Description
The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.
Key Topics
Terms and concepts identified from this document
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.
Products granted RMAT designation status.
Devices providing for more effective treatment or diagnosis of life-threatening diseases
Stakeholders
5Entity responsible for submitting applications under section 524B
FDA official consulted for device definition or center assignment issues.; Official consulted for jurisdictional determinations.; Official determining center assignment
Single individual designated to represent the OTC IWG in communications with FDA.
FDA Point of Contact for meeting coordination.
Office of Combination Products, assists in resolving regulatory issues.
Regulatory Context
Regulatory Activities
10Combination Product Agreement Meetings established by the Cures Act; Combination Product Agreement Management
Mechanism to request FDA feedback on planned modeling activities.
repeat-dose toxicity studies that support a carcinogenicity Special Protocol Assessment (SPA)
ANDA submission containing a waiver request
BLA under section 351(a) or 351(k)
Rule does not apply to products marketed under an NDA
IND for treatment use; Regulatory submission required for clinical trials and expanded access.
A medical device submission type (510(k)).
Marketing submission type requiring QMS information; Type of marketing submission requiring QMS information
Investigational New Drug submissions
Document Types
3Documentation artifact related to NDI notifications
Electronic Common Technical Document format for submissions.
The required electronic format for submissions to the FDA.
Attributes
1Single mode of action expected to make the greatest contribution to therapeutic effects
Technical Details
Testing Methods
1scientific issues appropriate for application-based mechanisms
Processes
1chemistry, manufacturing, and controls
Standards & References
External Standards
2Public Health Service Act, specifically section 402(j)(1)(A)(ii) regarding clinical trials.
Licensing of biological products
Related CFR Sections (1)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications (Status: Draft)
- Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry (Status: Final)
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry (Status: Final)
- Competitive Generic Therapies (Status: Final)
- Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties (Status: Draft)
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry (Status: Final)