6136625 Health, Department of - Notice of Second Proposed Rulemaking - Amending Title 22-B to require initial importers and vendors of medical devices to be licensed and regulated as are manufacturers and distributors

  • DEPARTMENT OF HEALTH

    NOTICE OF SECOND 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. & 2016 Supp.)), and Mayor’s Order 2006-34, dated March 12, 2006, hereby gives notice of the intent to take rulemaking action to adopt the following amendments to Chapters 102 (Licensing of Medical Device Distributors and Manufacturers), 105 (Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices), and 106 (Premarket Approval of Medical Devices) of Title 22 (Health), Subtitle B (Public Health and Medicine) of the District of Columbia Municipal Regulations (DCMR), in not less than thirty (30) days after the date of publication of this notice in the D.C. Register.

     

    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. & 2016 Supp.)) authorizes 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, initial 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 initial importers and vendors of medical devices to be licensed and regulated as are manufacturers and distributors.  In addition, this rulemaking will define the terms “initial importer” and “vendor.”

     

    These amendments were published as Notice of Proposed Rulemaking in the D.C. Register on July 24, 2015 at 62 DCR 010043. The Department received two (2) comments from the Advanced Medical Technology Association.  They were as follows:

     

    Comment 1: The Association recommended that the definition of “vendor” and “importer” be modified to specifically exclude agents or representatives of licensed manufacturers and distributors.  The Association argued that as currently written, the proposed rule could be construed as requiring manufacturer and distributor sales representatives and agents to obtain vendor or importer licenses.  The Association also averred that as written, the rulemaking could cause confusion as to which licensees interface with the Department of Health.

     

    Comment 2: The Association recommended that the definition of “importer” should be modified to clarify that common carriers and delivery agents who do not take title or assume other ownership rights to medical devices are not required to be licensed.  The Association reasoned that the change would prevent common carriers and delivery agents from needing a license while engaged in the transportation of medical devices.

     

    After review of the comments, the Department determined that the requests are reasonable and has amended the definitions of “importer” and “vendor” to comport with the request. In addition, the term “initial importer” is being substituted for “importer” as “initial importer” appears in Chapter 105 (text).  The amended definitions were forwarded to the commenter.  The commenter is in agreement with the amended language.

     

    Title 22-B DCMR, PUBLIC HEALTH AND MEDICINE, is amended as follows:

     

    Chapter 102, LICENSING OF MEDICAL DEVICE DISTRIBUTORS AND MANUFACTURERS, is amended as follows:

     

    The Chapter 102 heading is amended to read as follows:

     

    CHAPTER 102         LICENSING OF MEDICAL DEVICES – DISTRIBUTORS,

    MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS

     

    Section 10200, GENERAL PROVISIONS, is amended as follows:

     

    Subsection 10200.1 is amended to read as follows:

     

    10200.1           These section 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, initial importers, and vendors.  

     

    Section 10203, LICENSURE REQUIREMENTS, is amended as follows:

     

    The section heading for 10203 is amended to read as follows:

     

    10203              LICENSURE REQUIREMENTS FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS

     

    Subsections 10203.1 to 10203.6 are amended to read as follows:

     

    10203.1           Except as provided by § 10202, a person may not engage in distributing, manufacturing, importing, or vending medical devices in the District of Columbia unless the person has a valid license from the Department of Health.  

     

    10203.2           The license shall be displayed in an open public area at each place of business.

     

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

     

     

    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 subsections shall apply to the Department for a license prior to beginning operation.

     

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

     

    10203.6           The Department may license a distributor, manufacturer, initial 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) 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, initial importer, or vendor of the product is subject to licensure as described in this section.     

     

    Section 10204, LICENSING PROCEDURES, is amended as follows:

     

    The section heading for 10204 is amended to read as follows:

     

    10204              LICENSING PROCEDURES FOR DISTRIBUTORS, MANUFACTURERS,

                            INITIAL IMPORTERS AND VENDORS

     

    Subsections 10204.1 and 10204.2 are amended to read as follows:

     

    10204.1           License application forms may be obtained from the Department at 899 North Capitol Street, N.E., Washington, D.C., or online at www.hpla.doh.dc.gov.

     

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

     

    Subsection 10204.4 is amended to read as follows:

     

    10204.4           A completed application shall entitle a medical device distributor, manufacturer, importer, or vendor to a license, except as provided in § 10207.

     

    A new Subsection 10204.5 is added to read as follows:

     

    10204.5           The renewal application for licensure as a medical device distributor, manufacturer, importer, or vendor shall be made on a license application form furnished by the Department. 

     

    Subsection 10204.6 is repealed.

     

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

     

    Subsections 10207.3 and 10207.4 are amended to read as follows:

     

    10207.3           The Department may, after providing opportunity for a hearing, refuse to license a distributor, manufacturer, initial importer, or vendor of medical devices, or may suspend or revoke a license, for any violation of the federal-law requirements incorporated into these regulations pursuant to § 10201.

     

    10207.4           A license issued under this chapter shall be returned to the Department if the medical device distributor, manufacturer, initial 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, initial importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and          vending of medical devices shall comply with the minimum standards of this section.

     

    Subsections 10208.3 and 10208.4 are repealed.

     

    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, initial 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, initial importers, or vendors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the label of such medical devices.

     

    Subsection 10208.9 is amended to read as follows:

     

    10208.9           Medical devices distributed by device distributors, manufacturers, initial 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, initial importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.

     

    Subsection 10208.14 is repealed and reserved.

     

    Subsection 10208.15 is amended to read as follows:

     

    10208.15         Each medical device distributor, manufacturer, initial 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, initial 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 meanings ascribed:

     

    Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package.  The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.

     

    Vendor – any person, with the exception of any agent or sale representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.

     

    Chapter 105, ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES, Section 10500, WHO MUST REGISTER AND SUBMIT A DEVICE LIST, is amended as follows:

     

    A new Subsection 10500.6 is added to read as follows:

     

    10500.6           For purposes of these chapters, the term “device(s)”, wherever it appears, shall mean “medical device(s).” 

     

    Section 10599, DEFINITIONS, Subsection 10599.1, is amended as follows:

     

    The following definition is amended:

     

    Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package.  The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.  

     

    The following definitions are added:

     

    Medical device – an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:

     

    (a)        Which is:

     

    (1)        Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;

     

    (2)        Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or

     

    (3)        Intended to affect the structure or any function of the body of man or other animals; and

     

    (b)        Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

     

    Vendor – any person, with the exception of an agent or sales representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.

     

    Chapter 106, PREMARKET APPROVAL OF MEDICAL DEVICES, Section 10699, DEFINITIONS, is amended as follows:

     

    Subsection 10699.1 is amended to include the following definition:

     

    Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package.  The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.

     

     

    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., 2nd Floor, Washington, D.C. 20002 or van.brathwaite@dc.gov.  Copies of the proposed rules may be obtained from the Department at the same address during the hours of 9:00 a.m. to 5 p.m., Monday through Friday, excluding holidays.  Requests may be communicated by calling (202) 442-5977 or addressing emails to angli.black@dc.gov