Biomedical Engineering Reference
In-Depth Information
submission, review and approval by one competent authority, such as the FDA,
could be accepted by competent authorities in other countries.
Postmarket surveillance and risk management data will become more critical in
monitoring the continued safe use of these advanced biomaterials for skin loss and
document long term safety and effectiveness profiles. Providing a framework for
approval globally of these products will facilitate the availability of these advanced
biomaterials for skin loss to improve the quality of life for these patient populations.
7.12
References
1 Council Directive 93/42 EEC Medical Device Directive (MDD),
Official Journal of the
European Communities
, June 14, 1993.
2
United States Government Code of Federal Regulations, Title 21, Part 814; Food and
Drugs
, Office of the Federal Register National Archives and Records Administration,
US Government Printing Office, Washington DC, April 2007.
3
United States Government Code of Federal Regulations Title 21, Part 814. Premarket
Approval of Medical Devices
, US Government Printing Office, Washington DC, April
2007.
4
United States Government Code of Federal Regulations
, Office of the Federal Register,
April 2007, US Government Printing Office, Washington, DC, April 2007.
5 US Food and Drug Administration Center for Devices and Radiological Health Product
Code Database (http://www.fda.gov/cdrh/productcode.html), 2007.
6 United States Food and Drug Administration Website www.fda.gov, 2007.
7
Federal Food, Drug and Cosmetic Act, as amended, and Related Laws (513 (I) (1) (A)
g)
, US Department of Health and Human Services, Public Health Service, Food and Drug
Administration, US Government Printing Office, Washington, DC, 1986.
8 Food and Drug Administration,
Format for Traditional and Abbreviated 510(k)s:
Guidance for Industry and Staff
, 2005.
9
United States Government Code of Federal Regulations, Title 21, Parts 800-1299, Food
and Drugs
, Office of the Federal Register National Archives and Records Administra-
tion, US Government Printing Office, Washington DC, April 2007.
10 Council Directive 93/42 EEC Medical Device Directive (MDD),
Official Journal of the
European Communities
, June 14, 1993.
11 Council Directive 93/42 EEC Medical Device Directive (MDD),
Official Journal of the
European Communities
, June 14, 1993.
12 ISO 13485:2003
Medical Device - Quality Management Systems - Requirements for
Regulatory Purposes
, International Standards Organization, 2003.
13 Council Regulation EEC 2309/93 of July 1993 laying down authorization and supervi-
sion of medicinal products for human and veterinary use and establishing a European
agency for the evaluation of medicinal products, 1993.
14 Annex to Council Regulation EEC 2309/93 of July 1993 laying down authorization and
supervision of medicinal products for human and veterinary use and establishing a
European agency for the evaluation of medicinal products, 1993.
15 Council Regulation EEC 2309/93 Part B of July 1993 laying down authorization and
supervision of medicinal products for human and veterinary use and establishing a
European agency for the evaluation of medicinal products, 1993.
16 European Agency of the Evaluation of Medicinal Products (EMEA) website
www.emea.eu.int, 2007.
