10601. PURPOSE

10601 PURPOSE 10601.1 The purpose of this part is to establish an efficient and thorough device review process that will: Facilitate the approval of PMAs for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and (b) Ensure the disapproval of PMAs for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10601