District of Columbia Administrative Code

10509 MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER 10509.1 Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates a…

10510 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES 10510.1 Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered fo…

10511 EXEMPTIONS FOR DEVICE ESTABLISHMENTS 10511.1 The following classes of persons are exempt from registration in accordance with § 10500 in accordance with the provisions of 21 U.S.C. § 360 (g)(1), (g)(2), and g(3) because such registration is not necessary for the protection …

10512 WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED 10512.1 Except as provided otherwise, each person who is required to register his or her establishment pursuant to § 10500 must submit a premarket notification submission to the Department at least ninety (90) days before…

10513 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 offer…

10514 INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION 10514.1 Each premarket notification submission shall contain the following information: (a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the d…

10515 FORMAT OF A PREMARKET NOTIFICATION SUBMISSION 10515.1 Each premarket notification submission pursuant to this chapter shall be submitted in accordance with this section. Each submission shall: Be addressed to the Department of Health, 899 North Capitol Street, NE, Washingto…

10516 CONTENT AND FORMAT OF A 21 U.S.C. § 360(k) SUMMARY 10516.1 A 21 U.S.C. § 360(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. The Department will accept summaries as well as amendments thereto …

10517 CONTENT AND FORMAT OF A 21 U.S.C. § 360(k) STATEMENT 10517.1 A 21 U.S.C. § 360(k) statement submitted as part of a premarket notification shall state as follows: “I certify that, in my capacity as (the position held in company by person required to submit the premarket noti…

10518 FORMAT OF A CLASS III CERTIFICATION 10518.1 A class III certification submitted as part of a premarket notification shall state as follows: “I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all informat…

10519 CONFIDENTIALITY OF INFORMATION 10519.1 The Department will disclose publicly whether there exists a premarket notification submission under this part: (a) Where the device is on the market (such as, introduced or delivered for introduction into interstate commerce for comme…

10520 MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION 10520.1 Submission of a premarket notification in accordance with this subsection, and a subsequent determination by the Department that the device intended for introduction into commercial distribution is substantially equ…

10521 DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION 10521.1 After review of a premarket notification, the Department will: Issue an order declaring the device to be substantially equivalent to a legally marketed predicate device; Issue an order declaring the device to b…

10599 DEFINITIONS 10599.1 As used in this chapter, the following terms shall have the meanings ascribed: 21 U.S.C. § 360(k) summary – a summary of any information respecting safety and effectiveness. A summary of the safety and effectiveness information contained in a premarket n…

10600 SCOPE 10600.1 This section provides procedures for the premarket approval of medical devices intended for human use. 10600.2 This section applies to any class III medical device, unless exempt under 21 U.S.C. § 360j, that: Was not on the market (introduced or delivered for …

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)…

10602 CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE 10602.1 A premarket approval application file (PMA file) includes all data and information submitted with or incorporated by reference in the PMA, any investigational device exemption (ID…

10603 RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES 10603.1 A study conducted outside of the United States (U.S.) submitted in support of a PMA and conducted under an IDE shall comply with 21 C.F.R. § 812. A study conducted outside of the U.S. submitted in support of a PMA and …

10604 SERVICE OF ORDERS 10604.1 Orders issued under this subsection will be served in person by a designated officer or employee of the Department on, or by registered mail to, the applicant or the designated agent at the applicant's or designated agent's last known address in th…

10605 PRODUCT DEVELOPMENT PROTOCOL (PDP) 10605.1 A class III device for which a product development protocol (PDP) has been declared completed by the Department under this chapter will be considered to have an approved PMA. SOURCE: Final Rulemaking published at 60 DCR 10252 (July…

10606 APPLICATION 10606.1 The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of bus…

10607 PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION 10607.1 An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information. 10607.2 The Department may request the applicant to amen…

10608 PREMARKET APPROVAL APPLICATION SUPPLEMENTS 10608.1 After the Department's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by the Department before making a change affecting the safety or effectiveness of the device for which the applica…

10609 TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION 10609.1 Within one hundred eighty (180) days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, the Department will review the PMA and, after rec…

10610 FILING A PREMARKET APPROVAL APPLICATION 10610.1 The filing of an application means that the Department has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within forty five (45) days the Department receives a PMA,…

10611 PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION 10611.1 The Department will begin substantive review of a PMA after the PMA is accepted for filing under § 10610. The Department may refer the PMA to a panel on its own initiative, and will do so upon request of an a…

