Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I
fda-device · Food and Drug Administration · Rule · Published 2019-04-12 · Effective 2019-05-13 · 84 FR 14865
Document
Document number
2019-07290
Federal Register citation
84 FR 14865
CFR reference
21 CFR 876
Type
Rule
Action
Final classification action.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2019-04-12
Effective date
2019-05-13
HHS docket
Docket No. FDA-2018-N-3066
Abstract
The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.