Statutes, codes, and regulations
District Of Columbia Administrative Code
Title 22 - HEALTHSubtitle 22-B - PUBLIC HEALTH AND MEDICINE
Chapter 22-B105 - ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
Rule 22-B10513 - EXEMPTION FROM PREMARKET NOTIFICATION

D.C. Mun. Regs. tit. 22, r. 22-B10513

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Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10513 - EXEMPTION FROM PREMARKET NOTIFICATION
10513.1

A device is exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if the device intended for introduction into commercial distribution is not generally available in finished form for purchase and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and the device meets one (1) of the following conditions:

(a) It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or
(b) It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).
10513.2

A distributor who places a device into commercial distribution for the time under his own name and a re-packager who places his or her own name on a device and does not change any other labeling or otherwise affect the device shall be exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if:

(a) The device was in commercial distribution before May 28, 1976; or
(b) Another person filed the premarket notification on submission.

D.C. Mun. Regs. tit. 22, r. 22-B10513

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)
Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.