeculectomy, a small circular hole is...
  • Regulators Propose Regulating CPR, ECMO Devices Less Stringently

    • 08 January 2013
    The US Food and Drug Administration (FDA) has moved to reclassify two medical device products under its class II special controls, just months after the FDA Safety and Innovation Act (FDASIA) made it easier for the agency to reclassify older, pre- Medical Device Amendments (MDA) devices. The two types of devices- external cardiac compressors , also known as chest compressors, and membrane lungs for long-term pulmonary support , also referred to as extracorporeal mem...
  • Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

    • 12 October 2012
    The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors. The remarks, reported by Bloomberg , potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new pr...
  • Legislators Slam DHHS, FDA for Special Hiring Practices

    The US Food and Drug Administration (FDA) has increased its use of special hiring authorities more than 50% in recent years to bring on staff members who can be paid more than the normal limit for federal employees, and some legislators are none too pleased at the trend. In a 14 September 2012 hearing, the Government Accountability Office (GAO), which earlier released a report on the topic , testified that the Department of Health and Human Services' (DHHS) use of speci...
  • New Draft Guidance Establishes Special Controls for Blood Access Devices

    The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis. In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis , which it said serves "as the special control for implanted blood access devices." The draft guidance follows another Federal...
  • FDA Releases Draft Guidance for Veterinary Trials

    The US Food and Drug Administration's Center for Veterinary Medicine (CVM) has released a draft guidance detailing best practices for setting active controls in animal studies used to demonstrate effectiveness of medicinal products in cats, dogs and horses. As with clinical trials, FDA said the health and general welfare of study subjects should be an active consideration when determining whether to use placebo controls or active controls, which are defined as being a "k...