Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
fda-device · Food and Drug Administration · Rule · Published 2016-01-05 · Effective 2016-01-05 · 81 FR 364
Document
Document number
2015-33163
Federal Register citation
81 FR 364
CFR reference
21 CFR 884
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-01-05
Effective date
2016-01-05
HHS docket
Docket No. FDA-2014-N-0298
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.