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Electronic Code of Federal Regulations (e-CFR)
Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H—MEDICAL DEVICES
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart D—De Novo Classification
21 CFR Subpart D - Subpart D—De Novo Classification
CFR
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§ 860.200 Purpose and applicability.
§ 860.210 De Novo request format.
§ 860.220 De Novo request content.
§ 860.230 Accepting a De Novo request.
§ 860.240 Procedures for review of a De Novo request.
§ 860.250 Withdrawal of a De Novo request.
§ 860.260 Granting or declining a De Novo request.
Source:
86 FR 54847
, Oct. 5, 2021, unless otherwise noted.