Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
fda-device · Food and Drug Administration · Rule · Published 2012-06-22 · Effective 2012-09-20 · 77 FR 37573
Document
Document number
2012-15244
Federal Register citation
77 FR 37573
CFR reference
21 CFR 870
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2012-06-22
Effective date
2012-09-20
HHS docket
Docket No. FDA-2011-N-0522
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 a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.