Section 22-B10700. SCOPE

 

10700.1Current 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, storage, installation, and servicing of all finished devices intended for human use. The requirements in this chapter are intended to ensure that finished devices will be safe and effective and otherwise in compliance with District regulations. This chapter establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this chapter, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in § 10705(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to 21 C.F.R., part 606 or its Department of Health equivalent.  Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 21 C.F.R. § 1271.3(d), that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions or under a biological product license application under the federal Public Health Service Act, 42 U.S.C. § 262 are subject to this chapter and are also subject to the donor-eligibility procedures set forth in 21 C.F.R., part 1271, subpart C and applicable current good tissue practice procedures in 21 C.F.R., part 1271, subpart D. In the event of a conflict between applicable regulations, the regulation specifically applicable to the device in question shall supersede the more general.

 

10700.2The provisions of this chapter shall be applicable to any finished device as defined in this chapter, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the U.S., the District of Columbia, or the Commonwealth of Puerto Rico.

 

10700.3In this regulation the term "where appropriate" is used several times.  When a requirement is qualified by "where appropriate," it is deemed to be "appropriate" unless the manufacturer can document justification otherwise. A requirement is "appropriate" if non-implementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.

 

10700.4The quality system regulation in this chapter supplements regulations in other sections in this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this chapter and in other sections in this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.

 

10700.5The failure to comply with any applicable provision in this chapter renders a device adulterated under 21 U.S.C. § 351. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.
 

10700.6If a manufacturer who offers devices for import into the U.S. refuses to permit or allow the completion of a Department inspection of the foreign facility for the purpose of determining compliance with this chapter, it shall appear for purposes of Chapter 103, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for  import into the U.S. do not conform to the requirements of 21 U.S.C. § 351j(f) and this section and that the devices manufactured at that facility are adulterated under 21 U.S.C. § 351(h).
 

10700.7Any person who wishes to petition for an exemption or variance from any device quality system requirement must submit a petition for an exemption or variance according to the Department’s administrative procedures.

 

10700.8The Department may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.

 

 

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.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).