Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip
fda-device · Food and Drug Administration · Rule · Published 2022-02-14 · Effective 2022-02-14 · 87 FR 8192
Document
Document number
2022-03104
Federal Register citation
87 FR 8192
CFR reference
21 CFR 880
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-02-14
Effective date
2022-02-14
HHS docket
Docket No. FDA-2021-N-0994
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the spore test strip 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 spore test strip'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.