Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
fda-device · Food and Drug Administration · Rule · Published 2021-12-29 · Effective 2021-12-29 · 86 FR 73971
Document
Document number
2021-28160
Federal Register citation
86 FR 73971
CFR reference
21 CFR 882
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-12-29
Effective date
2021-12-29
HHS docket
Docket No. FDA-2021-N-0573
Abstract
The Food and Drug Administration (FDA or we) is classifying the diagnostic neurosurgical microscope filter into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the diagnostic neurosurgical microscope filter's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.