The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.
The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.
The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.
The following documents relating to the production, regulation and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:
| FDA CFR: | |
| 21 CFR 3: Product Jurisdiction: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=3 | |
| 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=58 | |
| FDA/CDRH CFR and Guidances: | |
| 21 CFR Part 803: Medical Device Reporting: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=803 | |
| 21 CFR 812: Investigational Device Exemptions: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=812 | |
| 21 CFR 814: Premarket Approval of Medical Devices : | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=814 | |
| 21 CFR 820: Quality System Regulation: | |
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=820 | |
| Design Control Guidance for Medical Device Manufacturers: | |
| http://www.fda.gov/cdrh/comp/designgd.pdf | |
| Preproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers (FDA 90-4236): | |
| http://www.fda.gov/cdrh/manual/appende.html | |
| The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program—Draft Guidance for Industry and FDA Staff: ASTM F2212-08 history
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