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  • China Announces Major Overhaul of Device Regulation

    On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices since the system's inception in April 2000.  The end product of six years of effort, the amended Regulations on the Supervision and Administration of Medical Devices are scheduled to go into effect on 1 June 2014, with additional implementing rules to be released over...
  • 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...
  • Chinese Provinces Get Class III Device and IVD Inspection and Approval Authority

    The China Food and Drug Administration (CFDA) has issued a notice regarding adjustments to the duties undertaken by provincial food and drug supervision and management departments, part of an effort to implement the State Council institutional reform and functional transformation plan to further the reform of administrative evaluation and approval of medical devices. The notice points out that as of 1 October 2013, the provincial Food and Drug Administration department...
  • FDA Proposes Down-Classifying Implanted Hemodialysis Devices, Releases Guidance

    A new draft guidance document just released by the US Food and Drug Administration (FDA) pertains to implanted blood access devices for hemodialysis, a type of device used as part of an artificial kidney system that FDA says it wants to down-classify from a high-risk Class III medical device to a moderate-risk Class II device regulated with special controls Background Under FDA's regulatory paradigm, nearly all Class III medical devices require a premarket approval (PMA...
  • Smart Pills, Smarter Regulation: FDA's Proposal to Simplify one Device's Path to Market

    The US Food and Drug Administration (FDA) has proposed that ingestible medical devices be classified as Class II (moderate risk) medical devices subject to the 510(k) premarket notification process and special controls, clearing the way for their wider clinical use. Background Under current federal regulations, new medical devices that have not previously been cleared by FDA are automatically considered Class III (high-risk) medical devices and require the approval of a...
  • All AEDs Would Require a Premarket Approval Under New Rule Proposed by FDA

    US regulators have proposed a new rule that would require all automated external defibrillators (AEDs) to undergo the premarket approval (PMA) process for approval due to concerns that deficient or malfunctioning devices had been a contributing factor in the deaths of some patients. Background The US Food and Drug Administration (FDA) has since 2011 been considering the reclassification of AEDs from their current Class II ( Editor's note: the devices are actually Clas...
  • 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...
  • China Announces 17 New Device Classifications

    China's State Food and Drug Administration (SFDA) issued a notice to the provinces and autonomous regions on 10 December 2012 announcing the classification of 17 medical devices based on expert advice provided to the SFDA. Two products are to be regulated as Class III (high-risk) medical devices: an ultrasound tumor therapy system and a diagnostic imaging device for the skin.  An ultrasound breast imaging diagnostic device and medical imaging software were among...
  • Indian Regulators Finalize Recall System Requirements

    Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and biological drugs, bringing the country much more closely in line with the recall standards of most established regulatory authorities. The draft guideline , released in late October, was available for public comment for 15 days. A side-by-side analysis of the draft and final guide...
  • High Risk Devices to be Excluded From EU Mutual Recognition Agreement

    High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition Agreement (MRA) concluded between Australia and the EU. All Class III-high risk-medical devices are excluded from the MRA until the appropriate confidence building activities have been undertaken between the two parties. Also excluded from the amended MRA are certain medical ...
  • Hospira Initiates Class I Recall for Touchscreen, Software Issues

    • 30 October 2012
    Medical device manufacturer Hospira has issued a voluntary Class I recall in the US for its Symbiq Infusion system after being made aware that the device's LCD touch screens were occasionally unresponsive, causing errors, treatment delays, incorrect treatment or treatment interruptions. The class of devices is used to deliver exact amounts of medication to patients, and Hospira markets it as a method to achieve compliance with good clinical practice guidelines. In ...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
    The Drug Enforcement Administration (DEA) has placed methylone, a powerful stimulant and psychoactive drug most notorious for its presence in bath salts, into its Schedule I of highly restricted drugs with no accepted medical use within the US. The drug is chemically similar to other drugs like Ecstasy (MDMA), which has been a Schedule I drug under the Controlled Substances Act (CSA) since 1985. DEA's actions would act to put into place a more permanent solution, o...