Description
This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies.
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.
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
Example of a potential platform technology
A type of ATMP involving recombinant nucleic acids or viral vectors.
Anti-TNF-alpha drug substance and drug product
Stakeholders
2Entity responsible for submitting applications under section 524B
Entity expected to have control over manufacturing for biological products
Regulatory Context
Attributes
3Eligibility factor for platform technology designation
Status granted to technologies meeting eligibility factors
Information from completed tests or studies to support designation
Identified Hazards
Hazards
1Risk to be evaluated when adapting platform technology
Related CFR Sections (4)
- 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 →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR3.7§ 3.7 Request for designation.
(a) Who should file: the sponsor of:Read full regulation →
See Also (8)
- Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry (Status: Final)
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)
- Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff (Status: Final)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products (Status: Draft)
- Application User Fees for Combination Products: Guidance for Industry and FDA 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)
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)