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Biomedical Engineering: Biomedical Standards (Devices)

Biomedical Standards (Devices)

What are biomedical 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.

Standards and regulations exist for biomedical devices, biotechnology as well as biosafety.  Biological safety or biosafety is the application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards. Agencies primarily responsible for regulating biomedical stanards 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.

Where to start: 

Federal Agencies: 

Environmental Protection Agency (EPA)

EPA develops and enforces regulations that span many environmental categories, including toxicology and chemical reporting. 


Food and Drug Administration (FDA)

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.


Nationa Institute of Health (NIH)

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.


US Department of Agriculture (USDA)

Includes guidance for animal testing, biotechnology, wildlife and plant protection. 

 

Device Regulation

 

For the latest information visit: 

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. 

 

There are two methods to determine which class your device may fall under:

  1.  go directly to the classification database and search for a part of the device name
  2.  browse the device panel (medical specialty) to which your device belongs

 


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.