Description
Additional copies are available from:Office of Combination ProductsFood and Drug AdministrationWO32, Hub/Mail Room #5129,10903 New Hampshire Avenue,Silver Spring, MD 20993301-796-8930(Fax) 301-847-8619http://www.fda.gov/CombinationProducts/default.htmcombination@fda.gov
Scope & Applicability
Product Classes
1Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
The guidance provides recommendations to reduce the risk of transmission of disease agents associated with sepsis by HCT/Ps.
Stakeholders
1Sponsor
Entity responsible for submitting applications under section 524B
See Also (8)
- Classification of Products as Drugs and Devices and Additional Product Classification Issues: 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Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff (Status: Draft)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (Status: Final)