Regulatory concerns in the development of biologic-biomaterial combinations

Journal of Biomedical Materials Research

Volumn 33, Issue 3, 1996, Pages 199-203

  Chapekar, Mrunal S ^a,b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Center for Biologics Evaluation/Res   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MATERIALS; DRUG PRODUCTS; HEALTH RISKS; LAWS AND LEGISLATION;

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER); CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH); CENTER FOR DRUGS EVALUATION AND RESEARCH (CDER); FOOD AND DRUG ADMINISTRATION (FDA);

BIOMATERIALS;

BIOMATERIAL;

ARTICLE; BIOENGINEERING; BIOPROSTHESIS; FOOD AND DRUG ADMINISTRATION; LAW;

BIOCOMPATIBLE MATERIALS; BIOTECHNOLOGY; HYBRID CELLS; LEGISLATION, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030249781     PISSN: 00219304     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-4636(199623)33:3<199::AID-JBM10>3.0.CO;2-C     Document Type: Article

References (15)

1. 3 ProGluGly-elements. J. Am. Chem. Soc. 114: 727-733; 1992.
2. Moore, J. C.; Matukas, V. J.; Deatherage, J. R.; Miller, E. J. Craniofacial osseous restoration with osteoinductive proteins in a collagenous delivery system. Int. J. Oral Maxillofac. Surg. 19:172-176; 1990.
3. Toriumi, A. M.; Kotler, H. S.; Luxenberg, D. P.; Holtrop, M. E.: Wang, E. A. Mandibular reconstruction with a recombinant bone-inducing factor. Arch. Otolaryngol. Head Neck Surg. 117:1101-1112; 1991.
4. Arnaud, E.; Morieux, C.; Wybier, M.; de Vernejoul, M. C. Potentiation of transforming growth factor (TGF-β1) by natural coral and fibrin in a rabbit cranioplasty model. Calcif. Tissue Int. 54:493-498; 1994.
5. Sullivan, S. J.; Maki, T.; Borland, K. M.; et al. Biohybrid artificial pancreas: long term implantation studies in diabetic pancreatectomized dogs. Science 252:718-721; 1991.
6. Aebischer, P.; Tresco, P. A.; Winn, S. R.; Greene, L. A.; Jaeger, C. B. Long-term cross-species brain transplantation of a polymer-encapsulated dopamine-secreting cell line. Exp. Neurol. 111:269-275; 1991.
7. Assignment of Agency Component for Review of Premarket Applications. Fed. Register 56(225):58754-58759; 1991.
8. Safe Medical Devices Act of 1990 (SMDA). Public Law 101-629, enacted November 28, 1990.
9. Fed. Register 58(197):53248-53251; 1993.
10. Food and Drug Administration, Department of Health and Human Services. Code of Federal Regulation, Title 21, Chap. 1. Washington, DC: Office of the Federal Register National Archives and Records Administration; 1995.
11. Federal Food, Drug, and Cosmetic Act, as Amended and related laws, Public Health Service Act: Biological products. Section 262 and 263. Washington DC: US Government Printing Office; HHS Publication (FDA) 172-175; 1989.
12. Federal Food, Drug, and Cosmetic Act, as Amended and related laws, Chap. V. Washington, DC: US Government Printing Office, HHS Publication (FDA) 43-137; 1989.
13. Kossovsky, N.; Millett, D.; Juma, S.; et al. In vivo characterization of the inflammatory properties of poly(tetrafluoroethylene) particulate. Biomed. Mater. Res. 25:1287-1301; 1991.
14. Akagawa, Y.; Hashimoto, M.; Knodo, N.; Yamasaki, A.; Tsuru, H. Tissue reaction to implanted biomaterials. J. Prosthet. Dent. 53(5):681-686; 1985.
15. FDA modified matrix of ISO-10993-1. Biological evaluation of medical devices part 1: evaluation and testing. CDRH Blue Book Memorandum (G95-1), May 1, 1995.