References to Section 201(h) of the FD&C Act Following the Safeguarding Therapeutics Act
This guidance clarifies how FDA interprets references to section 201(h) of the FD&C Act following the Safeguarding Therapeutics Act, which added a new definition for counterfeit device and redesignated the existing device definition. The guidance aims to provide clarity on how to reference these terms in regulatory documents, communications, and other public documents.
What You Need to Know? 👇
What is the purpose of FDA’s guidance on referencing the definition of “device” in the FD&C Act?
The guidance promotes clarity and consistency when referencing “device” and “counterfeit device” definitions following amendments made by the Safeguarding Therapeutics Act, which redesignated the device definition to section 201(h)(1).
How did the Safeguarding Therapeutics Act change the device definition in the FD&C Act?
The Act redesignated the existing “device” definition as paragraph (1) of section 201(h) and added a new “counterfeit device” definition as paragraph (2). The actual device definition itself remained unchanged.
Should existing references to section 201(h) be updated after the Safeguarding Therapeutics Act?
No immediate updates are required. FDA interprets existing references to section 201(h) as referring to the device definition, which remains within subsection (h), just now specifically at paragraph (1).
Do FDA enforcement policies for devices apply to counterfeit devices?
No. FDA’s enforcement policies that describe intent not to enforce certain FD&C Act requirements for devices do not apply to counterfeit devices, as they would generally violate the Act.
When should stakeholders reference section 201(h)(1) instead of section 201(h) for device definition?
Use 201(h)(1) when quoting the device definition, referring to specific subparagraphs (A)-(C), or maintaining consistency with other definitions in the same document that use specific paragraph references.
How should industry align their submissions with FDA’s referencing conventions?
Industry should follow the same conventions described in the guidance when submitting premarket applications, reports, and communications, using section 201(h) for general device references and 201(h)(1) for precise citations.
What You Need to Do 👇
Recommended Actions
- Review existing documentation to understand that references to section 201(h) refer to the device definition now in section 201(h)(1)
- Update future documentation to:
- Use section 201(h) or 201(h)(1) when referring to devices
- Use specific reference to section 201(h)(2) when referring to counterfeit devices
- Maintain consistency in referencing within the same document
- Ensure that any enforcement discretion policies are not applied to counterfeit devices
- Align submissions and communications to FDA with these referencing conventions when practicable
- Be aware that counterfeit devices are subject to refusal of admission into the United States and may be destroyed by FDA
Key Considerations
Software
- Software functions excluded pursuant to section 520(o) are not considered devices
- Existing enforcement policies for device software functions do not apply to counterfeit devices
Other considerations
- References to section 201(h) in existing documents should be understood to refer to the device definition now in section 201(h)(1)
- Future references can use either section 201(h) or 201(h)(1) when referring to devices
- Specific reference to section 201(h)(2) should be used when referring to counterfeit devices
- Enforcement policies that describe FDA’s intent not to enforce certain requirements do not apply to counterfeit devices
Relevant Guidances 🔗
Related references and norms 📂
- No specific norms or ISO standards are referenced in this guidance