Skip to main content

Currently Skimming:

Appendix G Glossary and Acronyms
Pages 422-432

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 422...
... . Class I medical devices.
From page 423...
... ) Class II medical devices.
From page 424...
... Requirements (e.g., registering all manufacturing loca tions, following quality system regulations) that all classes of medical devices must meet to be lawfully marketed.
From page 425...
... Humanitarian Use Device. A device that is intended to benefit patients suffering from a disease or condition that affects fewer than 4,000 individuals in the United States per year.
From page 426...
... A medical device available to consumers after the enactment of the Medical Device Amendments of 1976. Postmarket.
From page 427...
... A condition that affects or is manifested in (causes symp toms in) fewer than 4,000 individuals in the United States per year.
From page 428...
... Requirements for Class II medical devices that are in tended to ensure safety and effectiveness. Unlike general controls, spe cial controls may vary for different types of devices.
From page 429...
... Unlabeled use. Use of a drug or medical device for a purpose, patient group, or other use that is not specifically approved by the FDA for use as indicated on the product's label.
From page 430...
... Food and Drug Administration GAO Government Accountability Office (formerly General Accounting Office) GHTF Global Harmonization Task Force GMDN Global Medical Device Nomenclature GMP Good Manufacturing Practices HDE Humanitarian Device Exemption HIPAA Health Insurance Portability and Accountability Act of 1996 HUD Humanitarian Use Device ICD International Classification of Diseases ICH International Conference on Harmonisation IDE Investigational Device Exemption IOM Institute of Medicine IRB Institutional Review Board ISO International Organization for Standardization ISPE International Society for Pharmacoepidemiology JCAHO Joint Commission on the Accreditation of Healthcare Organizations LVAD left ventricular assist device
From page 431...
... 101­629 Safe Medical Devices Act of 1990
From page 432...
... 108­155 Pediatric Research Equity Act of 2003 P.L. 108­214 Medical Devices Technical Corrections Act of 2004


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.