Description
Additional copies are available from:Office of Combination ProductsFood and Drug AdministrationWO32, Hub/Mail Room #512910903 New Hampshire AvenueSilver Spring, MD 20993(Tel) 301-796-8930(Fax) 301-847-8619Combination Products.
Scope & Applicability
Product Classes
5Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
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
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
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
Products 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.
Regulatory Context
Attributes
4Criterion used to distinguish between drug and device classification
Determining factor for product classification
Spatial requirement for the chemical action exclusion in device definition
Determines the classification of a product
Related CFR Sections (1)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (10)
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-16
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Green Valley Fertility Partners
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
BioXtek LLC
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Lux Therapeutics LLC dba Ponya Therapeutics LLC
- 2025-10-07
CGMP/Deviations/Biologics License Application (BLA)
New Life Medical Services, LLC
- 2025-09-16
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
NuVida Medical LLC
- 2025-08-26
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Platinum Biologics LLC
- 2025-08-26
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Innate Healthcare Institute
- 2025-07-01
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
InVia Fertility Specialists, PLLC
See Also (8)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry (Status: Final)
- Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry (Status: Final)
- Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry (Status: Final)
- Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry (Status: Final)
- Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry (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)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry (Status: Final)