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D.C. Mun. Regs. tit. 22-B, ch. 105 – Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices | Midpage
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District of Columbia Municipal Regulations
Title 22
22-B
Chapter 22-B105
D.C. Mun. Regs. tit. 22-B, ch. 105
Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices
District of Columbia, Office of the Secretary
22-B10500
Who Must Register and Submit a Device List
22-B10501
Time for Establishment Registration and Device Listing
22-B10502
How and Where to Register Establishments and List Devices
22-B10503
Information Required or Requested for Establishment Registration and Device Listing
22-B10504
Amendments to Establishment Registration
22-B10505
Updating Device Listing Information
22-B10506
Additional Listing Information
22-B10507
Notification of Registrant
22-B10508
Inspection of Establishment Registration and Device Listing
22-B10509
Misbranding by Reference to Establishment Registration or to Registration Number
22-B10510
Establishment Registration and Device Listing for U.S. Agents of Foreign Manufacturers of Devices
22-B10511
Exemptions for Device Establishments
22-B10512
When a Premarket Notification Submission Is Required
22-B10513
Exemption From Premarket Notification
22-B10514
Information Required in a Premarket Modification Submission
22-B10515
Format of a Premarket Notification Submission
22-B10516
Content and Format of a 21 U.S.C. § 360(k) Summary
22-B10517
Content and Format of a 21 U.S.C. § 360(k) Statement
22-B10518
Format of a Class III Certification
22-B10519
Confidentiality of Information
22-B10520
Misbranding by Reference to Premarket Notification
22-B10521
Department of Health Action on a Premarket Notification
22-B10599
Definitions