10612 DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION 10612.1 The Department may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this section or if, upon the basis of the information submitted in the PMA or any other informatio…

10613 WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION 10613.1 The Department may issue an order withdrawing approval of a PMA if, from any information available to the agency, the Department determines that: Any of the grounds under 21 U.S.C. §§ 360e(e)(1) (A)-(G) appl…

10614 TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION 10614.1 This section describes the procedures that the Department will follow in exercising its authority under 21 U.S.C. § 360c(e)(3). This authority applies to the original PMA, as well as any PMA supple…

10615 GENERAL 10615.1 A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device. SOURCE: Final Rulemaking published at 60 DCR 10252 (J…

10616 POST-APPROVAL REQUIREMENTS 10616.1 The Department may impose post-approval requirements in a PMA approval order or regulation at the time of approval of the PMA or by regulation subsequent to approval. Post-approval requirements may include as a condition to approval of the…

10617 REPORTS 10617.1 The holder of an approved PMA shall comply with the requirements in Chapter 104 and with any other requirements applicable to the device by other regulations in this section or by order approving the device. 10617.2 Unless the Department specifies otherwise,…

10618 PURPOSE AND SCOPE 10618.1 The purpose of this section is, to the extent consistent with the protection of the public health and safety and with ethical standards, to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of dis…

10619 DESIGNATION OF HUMANITARIAN USE DEVICES STATUS 10619.1 Prior to submitting an HDE application, the applicant shall submit a request for humanitarian use devices (HUD) designation to the Department. The request shall contain the following: A statement that the applicant requ…

10620 ORIGINAL APPLICATIONS 10620.1 The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the U.S., the HDE shall be countersigned by an authorized representative residing or maintaining a place of bu…

10621 HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS 10621.1 An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of DOH, for the same reasons and in the same manner as prescribed for…

10622 SUPPLEMENTAL APPLICATIONS 10622.1 After the Department’s approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMAs under § 10608, except that a request for a new indication for use of a HUD shall comply with requirements…

10623 NEW INDICATIONS FOR USE 10623.1 An applicant seeking a new indication for use of a HUD approved under this section shall obtain a new designation of HUD status in accordance with § 10619 and shall submit an original HDE in accordance with § 10620. 10623.2 An application for…

10624 FILING A HUMANITARIAN DEVICE EXEMPTION 10624.1 The filing of an HDE means that the Department has made a threshold determination that the application is sufficiently complete to permit substantive review. Within thirty (30) days from the date an HDE is received by the Depar…

10625 TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION 10625.1 Within seventy-five (75) days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, the Department will send the applicant an approval order, an app…

10626 PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION 10626.1 The Department will begin substantive review of an HDE after the HDE is accepted for filing under § 10624. The Department may refer an original HDE application to a panel on its own initiative, and shall do so…

10627 DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION 10627.1 The Department may deny approval or withdraw approval of an application if the applicant fails to meet the requirements of 21 U.S.C. § 360j(m) or of any condition of approval imposed by …

10628 TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION 10628.1 An HDE or HDE supplement may be temporarily suspended for the same reasons and in the same manner as prescribed for PMAs in § 10614. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013…

10629 CONFIDENTIALITY OF DATA AND INFORMATION 10629.1 The "HDE file" includes all data and information submitted with or referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or supplement, any report submitted under § 10631, any master file, or any other re…

10630 [RESERVED] SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10630 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1…

10631 INSTITUTIONAL REVIEW BOARD REQUIREMENTS 10631.1 The HDE holder is responsible for ensuring that a HUD approved under this section is administered only in facilities having an IRB constituted and acting pursuant to these regulations, including continuing review of use of the…

10632 POST-APPROVAL REQUIREMENTS AND REPORTS 10632.1 An HDE approved under this section shall be subject to the post-approval requirements and reports set forth under 21 C.F.R. § 1.83, et seq., as applicable, with the exception of § 10616.1(g). In addition, medical device reports…

10699 DEFINITIONS 10699.1 As used in this chapter, the following terms shall have the meanings ascribed: Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, (31 U.S.C. § 301, et seq.) Humanitarian Device Exemption (HDE) – an application that is similar to a pr…

10700 SCOPE 10700.1 Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this chapter govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storag…

10701 QUALITY SYSTEM 10701.1 Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this chapter. SOURCE: Final Rulemaking published at 60 DCR 10252 (July …