Guidance and Standards

In addition to regulation and statutes, FDA CDRH also utilizes standards and guidance to control the development of medical devices. Some of setting organizations that CDRH relies on include American National Standards Institute (ANSI), Institute of Electrical and Electronic Engineers (IEEE) and Underwriters Laboratories. A listing of standards utilized by CDRH can be found at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Good Guidance Practice (GGP) documents are documents prepared for CDRH staff, regulated industry and the public that relate to:

• the processing, content, and evaluation of regulatory submissions
• the design, production, manufacturing, and testing of regulated products
• the inspection and enforcement procedures

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both. Guidance relevant to medical devices can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

Research by Eliza Brannigan & Kristin Stiner