[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.2]
[Page 55-57]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 3 PRODUCT JURISDICTION--Table of Contents
Subpart A Assignment of Agency Component for Review of Premarket
Applications
Sec. 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,
[[Page 56]]
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) Mode of action is the means by which a product achieves an
intended therapeutic effect or action. For purposes of this definition,
``therapeutic'' action or effect includes any effect or action of the
combination product intended to diagnose, cure, mitigate, treat, or
prevent disease, or affect the structure or any function of the body.
When making assignments of combination products under this part, the
agency will consider three types of mode of action: The actions provided
by a biological product, a device, and a drug. Because combination
products are comprised of more than one type of regulated article
(biological product, device, or drug), and each constituent part
contributes a biological product, device, or drug mode of action,
combination products will typically have more than one identifiable mode
of action.
(1) A constituent part has a biological product mode of action if it
acts by means of a virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or analogous
product applicable to the prevention, treatment, or cure of a disease or
condition of human beings, as described in section 351(i) of the Public
Health Service Act.
(2) A constituent part has a device mode of action if it meets the
definition of device contained in section 201(h)(1) to (h)(3) of the
act, it does not have a biological product mode of action, and it does
not achieve its primary intended purposes through chemical action within
or on the body of man or other animals and is not dependent upon being
metabolized for the achievement of its primary intended purposes.
(3) A constituent part has a drug mode of action if it meets the
definition of drug contained in section 201(g)(1) of the act and it does
not have a biological product or device mode of action.
(l) 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).
(m) Primary mode of action is the single mode of action of a
combination product that provides the most important therapeutic action
of the combination product. The most important therapeutic action is the
mode of action expected to make the greatest contribution to the overall
intended therapeutic effects of the combination product.
(n) 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)).
(o) 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.
[[Page 57]]
(p) Sponsor means ``applicant'' (see Sec. 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; 70 FR 49861, Aug. 25,
2005]
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