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Sec.
3.1 Purpose.
3.2
Definitions.
3.3 Scope.
3.4
Designated agency component.
3.5 Procedures for
identifying the designated agency component.
3.6 Product
jurisdiction officer.
3.7 Request for designation.
3.8
Letter of designation.
3.9 Effect of letter of designation.
3.10
Stay of review time.
Subpart B [Reserved]
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j,
360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262.
Source:
56 FR 58756, Nov. 21, 1991, unless otherwise noted.
§3.1 Purpose.
This regulation
relates to agency management and organization and has two purposes. The first
is to implement section 503(g) of the act, as added by section 16 of the Safe
Medical Devices Act of 1990 (Public Law 101-629) and amended by section 204
of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250),
by specifying how FDA will determine the organizational component within FDA
designated to have primary jurisdiction for the premarket review and regulation
of products that are comprised of any combination of a drug and a device; a
device and a biological; a biological and a drug; or a drug, a device and a
biological. This determination will eliminate, in most cases, the need to receive
approvals from more than one FDA component for such combination products. The
second purpose of this regulation is to enhance the efficiency of agency management
and operations by providing procedures for determining which agency component
will have primary jurisdiction for any drug, device, or biological product where
such jurisdiction is unclear or in dispute. Nothing in this section prevents
FDA from using any agency resources it deems necessary to ensure adequate review
of the safety and effectiveness of any product, or the substantial equivalence
of any device to a predicate device.
[56 FR 58756, Nov. 21, 1991, as amended
by 68 FR 37077, June 23, 2003]
§3.2 Definitions.
For
the purpose of this part:
(a) Act means the Federal Food, Drug, and Cosmetic
Act.
(b) Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, the Center for Drug
Evaluation and Research, or alternative organizational component of the agency.
(c) Applicant means any person who submits or plans to submit an application
to the Food and Drug Administration for premarket review. For purposes of this
section, the terms "sponsor" and "applicant" have the same
meaning.
(d) Biological product has the meaning given the term in section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
(e)
Combination product includes:
(1) A product comprised of two or more regulated
components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic,
that are physically, chemically, or otherwise combined or mixed and produced
as a single entity;
(2) Two or more separate products packaged together
in a single package or as a unit and comprised of drug and device products,
device and biological products, or biological and drug products;
(3) A drug,
device, or biological product packaged separately that according to its investigational
plan or proposed labeling is intended for use only with an approved individually
specified drug, device, or biological product where both are required to achieve
the intended use, indication, or effect and where upon approval of the proposed
product the labeling of the approved product would need to be changed, e.g.,
to reflect a change in intended use, dosage form, strength, route of administration,
or significant change in dose; or
(4) Any investigational drug, device,
or biological product packaged separately that according to its proposed labeling
is for use only with another individually specified investigational drug, device,
or biological product where both are required to achieve the intended use, indication,
or effect.
(f) Device has the meaning given the term in section 201(h)
of the act.
(g) Drug has the meaning given the term in section 201(g)(1)
of the act.
(h) FDA means Food and Drug Administration.
(i) Letter
of designation means the written notice issued by the product jurisdiction
officer specifying the agency component with primary jurisdiction for a combination
product.
(j) Letter of request means an applicant's written submission
to the product jurisdiction officer seeking the designation of the agency component
with primary jurisdiction.
(k) Premarket review includes the examination
of data and information in an application for premarket review described in
sections 505, 510(k), 513(f), 515, or 520(g) or 520(l) of the act or section
351 of the Public Health Service Act of data and information contained in any
investigational new drug (IND) application, investigational device exemption
(IDE), new drug application (NDA), biologics license application, device premarket
notification, device reclassification petition, and premarket approval application
(PMA).
(l) Product means any article that contains any drug as defined
in section 201(g)(1) of the act; any device as defined in section 201(h) of
the act; or any biologic as defined in section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)).
(m) Product jurisdiction officer is the person
or persons responsible for designating the component of FDA with primary jurisdiction
for the premarket review and regulation of a combination product or any product
requiring a jurisdictional designation under this part.
(n) Sponsor means
"applicant" (see §3.2(c)).
[56 FR 58756, Nov. 21, 1991 as
amended at 64 FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999; 68 FR 37077,
June 23, 2003]
§3.3 Scope.
This section applies to:
(a)
Any combination product, or
(b) Any product where the agency component with
primary jurisdiction is unclear or in dispute.
§3.4 Designated agency component.
(a)
To designate the agency component with primary jurisdiction for the premarket
review and regulation of a combination product, the agency shall determine the
primary mode of action of the product. Where the primary mode of action is that
of:
(1) A drug (other than a biological product), the agency component charged
with premarket review of drugs shall have primary jurisdiction;
(2) A device,
the agency component charged with premarket review of devices shall have primary
jurisdiction;
(3) A biological product, the agency component charged with
premarket review of biological products shall have primary jurisdiction.
(b)
The designation of one agency component as having primary jurisdiction for the
premarket review and regulation of a combination product does not preclude consultations
by that component with other agency components or, in appropriate cases, the
requirement by FDA of separate applications.
§3.5 Procedures for identifying the designated
agency component.
(a)(1) The Center for Biologics Evaluation and Research,
the Center for Devices and Radiological Health, and the Center for Drug Evaluation
and Research have entered into agreements clarifying product jurisdictional
issues. These guidance documents are on display in the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, and are entitled "Intercenter Agreement Between the Center for
Drug Evaluation and Research and the Center for Devices and Radiological Health;"
"Intercenter Agreement Between the Center for Devices and Radiological
Health and the Center for Biologics Evaluation and Research;" "Intercenter
Agreement Between the Center for Drug Evaluation and Research and the Center
for Biologics Evaluation and Research." The availability of any amendments
to these intercenter agreements will be announced by FEDERAL REGISTER notice.
