fda-device · Food and Drug Administration · Rule · Published 1997-01-21 · Effective 1997-01-21 · 62 FR 2900
Document
Document number
97-1336
Federal Register citation
62 FR 2900
CFR reference
21 CFR 872
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1997-01-21
Effective date
1997-01-21
HHS docket
Docket No. 95N-0033
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 the endodontic dry heat sterilizer, a medical device. Commercial distribution of this device must cease, unless a manufacturer or importer has filed with FDA a PMA or a notice of completion of a PDP for its version of the endodontic dry heat sterilizer within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require a PMA or notice of completion of a PDP for the preamendments device.