References

Glossary key term references are listed below.

Key Term References

All | C E F I O U
There are currently 31 references in this directory beginning with the letter F.
FDA 21CFR1
FDA 21CFR3
FDA 21CFR4
FDA 21CFR50
FDA 21CFR56
FDA 21CFR600
FDA 21CFR7
FDA 21CFR801
FDA 21CFR803
FDA 21CFR806
FDA 21CFR807
FDA 21CFR809
FDA 21CFR810
FDA 21CFR812
FDA 21CFR814
FDA 21CFR820
FDA 21CFR821
FDA 21CFR822
FDA 21CFR830
FDA 21CFR860
FDA 21CFR99
FDA guidance: Custom Device Exemption (2014)
FDA guidance: Deciding When to Submit...(2014)
FDA guidance: Design Control Guidance...(1997)
FDA guidance: Medical Device Accessories...(2017)
FDA guidance: Reprocessing Medical Devices...(2017)
FDA guidance: The 510(k) Program...(2014)
FDA website: Guide to Inspections of Quality Systems
FDA website: Medical Device Reporting (MDR)...
FDA website: Premarket Notification 510(k)
FDA website: Who Must Register...
  • US (FDA and OLRC) regulations, US FDA guidance documents, European (EU) regulations, and IMDRF documents are available online for free.
  • International (ISO and IEC) standards are available for purchase from ISO or IEC, and in some cases, a preview or read-only version may be available online for free.
    • American (US) versions of international medical device standards are available for purchase from AAMI which offers significant discounts for AAMI members.
    • Other national versions of international standards are available for purchase from national standards bodies.

For an introduction to medical device standards and regulations, view online video Course 250 – Regulatory Compliance.