[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Notices]
[Page 16311-16312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr08-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0180]
Draft Guidance for Industry on Coronary Drug Eluting Stents-
Nonclinical and Clinical Studies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Coronary Drug
Eluting Stents--Nonclinical and Clinical Studies.'' This draft guidance
is intended to provide recommendations to sponsors or applicants
planning to develop, or to submit to FDA, a marketing application for a
coronary drug eluting stent (DES). The draft guidance discusses the
clinical studies that should be performed and the data that should be
submitted to support such an application. The draft guidance is being
issued in two parts. The companion document provides additional and
more detailed guidance on some of the recommendations included in this
document. The companion document is intended to be used together with
this draft guidance.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 25, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to
[[Page 16312]]
http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-4222, or
Devi Kozeli, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4183, Silver
Spring, MD 20903-0002, 301-796-1128.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Coronary Drug Eluting Stents--Nonclinical and Clinical
Studies.'' Coronary stents are implantable devices that are placed
percutaneously in one or more coronary arteries to maintain patency. As
defined by section 503(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(g)), DESs are considered combination products because
they are a combination of two different types of regulated components
(a device and a drug) that are physically and/or chemically combined
and produced as a single entity (21 CFR 3.2(e)(1)). A combination
product is assigned to an agency component, such as the Center for
Devices and Radiological Health (CDRH) or the Center for Drug
Evaluation and Research (CDER) for premarket review and regulation
based on a determination of the product's primary mode of action. In
response to several requests for designation under 21 CFR 3.7, the
agency determined that the primary mode of action for current DESs is
that of the device component in maintaining coronary artery patency;
the drug component plays a secondary role in preventing restenosis,
augmenting the safety and/or effectiveness of the uncoated (bare)
stent.\1\ Therefore, the premarket review and regulatory responsibility
has been assigned to CDRH. Nevertheless, careful consideration should
be given to characterizing the drug component of DESs. This draft
guidance is intended to provide recommendations on meeting the
regulatory requirements for both the drug and device components of a
DES.
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\1\ See ``Jurisdictional Update: Drug-Eluting Cardiovascular
Stents,'' http://www.fda.gov/oc/combination/stents.html. This
Jurisdictional Update is applicable to DESs for which the primary
mode of action is the device component in maintaining vessel
patency. However, a DES for which the primary mode of action is
attributable to the drug component would be assigned to CDER.
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DESs incorporate a pharmacologically active agent (drug) that is
delivered at the site of stent deployment to reduce the incidence of
restenosis due to neointimal hyperplasia associated with bare metal
stenting. In many cases, the drug is incorporated into and released
from a polymeric coating of sufficient capacity to accommodate the
selected dose and to modulate its delivery at the intended site of
action and for the intended duration. The chemical, physical, and
mechanical attributes of the polymer coating system are important for
stent deployment, biocompatibility, and stability. To perform a
regulatory assessment of a DES, FDA must review data from a
comprehensive evaluation of individual components (drug, polymer, and
stent), as well as from a comprehensive evaluation of the finished
drug-device combination product.
This draft guidance clarifies a number of issues related to the
development DESs including the following.
How to characterize the drug substance, including
chemistry, nonclinical systemic and local tissue pharmacology and
toxicology, and how to evaluate potential for and consequences of
systemic clinical exposure.
How to characterize the drug-device combination product,
including the chemical/physical/mechanical properties of the DES, the
nonclinical local vascular and regional myocardial toxicology, and the
clinical performance of the drug-stent combination.
Regulatory considerations that are unique to DES
combination products.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 211 (current good
manufacturing practice for finished pharmaceuticals) have been approved
under OMB control number 0910-0139. The collections of information in
21 CFR parts 312 (investigational new drug application) and 314
(applications for FDA approval to market a new drug) have been approved
under OMB control numbers 0910-0014 and 0910-0001. The collections of
information in FDA's medical devices regulations in 21 CFR parts 801
(labeling), 803 (medical device reporting), 812 (investigational device
exemptions), 814 (premarket approval of medical devices), and 820
(quality system regulation) have been approved under OMB control
numbers 0910-0485, 0910-0437, 0910-0078, 0910-0231, and 0910-0073.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.
Dated: March 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6210 Filed 3-26-08; 8:45 am]
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