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Biomedical Engineering: 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:
- TechStreet This link opens in a new windowTechstreet offers simultaneous access to a custom set of standards in electronic format. Includes automatic updates. Includes ISO standards related to medical devices and health services.
- ASTM Compass (formerly Standards and Engineering Digital Library (SEDL)) This link opens in a new windowASTM includes testing, materials, processing of medical devices as well as many other areas.
- IEEE Xplore This link opens in a new windowIEEE Standards related to biotechnology include electronics and health informatics.
- Materials for Medical Devices This link opens in a new windowA comprehensive set of mechanical, physical, biological response, and drug compatibility properties for the materials and coatings used in cardiovascular and orthopaedic medical devices.
- FDA - Medical Devices Standards DatabaseRecognized Consensus Standards for medical devices by FDA. The standards have been developed by the Center of Devices and Radiological Health (CDRH).
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.
National Institute of Health (NIH)
Its operating divisions include:
- Clinical and Healthcare
- Scientific Data Sharing
- Biosafety, Biosecurity, and Emerging Biotechnologies
- Technology Transfer and Innovation
- Science Policy Coordination, Collaboration & Reporting
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.
- Most Class I devices are exempt from Premarket Notification 510(k)(with the exception of Reserved Devices)
- All Class II: Premarket Notification 510(k) requires demonstration of Substantial Equivalence (SE) to legally marketed device in U.S. SE means “Substantial Equivalence” or “Just as Safe and Just as Effective”.
- Most Class III: Premarket Approval (PMA) requires proof of reasonable assurance of safety and effectiveness.
- An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application.
There are two methods to determine which class your device may fall under:
- go directly to the classification database and search for a part of the device name
- 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.
- Product Classification Database
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
Please note: The Medical Device Amendments of May 28, 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices. -
Food and Drug Administration Safety and Innovation Act (FDASIA)The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health by: 1) Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; 2) Promoting innovation to speed patient access to safe and effective products; 3) Increasing stakeholder involvement in FDA processes; and 4) Enhancing the safety of the drug supply chain.
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MAUDE - Manufacturer and User Facility Device ExperienceMAUDE data represents voluntary reports of adverse events involving medical devices.