Delegations of Authority and Organization; Center for Devices and Radiological Health
fda-device · Food and Drug Administration · Rule · Published 1998-05-18 · 63 FR 27207
Document
Document number
98-13046
Federal Register citation
63 FR 27207
CFR reference
21 CFR 5
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-05-18
Abstract
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect a new delegation that authorizes the Division Directors, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) to approve, disapprove, or withdraw approval of product development protocols and applications for premarket approval for medical devices.