5559475 Health, Department of - Notice of Proposed Rulemaking - Amending Chapter 102 to include importers and vendors of medical devices under licensing and regulation

DEPARTMENT OF HEALTH

 

NOTICE OF PROPOSED RULEMAKING

 

The Director of the Department of Health, pursuant to the authority set forth in Sections 4902(a)(8) and 4908 of the Department of Health Functions Clarification Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code §§ 7-731(a)(8) and 7-737 (2012 Repl. & 2014 Supp.)); and Mayor’s Order 2006-34, dated March 12, 2006, hereby gives notice of intent to amend Chapter 102 (Licensing of Medical Device Distributors and Manufacturers) of Title 22 (Health), Subtitle B (Public Health and Medicine) of the District of Columbia Municipal Regulations (DCMR). 

 

Section 4902(a)(8) of the Department of Health Functions Clarification Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731(a)(8) (2012 Repl. & 2014 Supp.)) requires the Department of Health to regulate medical devices in the District of Columbia.  The Notice of Final Rulemaking published on July 12, 2013 in the D.C. Register at 60 DCR 10252 only required manufacturers and distributors to be licensed and regulated by the Department of Health.  However, there are four business entities that are involved in the supply of medical devices in the District of Columbia – manufacturers, distributors, importers, and vendors.  The Department of Health proposes to regulate all of these entities to ensure that the medical devices placed in the stream of commerce in the District of Columbia are safe and effective. The purpose of these amendments is to require importers and vendors of medical devices to be licensed and regulated as are manufacturers and distributors.  In addition, this rulemaking will define the terms “importer” and “vendor.”  

 

Final rulemaking action to adopt these amendments shall be taken in not less than thirty (30) days from the date of publication of this notice in the D.C. Register. 

 

Chapter 102, LICENSING OF MEDICAL DEVICE DISTRIBUTORS AND MANUFACTURERS, of Title 22-B DCMR, PUBLIC HEALTH AND MEDICINE, is amended as follows:

 

Amend the Chapter 102 heading to read as follows:

 

CHAPTER 102  LICENSING OF MEDICAL DEVICES - DISTRIBUTORS,

MANUFACTURERS, IMPORTERS, AND VENDORS

 

Section 10200, GENERAL PROVISIONS, is amended as follows:

 

Subsection 10200.1 is amended to read as follows:

 

10200.1          These sections provide for the minimum licensing standards necessary to ensure the safety and efficacy of medical devices placed in the stream of commerce by distributors, manufacturers, importers, and vendors.

 

Section 10203, LICENSURE REQUIREMENTS, is amended as follows:

 

Subsection 10203.1 is amended to read as follows:

 

10203.1           Except as provided by § 10202, a person may not engage in the distribution, manufacturing, importation, or vending of medical devices in the District of Columbia unless the person has a valid license from the Department of Health for each place of business.

 

Subsection 10203.3 is amended to read as follows:

 

10203.3           Each person involved in the distribution, manufacturing, importation, or vending of medical devices in the District of Columbia on the effective date of these sections shall apply for a device distributor, manufacturer, importer, or vendor license no later than sixty (60) days following the effective date of these regulations.

 

Subsection 10203.4 is amended to read as follows:

 

10203.4           Each person acquiring or establishing a place of business for the purpose of medical device distribution, manufacturing, importation, or vending after the effective date of these sections shall apply to the Department for a license prior to beginning operation.

 

Subsection 10203.5 is amended to read as follows:

 

10203.5           If the medical device distributor, manufacturer, importer, or vendor operates more than one place of business, the medical device distributor, manufacturer importer, or vendor shall obtain a license for each place of business.

 

Subsection 10203.6 is amended to read as follows:

 

10203.6           The Department may license a distributor, manufacturer, importer, or vendor of medical devices who meets the requirements of these sections and pays all fees.

 

Subsection 10203.14 is amended to read as follows:

 

10203.14         If the United States Food and Drug Administration (FDA) or the Department determines, with respect to a product that is a combination of a drug and a medical device, that the primary mode of action of the product is as a device, a distributor, manufacturer, importer, or vendor of the product is subject to licensure as described in this section.

 

Section 10204, LICENSING PROCEDURES, is amended as follows:

 

Subsection 10204.2 is amended to read as follows:

 

10204.2           The application for licensure as a medical device distributor, manufacturer, importer, or vendor shall be signed and verified, and submitted on a license application form furnished by the Department.

