Medical Devices; Effective Date of Requirement for Premarket Approval for Class III Preamendments Devices
fda-device · Food and Drug Administration · Rule · Published 1996-09-27 · Effective 1996-09-27 · 61 FR 50704
Document
Document number
96-24753
Federal Register citation
61 FR 50704
CFR reference
21 CFR 868
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1996-09-27
Effective date
1996-09-27
HHS docket
Docket No. 95N-0084
Abstract
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for 41 class III medical devices. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices.