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Frequently Asked Questions About Medical Devices | FDA

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices
    This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices (September 1998) Office...

Frequently Asked Questions About Medical Devices

    https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf
    3. What are examples of medical devices? Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and …

Frequently Asked Questions about the New Device …

    https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements

    Industry Frequently Asked Questions | FDA

      https://www.fda.gov/industry/fda-basics-industry/industry-frequently-asked-questions
      What protocol needs to be followed to get a medical device approved? What are the steps to prepare and submit a Premarket Notification (510 (k)) application? How can I find out …

    Exporting Medical Devices Frequently Asked Questions …

      https://www.fda.gov/medical-devices/exporting-medical-devices/exporting-medical-devices-frequently-asked-questions-faqs
      Please contact Registration and Listing with questions related to updating the registration and/or listing information using [email protected] or by calling 301-796-7400 and …

    COVID-19 Frequently Asked Questions

      https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions
      Q: Who should I contact with drug-related questions? Medical Devices Including Tests for COVID-19 Q: What types of COVID-19 tests are available? Q: What at-home over-the-counter …

    eCopy Program for Medical Device Submissions: …

      https://www.fda.gov/about-fda/ecopy-program-medical-device-submissions-frequently-asked-questions
      If you have questions regarding whether a particular dataset should be included in your submission, please contact the appropriate review division or contact the eCopy …

    Frequently Asked Questions About Combination …

      https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products
      First-aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers) Example a of product that may be cross-labeled combination …

    Frequently Asked Questions About FDA Inspections of …

      https://cacmap.fda.gov/about-fda/office-medical-device-and-radiological-health-operations-omdrho/frequently-asked-questions-about-fda-inspections-combination-products
      The Code of Federal Regulations 21 CFR 3.2 (e) defines a combination product as a product comprised of any combination of a drug and a device; a biological …

    Frequently Asked Questions about Licensing - Medical …

      https://www.dshs.texas.gov/medical-device-manufacturers-distributors/licensing-requirements-medical-device-manufacturers-distributors
      The U.S. Food and Drug Administration (FDA) is responsible for classifying all devices based upon the level of control necessary to assure the safety and effectiveness of the …



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