(2) These guidance documents describe the allocation of responsibility for
categories of products or specific products. These intercenter agreements, and
any amendments thereto, are nonbinding determinations designed to provide useful
guidance to the public.
(3) The sponsor of a premarket application or required
investigational filing for a combination or other product covered by these guidance
documents may contact the designated agency component identified in the intercenter
agreement before submitting an application of premarket review or to confirm
coverage and to discuss the application process.
(b) For a combination product
not covered by a guidance document or for a product where the agency component
with primary jurisdiction is unclear or in dispute, the sponsor of an application
for premarket review should follow the procedures set forth in §3.7 to
request a designation of the agency component with primary jurisdiction before
submitting the application.
[56 FR 58756, Nov. 21, 1991, as amended at 68
FR 24879, May 9, 2003]
§3.6 Product jurisdiction
officer.
The Office of Combination Products (HFG-3), Food and Drug Administration,
15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 301-827-9229, e-mail:
combination@fda.gov, is the designated product jurisdiction officer.
[68
FR 37077, June 23, 2003]
§3.7 Request for designation.
(a)
Who should file: the sponsor of:
(1) Any combination product the sponsor
believes is not covered by an intercenter agreement; or
(2) Any product
where the agency component with primary jurisdiction is unclear or in dispute.
(b) When to file: a sponsor should file a request for designation before
filing any application for premarket review, whether an application for marketing
approval or a required investigational notice. Sponsors are encouraged to file
a request for designation as soon as there is sufficient information for the
agency to make a determination.
(c) What to file: an original and two copies
of the request for designation must be filed. The request for designation must
not exceed 15 pages, including attachments, and must set forth:
(1) The
identity of the sponsor, including company name and address, establishment registration
number, company contact person and telephone number.
(2) A description of
the product, including:
(i) Classification, name of the product and all
component products, if applicable;
(ii) Common, generic, or usual name of
the product and all component products;
(iii) Proprietary name of the product;
(iv) Identification of any component of the product that already has received
premarket approval, is marketed as not being subject to premarket approval,
or has received an investigational exemption, the identity of the sponsors,
and the status of any discussions or agreements between the sponsors regarding
the use of this product as a component of a new combination product.
(v)
Chemical, physical, or biological composition;
(vi) Status and brief reports
of the results of developmental work, including animal testing;
(vii) Description
of the manufacturing processes, including the sources of all components;
(viii)
Proposed use or indications;
(ix) Description of all known modes of action,
the sponsor's identification of the primary mode of action, and the basis for
that determination;
(x) Schedule and duration of use;
(xi) Dose and
route of administration of drug or biologic;
(xii) Description of related
products, including the regulatory status of those related products; and
(xiii)
Any other relevant information.
(3) The sponsor's recommendation as to which
agency component should have primary jurisdiction, with accompanying statement
of reasons.
(d) Where to file: all communications pursuant to this subpart
shall be addressed to the attention of the product jurisdiction officer. Such
a request, in its mailing cover should be plainly marked "Request for Designation."
Concurrent submissions of electronic copies of Requests for Designation may
be addressed to combination@fda.gov.
[56 FR 58756, Nov. 21, 1991, as amended
at 68 FR 37077, June 23, 2003]
§3.8 Letter of designation.
(a) Each request
for designation will be reviewed for completeness within 5 working days of receipt.
Any request for designation determined to be incomplete will be returned to
the applicant with a request for the missing information. The sponsor of an
accepted request for designation will be notified of the filing date.
(b)
Within 60 days of the filing date of a request for designation, the product
jurisdiction officer will issue a letter of designation to the sponsor, with
copies to the centers, specifying the agency component designated to have primary
jurisdiction for the premarket review and regulation of the product at issue,
and any consulting agency components. The product jurisdiction officer may request
a meeting with the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a letter of
designation within 60 days of the filing date of a request for designation,
the sponsor's recommendation of the center with primary jurisdiction, in accordance
with §3.7(c)(3), shall become the designated agency component.
(c)
Request for reconsideration by sponsor: If the sponsor disagrees with the designation,
it may request the product jurisdiction officer to reconsider the decision by
filing, within 15 days of receipt of the letter of designation, a written request
for reconsideration not exceeding 5 pages. No new information may be included
in a request for reconsideration. The product jurisdiction officer shall review
and act on the request in writing within 15 days of its receipt.
§3.9 Effect of letter of designation.
(a)
The letter of designation constitutes an agency determination that is subject
to change only as provided in paragraph (b) of this section.
(b) The product
jurisdiction officer may change the designated agency component with the written
consent of the sponsor, or without its consent to protect the public health
or for other compelling reasons. A sponsor shall be given 30 days written notice
of any proposed nonconsensual change in designated agency component. The sponsor
may request an additional 30 days to submit written objections, not to exceed
15 pages, to the proposed change, and shall be granted, upon request, a timely
meeting with the product jurisdiction officer and appropriate center officials.
Within 30 days of receipt of the sponsor's written objections, the product jurisdiction
officer shall issue to the sponsor, with copies to appropriate center officials,
a written determination setting forth a statement of reasons for the proposed
change in designated agency component. A nonconsensual change in the designated
agency component requires the concurrence of the Principal Associate Commissioner.
[56 FR 58756, Nov. 21, 1991, as amended at 68 FR 37077, June 23, 2003]
§3.10 Stay of review time.
Any filing
with or review by the product jurisdiction officer stays the review clock or
other established time periods for agency action for an application for marketing
approval or required investigational notice during the pendency of the review
by the product jurisdiction officer.
Subpart B [Reserved]