• Labeling requirements

  • Registration

  • Listing

  • Device classification

  • 510K

  • GMP inspections

  • Marketing devices

  • Post market requirements

  • Importing

  • Exporting

  • Import Alerts

  • Recalls

  • Reconditioning

  • Compliance

A medical device is defined within the Food Drug & Cosmetic Act as "...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, 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 intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's 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." 

Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing regulatory controls.

Pre-marketing controls are device and device classification specific. Pre-marketing controls for a medical device may include: clearance to market by 510(k) or approval to market by Pre-Market Approval (PMA). Post marketing controls include Device Listing, Medical Device Reporting (MDR), Establishment Registration and Quality System Compliance Inspection.

Medical Devices

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