Description
This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S. Food and Drug Administration (FDA or Agency) through the Pre-Request for Designation (Pre-RFD) process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP) and helps a sponsor understand the type of information to provide in a Pre-RFD.
Scope & Applicability
Product Classes
4Products 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
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2The legal status of Pre-RFD feedback
How the product achieves its intended purpose.
Related CFR Sections (5)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
- 21CFR3.7§ 3.7 Request for designation.
(a) Who should file: the sponsor of:Read full regulation →
- 21CFR201.128§ 201.128 Meaning of “intended uses”.
The words intended uses or words of similar import in §§ 201.5 , 201.115 , 201.117 , 201.119 , 201.120 , 201.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such peRead full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →
Related Warning Letters (10)
- 2025-12-23
Unapproved New Drugs
TITAN SARMS LLC
- 2025-12-23
Unapproved New Drugs
Pinnacle Professional Research dba Pinnacle Peptides
- 2025-12-23
Unapproved New Drugs
Prime Sports Nutrition
- 2025-12-23
Unapproved New Drugs
Atomix LLC
- 2025-12-23
Unapproved New Drugs
Dynamic Health Group dba SARMS AMERICA
- 2025-12-16
Unapproved New Drugs/Misbranded
Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS
- 2025-11-25
Unapproved New Drugs/Adulterated/Misbranded
Handelnine Global, LLC dba Navafresh
- 2025-11-25
Unapproved New Drugs
Swift Digital Group LLC dba Swadesii
- 2025-11-25
Unapproved New Drugs
VarunKart Group LLC dba Organic Wellnesses
- 2025-11-25
Unapproved New Drugs
Distacart Inc.
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)