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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 Proposes Making it Easier to Classify and Reclassify Medical Devices According to Risk

    A new regulation proposed today by the US Food and Drug Administration (FDA) would change the procedures by which it classifies and reclassifies medical devices according to their perceived risk, making it much easier for FDA to make changes based on new or changing information. Background The proposed regulation was called for by 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 give...
  • 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...
  • China Classifies, Reclassifies Dozens of Medical Devices After Review

    Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices. Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices.  Examples of new classif...
  • Health Canada Releases New GMP Inspection Guidance

    New guidance released on 11 September by Health Canada makes changes to the way the agency classifies observations made during the course of a good manufacturing practice (GMP) inspection. The new system is intended to ensure uniformity between various regulatory agencies in Canada, the guidance explains. Inspection findings are at a high level segregated into one of two categories: compliant or noncompliant with the Food and Drugs Act . As is the case in other coun...
  • Canada: Health Canada To Develop Guidance Clarifying Drug/Device Classification

    Health Canada is announcing a notice pertaining to the categorization of Therapeutic Products. The notice indicates a product's mode of action will not necessarily determine whether a product is a medical device or a drug, and previous decisions will not be a litmus test for future product classification. In order to enhance transparency, Health Canada intends to develop guidance that will clarify what factor will determine whether a product will be classified as a dru...
  • EMA Releases Paper on Advanced Therapies to Assist Sponsors

    The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...
  • New Medical Device Guidance on Information Requests Released by FDA

    The US Food and Drug Administration (FDA) released two new guidance documents covering Section 513(g) requests for information issued under the Federal Food, Drug and Cosmetic Act (FD&C Act). Section 513(g) is the means by which industry may obtain FDA's views about the classification and the regulatory requirements for medical devices. "This guidance describes procedures for the submission, FDA review, and FDA response to requests for information with respect to t...
  • 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...
  • CDRH Releases Project Statuses for 26 Device Classes

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an updated schedule describing the classification timelines of 26 device classes. The 17 February release of the schedule is a part of CDRH's 515 Program Initiative, which is part of CDRH's overall Transparency Initiative . The 515 Program is named after Section 515 of the Federal Food, Drug and Cosmetic Act (FD&C Act) which covers the reclassification o...
  • FDA Releases New Draft Guidance on Medical Device Classification Product Codes

    The FDA released new draft guidance for industry on Tuesday titled, Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes . Classification product codes are used by FDA to help identify, track, and reference medical device types. They are standardized alphanumeric strings used to quickly identify the product's characteristics, device class, and predicate devices. The purpose of the draft guidance is to educat...