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发帖数: 25265 | 1 Premarket approvalFrom Wikipedia, the free encyclopediaJump to: navigation,
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Premarket approval (PMA) is the U.S. Food and Drug Administration (FDA)
process of scientific and regulatory review to evaluate the safety and
effectiveness of Class III medical devices and is significantly different
from the Premarket Notification process known as 510(k). Class III devices
are those that support or sustain human life, are of substantial importance
in preventing impairment of human health, or which present a potential,
unreasonable risk of illness or injury. Due to the level of risk associated
with Class III devices, FDA has determined that general and special controls
alone are insufficient to assure the safety and effectiveness of class III
devices. Therefore, these devices require a PMA) application under section
515 of the FD&C Act in order to obtain marketing clearance. Note that some
Class III preamendment devices may require a Class III 510(k). [1]
Contents [hide]
1 Device classes
2 See also
3 References
4 Notes
[edit] Device classesClass I: Must only follow FDA general controls, no 510(
k) or PMA needed.[2]
Class II: Use the 510(k) process which uses a pre-existing similar device in
the market called a "predicate device" for comparison.
Class III: Use the PMA process whereby no "predicate device" exist, such as
in a New Drug Application.
[edit] See alsoFederal Food, Drug, and Cosmetic Act
[edit] ReferencesSEC. 515. 21 USC §360e Premarket Approval; General
Requirement
PREMARKET APPROVAL OF MEDICAL DEVICES
PMA Guidance Documents
[edit] Notes1.^ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm
2.^ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
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