Biomedical Engineering Reference
In-Depth Information
17
Food and Drug Administration Safe Medical Device Act, 1991.
18
Food and Drug Administration Modernization Act, 1997.
19
Food and Drug Administration Medical Device User Fee and Modernization Act, 2002.
20 Food and Drug Administration Premarket Approval Application;
United States Govern-
ment Code of Federal Regulations, Title 21, Part 800-1299; Food and Drugs
; Office of
the Federal Register National Archives and Records Administration, US Government
Printing Office, Washington DC, April 2007.
21 O'Grady J and Bordon D. 'Global Regulatory Registration Requirements for Collagen-
based Combination Products: Points to Consider',
Advanced Drug Delivery Reviews SS
2003, 1699-1721.
22 ISO 10993,
Biological Evaluation of Medical Devices
, International Standards Organi-
zation, 1994.
23 Council Directive 93/42/EEC of June 14, 1993,
Medical Device Directive, 1993
.
24 Council Directive 65/65 EEC of 26 January 1965 on the approximation of provisions laid
down by Law Regulation or Administration Action relating to proprietary medicinal
products, 1965.
25 European Commission, MEDDEV 2.1/3, March 1998
Guidelines relating to the demar-
cation between Active Implantable Medical Devices (AIMD), Medical Device Directive
(MDD) and Medicinal Product Directive (MPD) and related devices, 1998
.
26 Global Harmonization Task Force (GHTF); www.ghtf.org
27
Summary Technical Documentation for Demonstrating Conformity to the Essential
Principles of Safety and Performance of Medical Devices (STED)
, Global Harmoniza-
tion Task Force, 2002.
28 Food and Drug Administration,
A Pilot Program to Evaluate a Proposed Globally
Harmonized Alternative for Premarket Procedures; Guidance for Industry and Staff
,
November 10, 2005.
29
United States Government Code of Federal Regulations, Title 21, Part 820
:
Quality
System Regulation
, US Government Printing Office; April 2007.
30 European Commission, MEDDEV 2.1/1,
Guidelines Relating to the Application of 90/
385/EEC and 93/42/EEC, 1994
.
31
United States Government Code of Federal Regulations; Title 21, Part 812, Good
Clinical Practice.
32
ICH Guidance E6: Good Clinical Practice: Consolidated Guidelines
, 10 June 1996.
33 Declaration of Helsinki 1964,
Ethical Principles for Medical Research Involving Human
Subjects
, 1964.
34 Food and Drug Administration Guidance for Industry;
Chronic Cutaneous Ulcer and
Burn Wounds - Developing Products for Treatment
, June 2006.
35 Boyd CR, Tolson MA and Copes WS, 'Evaluating trauma care: the TRISS method',
J
Trauma
, 1987,
27
, 370-8.
36 Knaus WA, Zimmerman JE,
et al
. 'APACHE - acute physiology and chronic health
evaluation: a physical based classification system',
Crit Care Med
, 1981,
9
, 591-7.
37 Food and Drug Administration Guidance for Industry,
Chronic Cutaneous Ulcer and
Burn Wounds - Developing Products for Treatment
, June 2006.
38
United States Government Code of Federal Regulations, Title 21, Part 814
,
Humanitar-
ian Device Exemption
, Federal Food, Drug and Cosmetic Act, April 2007.
39
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P), United States
Government Code of Federal Regulations, Title 21, Part 1271
, United States Food and
Drug Administration, April 2007.
40 Commission Directive 2004/23/EC/EC of March 2004 on setting standards of quality
