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  2. Medical Device User Fee and Modernization Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_User_Fee...

    FDA Amendments Act of 2007: Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017

  3. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.

  4. Food and Drug Administration Safety and Innovation Act

    en.wikipedia.org/wiki/Food_and_Drug...

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  5. Food and Drug Administration Amendments Act of 2007

    en.wikipedia.org/wiki/Food_and_Drug...

    Title III requires applications for a humanitarian device exemption, an application for premarket approval of a medical device, or a product development protocol for a medical device to include, if available, a description of any pediatric subpopulations that suffer from the disease that the device is intended for, and the number of affected ...

  6. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Medical device has insufficient information to provide reasonable assurance of the safety and effectiveness of the device. Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device.

  7. CFR - Code of Federal Regulations Title 21

    highline.huffingtonpost.com/miracleindustry/...

    CHAPTER I­­FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER D­­DRUGS FOR HUMAN USE PART 314 ­­ APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Subpart B­­Applications Sec. 314.50 Content and format of an application.

  8. Independent reviewer - Wikipedia

    en.wikipedia.org/wiki/Independent_reviewer

    The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...

  9. Single use medical device reprocessing - Wikipedia

    en.wikipedia.org/wiki/Single_Use_Medical_Device...

    The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...