Description
For questions regarding this document, contact:Office of Combination Products (OCP) at 301-796-8930 orcombination@fda.gov
Scope & Applicability
Product Classes
5Products 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.
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Defined in section 201(h) of the FD&C Act; Instrument or apparatus which does not achieve primary purpose through chemical action; Product classification based on primary intended purpose and chemical action
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
A product that is only either a drug, a device, or a biological product.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
4FDA's decision on which center will regulate a product
assignment of other combination products presenting similar safety and effectiveness questions
Single mode of action expected to make the greatest contribution to therapeutic effects
Required information for related products in an RFD.
Related CFR Sections (6)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR3.7§ 3.7 Request for designation.
(a) Who should file: the sponsor of:Read full regulation →
- 21CFR3.8§ 3.8 Letter of designation.
(a) Each request for designation will be reviewed for completeness within 5 working days of receipt. Any request for designation determined to be incomplete will be returned to the applicant with a request for the missing information. The sponsor of an accepted request for designation will be notifiRead full regulation →
- 21CFR3.9§ 3.9 Effect of letter of designation.
(a) The letter of designation constitutes an agency determination that is subject to change only as provided in paragraph (b) of this section.Read full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
- 21CFR3.4§ 3.4 Designated agency component.
(a) To designate the agency component with primary jurisdiction for the premarket review and regulation of a combination product, the agency shall determine the primary mode of action of the product. Where the primary mode of action is that of:Read full regulation →
Related Warning Letters (1)
- 2020-08-19
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
Predictive Biotech
See Also (8)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA Staff (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)
- New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry (Status: Final)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for Industry (Status: Final)
- Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff (Status: Draft)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (Status: Final)