D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B106. PREMARKET APPROVAL OF MEDICAL DEVICES |
Section 22-B10600. SCOPE
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10600.1This section provides procedures for the premarket approval of medical devices intended for human use.
10600.2This section applies to any class III medical device, unless exempt under 21 U.S.C. § 360j, that:
(a) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II;
(b) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under 21 U.S.C. § 360e(b); or
(c) Was regulated by the Department as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by 21 U.S.C. § 360j(1).
10600.3This part amends the conditions to approval for any premarket approval (PMA) approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.