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Lichtenberger Engineering Library

Biomedical Engineering

Standards

In the United States, responsibility for setting product and process standards rests almost exclusively with the private sector. Government agencies rely heavily on voluntary standards, which they often incorporate into regulatory and procurement requirements. The International Organization for Standardization (ISO) Guide 2: 2004 defines a standard as a "document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities of their results, aimed at the achievement of the optimum degree of order in a given context."  Standards can serve many purposes, including: fitness for purpose, compatibility, interchangeability, variety control, safety, protection of the environment, and product protection against climatic or other adverse conditions.

Regulations

Biotechnology is a powerful new technology that poses substantial and often unique threats to biological diversity--as much as to human health, communities and economies. Biological safety or biosafety is the application of knowledge, techniques and equipment to preventpersonal, laboratory and environmental exposure to potentially infectious agents or biohazards.Agencies primarily responsible for regulating biotechnology in the United States are: US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and Food and Drug Administration (FDA). Products are regulated according to their intended use, with some products being regulated under more than one agency.

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products.

CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions

Many of the regulations enforced by FDA with regard to medical devices can be found in Title 21 Code of Federal Regulations (CFR) Part 800 to Part 1299. This reference is abbreviated to 21 CFR 800 to 1299.

Includes guidance for Allergenics, Blood, Cellular & Gene Therapy, Tissue Guidances, Vaccines, Xenotransplantation, Clinical Trials, Combination Products, Drugs, and Import and Export.

Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations.

Monitors scientific progress in human genetics research involving Recombinant DNA, Genetic Technologies, Human Gene Transfer, dual use research. Involved in the optimization of the policies and requirements concerning the conduct and oversight of clinical research.

 

Device Regulations

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299


Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. 


Device manufacturers and importers of all devices:class III devices, and those class II devices that are permanently implantable, life supporting, or life sustaining; and class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation.