• 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...
  • 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...
  • 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    A new draft guidance document just released by the US Food and Drug Administration (FDA) pertains to implanted blood access devices for hemodialysis, a type of device used as part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...
  • 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...
  • EMA Updates Its Fee Structure Guidance

    The European Medicines Agency (EMA) has released a revised set of rules regarding the fees payable to the agency for the submission of medicinal products and the maintenance of regulatory activities. The rules, released 24 August 2012, include four primary revisions to the existing version, said EMA. The first is a clarification regarding the definition of type II quality variations. Type II variations are defined by EMA as " major variations " that are likely to have...
  • 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...
  • EU:European Commission Opens Review of Variations Guidance

    The European Commission has opened a public consultation on proposed changes to the current guidance on making changes to the terms of approved marketing authorizations, otherwise known as the "Variations Regulation." The document takes into account scientific and technical progress since the entry into force of guidelines in January 2010 and addresses an update required by the implementation of the new Pharmacovigilance legislation, which will enter into force in July...
  • FDA Establishes Class II Controls for Full Field Mammography System

    The US Food and Drug Administration (FDA) released new guidance on 27 March establishing Class II Special Controls for full field digital mammography systems (FFDMS), bringing the device class under the 510(k) approval pathway. The guidance, Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System , includes advice on the evaluating risks to human health, electrical safety precautions, biocompatibility, phy...
  • Near Infrared Brain Hematoma Detectors Classified as Class II Medical Devices by FDA

    The US Food and Drug Administration (FDA) issued a final rule classifying Near Infrared (NIR) Brain Hematoma Detectors as class II medical devices requiring special controls on 22 March. The rule is in response to a petition issued by InfraScan Inc., which asked FDA to classify its Infrascanner Model 1000 device-previously found by FDA to be class III-as a class II device instead. FDA agreed with their assessment, and identified the inherent risks of the device and miti...
  • FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

    The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes will streamline the clearance pathway for medical devices. "Currently, these tests are Class III (high-risk) devices that require the more rigorous pre-market approval application," said FDA in a statement released on their website 16 March 2012. FDA is proposing to downclass...
  • ADHD Drugs Remain in Short Supply

    A shortage of a medication used to treat attention deficit hyperactive disorder (ADHD) shows little sign of abating as the US Drug Enforcement Administration (DEA) continues to regulate the amphetamine salts that act as the drug's active pharmaceutical ingredient (API). The DEA controls the supply of the amphetamine salts via a manufacturing quota system, and authorizes certain amounts of the amphetamine salts to be distributed based on what the agency determines to be t...