 

Section 10207, REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE, is amended as follows:

 

Subsection 10207.3 is amended to read as follows:

 

10207.3           The Department may, after providing opportunity for a hearing, refuse to license a distributor, manufacturer, importer, or vendor of medical devices, or may suspend or revoke a license for violations of the laws and regulations listed in § 10201.1 or for any of the reasons described in the Act.

 

Subsection 10207.4 is amended to read as follows:

 

10207.4           A license issued under this chapter shall be returned to the Department if the medical device distributor, manufacturer, importer, or vendor’s place of business:

 

(a)        Ceases business or otherwise ceases operation on a permanent basis;

 

(b)       Relocates; or

 

(c)        Is deemed, as a corporation, to have undergone an ownership change as determined by a transfer of five percent (5%) or more of the share of stock from one person to another.

 

Section 10208, MINIMUM STANDARDS FOR LICENSURE, is amended as follows:

 

Subsection 10208.1 is amended to read as follows:

 

10208.1           All medical device distributors, manufacturers, importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of devices shall comply with the minimum standards of this section. 

 

Subsection 10208.3 is amended to read as follows:

 

10208.3           All persons who operate as medical device distributors, manufacturers,             importers, or vendors in the District of Columbia shall meet the applicable requirements in Chapter 105, titled “Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices.”  Medical devices medical distributed by device distributors, manufacturers, importers, or vendors shall meet, if applicable, the premarket notification requirements of Chapter 105 of this subtitle or the premarket approval provisions of Chapter 106 of this subtitle, titled “Premarket Approval of Medical Devices.”

 

Subsection 10208.4 is amended to read as follows:

 

10208.4           Medical device distributors, manufacturers, importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of finished medical devices shall be in compliance with the applicable requirements of Chapter 107 of this subtitle, entitled “Quality System Regulation.”  The requirements in this section govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of all finished medical devices intended for human use. 

 

Subsection 10208.6 is amended to read as follows:

 

10208.6           No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of medical devices by distributors, manufacturers, importers, or vendors shall be conducted in any personal residence.       

 

Subsection 10208.8 is amended to read as follows:

 

10208.8           All medical devices stored by distributors, manufacturers, importers, or vendors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such medical devices.

 

Subsection 10208.9 is amended to read as follows:

 

10208.9           Medical devices distributed by device distributors, manufacturers, importers, or vendors shall meet the labeling requirements of Chapter 103 of this subtitle.

 

Subsection 10208.12 is amended to read as follows:

 

10208.12         Medical device distributors, manufacturers, importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.

 

Subsection 10208.13 is amended to read as follows:

 

10208.13         Medical devices which emit electronic product radiation and are distributed by medical device distributors, manufacturers, importers, or vendors shall meet the applicable requirements of Chapter 108 entitled of this subtitle.

 

Subsection 10208.14 is amended to read as follows:

 

10208.14         A prescription medical device in the possession of a medical device distributor, manufacturer, importer, or vendor licensed under these sections of this subchapter shall be exempt from 21 U.S.C. § 352(f)(1) relating to labeling bearing adequate directions for use, providing it meets the requirements of § 10310 and § 10311 of this subtitle.

 

Subsection 10208.15 is amended to read as follows:

 

10208.15         Each medical device distributor, manufacturer, importer, or vendor who distributes prescription medical devices shall maintain a record for every prescription medical device, showing the identity and quantity received or manufactured and the disposition of each device.

 

Subsection 10208.16 is amended to read as follows:

 

10208.16         Each medical device distributor, manufacturer, importer, or vendor who delivers a prescription medical device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.

 

A new Section 10299 is added to read as follows:

 

10299             DEFINITIONS

 

10299.1           As used in this chapter, the following term shall have the meaning ascribed:

                   

Importer – any person who brings a medical device into the District of Columbia from another state or territory for the purpose of sale or use.

 

Vendor – any person engaged in selling medical devices for the immediate delivery upon purchase.

 

 

All persons desiring to comment on the subject matter of this proposed rulemaking should file comments in writing not later than thirty (30) days after the date of the publication of this notice in the D.C. Register.  Comments should be sent in writing to Van Brathwaite, Department of Health, 899 North Capitol Street, N.E., 2^nd Floor, Washington, D.C., 20002 or [e-mail].  Copies of the proposed rules may be obtained from the Department at the same address during the hours of 9 a.m. to 5 p.m., Monday through Friday, excluding holidays.  Requests may be communicated by calling [phone] or addressing emails to [e-mail].