Description
This document provides guidance to industry and FDA staff on application user fees for combination products as defined under 21 CFR 3.2(e). Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts. If the applicant chooses to submit two applications for a cross-labeled combination product, each would be assessed the applicable user fee for each application. In the infrequent situation when FDA determines that a single application is not appropriate and separate applications are warranted, the guidance describes how the total application fee amount might be reduced when the applicant qualifies for certain waiver provisions under the Prescription Drug User Fee Act (PDUFA) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Scope & Applicability
Product Classes
3Products 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.
Drug for a rare disease or condition
Device for rare diseases or conditions
Stakeholders
3Target audience for the compliance guide
Resource for applicants regarding combination products
Entity exempt from certain application fees
Regulatory Context
Attributes
1Statutory deadline for submitting a refund request
Related CFR Sections (2)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR4.2§ 4.2 How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for purposes of this subpart:Read full regulation →
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)
- How to Write a Request for Designation (RFD): Guidance for Industry (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)