Description
This guidance provides to you, medical device manufacturers of communicable disease tests, information about performing studies to support modifying the indication for use to include testing of cadaveric blood pecimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). This guidance makes recommendations about:
Scope & Applicability
Product Classes
2Medical device manufacturers of communicable disease tests.
Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
Stakeholders
1Tool developer offers its MDDT to medical device manufacturers.
Regulatory Context
Attributes
3cutoff was chosen to optimize clinical specificity
The LoD provides a measure of the analytical sensitivity
Issues recommended for consideration in studies.
Identified Hazards
Hazards
2biological process occurring post-mortem that should be quantified in specimens
due to transfusion or infusion of fluids resulting in false negative test results
Related CFR Sections (1)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.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)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff (Status: Final)
- Validation of Procedures for Processing of Human Tissues Intended for Transplantation: 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)