Biomedical Engineering: Compliance in Biomedical Engineering

• FDA - Center for Devices & Rediological Health

  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

• Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

  FDA: U.S. Food & Drug Administration

• 21 CFR Part 820 - QUALITY SYSTEM REGULATION

• FDA Quality and Compliance (Medical Devices)

• ISO 13485 Medical Devices
• ISO 13485:2016
• ISO 13485 & MDR Blog
• ISO 14971 Risk Management for Medical Devices: the definitive guide

Consult your instructor about access to the full-text of these ISO standards

• CDRH Learn

  FDA's Center for Devices and Radiological Health web page for industry education.

• Device Design

  Comprehensive Regulatory Assistance

• FDA Medical Devices Databases

  Presents a table of FDA databases related to medical devices. There are many hyperlinks among the databases.

• FDA Recognized Consensus Standards Database

  Created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards.

• Product Classification for Medical Devices

  Helps users identify devices and their product codes that are used in many FDA databases. This database also lists Recognized Consensus Standards and links to the Code of Federal Regulations and the Total Product Life Cycle report which lists problems.

• AccessGUDID - Global Unique Device Identification Database

  The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).