fda-device · Food and Drug Administration · Rule · Published 2020-04-02 · Effective 2020-04-01 · 85 FR 18444
Document
Document number
2020-06278
Federal Register citation
85 FR 18444
CFR reference
21 CFR 862
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2020-04-02
Effective date
2020-04-01
HHS docket
Docket No. FDA-2020-N-0011
Abstract
The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017. FDA published a final amendment, final order in the Federal Register of December 30, 2019 ("Final Order") codifying the two Federal Register notices. The present revisions are necessary to correct editorial errors to ensure that the codified is consistent with the exemptions in the Federal Register notices. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.