Description
For questions regarding this document, contact:Address UpdatePatricia Y. Love, MD, Office of Combination Products, at 301-427-1934.
Scope & Applicability
Product Classes
1Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
The entity responsible for responding to SLC notifications and orders.; Entity responsible for submitting labeling supplements or rebuttals; Entity responsible for submitting labeling supplements and appeals
Regulatory Context
Attributes
4Assignment of a lead Agency center for the review and regulation of a combination product.
A functional role of sodium in food
Chemicals that migrate from the container closure system into the formulation
Potential for device materials to release extractables into the product.
Related CFR Sections (2)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
See Also (8)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)
- Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff (Status: Final)
- Cellular Therapy for Cardiac Disease: Guidance for Industry (Status: Final)
- How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
- User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Status: Final)
- Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry (Status: Final)
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff (Status: Draft)