Classification of Products as Drugs or Devices: Interpretation and Determination Process
This guidance provides clarity on how FDA classifies products as drugs or devices, focusing on the interpretation of statutory definitions and the process for obtaining formal classification determinations. It aims to help sponsors understand the key considerations in product classification and how to obtain classification determinations through the Request for Designation (RFD) process.
Recommended Actions
- Contact the Office of Combination Products (OCP) if uncertain about product classification
- When seeking device classification, prepare documentation demonstrating:
- How the product meets the device definition
- That primary intended purposes are not achieved through chemical action
- That the product is not dependent on metabolism for its primary intended purposes
- Submit a Request for Designation (RFD) if formal classification determination is needed:
- Provide complete information as required by 21 CFR 3.7
- Include justification for recommended classification
- Present all available relevant data regardless of whether it supports preferred outcome
- Consider submitting a pre-RFD for preliminary feedback before formal RFD submission
- Monitor for any changes in product characteristics or intended use that may affect classification and submit new RFD if needed
- Maintain documentation of classification determination and any subsequent changes
Key Considerations
Other considerations
- A product must meet the statutory definition of a device under section 201(h) of the FD&C Act to be classified as a device
- Key elements for device classification:
- Must be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article”
- Must not achieve its primary intended purposes through chemical action within or on the body
- Must not be dependent upon being metabolized for achieving its primary intended purposes
- Chemical action is defined as interaction at the molecular level with bodily components to mediate a bodily response
- The intended use/indication can affect product classification
- Products meeting both drug and device definitions are generally classified as devices unless they fall into special categories
Relevant Guidances
- How to Submit a Request for Designation (RFD) for Product Classification and FDA Center Assignment
- How to Submit a Pre-Request for Designation (Pre-RFD) for Product Classification and Center Assignment
Related references and norms
- 21 CFR Part 3: Product Jurisdiction
- 21 USC 321(g): Definition of Drug
- 21 USC 321(h): Definition of Device
- 21 USC 360bbb-2: Classification Procedures
Original guidance
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