Close
Loading the player ...
Download Avery Dennison compliance certificates
Close
Loading the player ...
Medical Devices Flow Chart
Close
Loading the player ...
FDA on Medical Devices
Close
Loading the player ...
FDA Medical Device Product Classification Database
Close
Loading the player ...
21 CFR 800 - 1299

Medical Devices

 

Medical device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

  1. recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, or
  2. 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
  3. 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 its primary intended purposes.

Note that the definition is broad and includes components. Medical devices can range from simple devices like bandages and tongue depressors to high-tech equipment like pacemakers. Medical devices also include in vitro diagnostic products, such as medical lab equipment, reagents, and test kits.

 

Medical devices are categorized into Class I, II, or III.

Class I Class II Class III
  • A medical device relevant to Avery Dennison would likely be a Class I or Class II device. For instance, bandages are usually Class I and medical bags are usually Class I or Class II, depending on the application.
  • Premarket Notification (510(k)) is required for Class I and II devices, unless exempt. Many Class I and II devices are exempt, subject to limitations. When a 510(k) is required, an FDA letter declaring the device substantially equivalent to another legally marketed device must be received before the device can be marketed.
  • Premarket Approval (PMA) is required for Class III devices, and is a more extensive process than premarket notification.

 

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments annually with the FDA and provide a listing of devices.

Facilities and methods related to designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices must follow FDA's Quality System Regulation (QS)/Good Manufacturing Practices (GMP).

Other requirements for medical devices include requirements for labeling, reporting incidents, post-market surveillance, device tracking, and import and export. See the Medical Devices Flow Chart for more detailed explanation of medical device requirements.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.