![]() ![]() The FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert.The FDA conducts field examinations and analyzes samples of medical devices to ensure they comply with applicable standards and/or label requirements.Certain medical devices may need to comply with Premarket Submission requirements (Premarket Notification or Premarket Approval).What medical device requirements are verified at the time of importation?Īt the time of importation, the FDA will verify compliance with the following requirements as applicable: Please visit our radiation-emitting electronic products page for more information. If your device is also a radiation-emitting electronic product there may be additional requirements. For more information visit the Guidance for Industry and FDA Staff on Procedures for Section 513(g) Request for Information. To assist you in determining if your product is a medical device, you may visit the “Is the Product a Medical Device?” page.Īdditionally, the Federal Food, Drug, and Cosmetic Act (the Act) provides a means for obtaining the FDA’s views about the classification and the regulatory requirements that may be applicable to your particular device. If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to the FDA’s laws and regulations before, during, and after it is offered for sale or use in the United States. The term ‘‘counterfeit device’’ means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.".intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or."an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,.Personal importation of medical devices.Affirmation of Compliance codes for medical devices.How can I determine the requirements to import a medical device?.How do I obtain information on premarket submissions for specific products?.How does the FDA verify premarket submissions?.How do I obtain the manufacturer's registration and listing information?.How does the FDA verify registration and listing?.How does the FDA verify compliance with the medical device requirements?. ![]() What medical device requirements are verified at the time of importation?.Visit the Medical Devices webpage for more information. The Center for Devices and Radiological Health (CDRH) is the FDA center responsible for overseeing the medical device program. This page provides an overview of medical devices and the requirements that the FDA verifies/enforces at the time they are imported or offered for import into the United States. ![]()
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