[Federal Register: December 29, 2004 (Volume 69, Number 249)]
[Rules and Regulations]
[Page 77898-77900]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de04-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 870 and 882
[Docket No. 2003N-0567]
Cardiovascular and Neurological Devices; Reclassification of Two
Embolization Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to reclassify two embolization device types from class III (premarket
approval) into class II (special controls). The agency is also changing
the names and revising the identifications of these devices. The
vascular embolization device (previously the arterial embolization
device) is intended to control hemorrhaging due to aneurysms, certain
types of tumors, and arteriovenous malformations. The neurovascular
embolization device (previously the artificial embolization device) is
intended to permanently occlude blood flow to cerebral aneurysms and
cerebral arteriovenous malformations. FDA is reclassifying these
devices on its own initiative on the basis of new information. FDA is
taking this action under the Federal Food, Drug, and Cosmetic Act (the
act), as amended by the Medical Device Amendments of 1976 (the 1976
amendments), the Safe Medical Devices Act of 1990, the Food and Drug
Administration Modernization Act of 1997, and the Medical Device User
Fee and Modernization Act of 2002.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document that will serve as the
special control for these devices.
DATES: This rule is effective January 28, 2005.
FOR FURTHER INFORMATION CONTACT: Peter L. Hudson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
The act (21 U.S.C. 301 et seq.) established a comprehensive system
for the regulation of medical devices intended for human use. Section
513 of the act (21 U.S.C. 360c) established three categories (classes)
of devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
Under section 513 of the act, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the agency initiates the following procedures: (1)
Receives a recommendation from a device classification panel (an FDA
advisory committee); (2) publishes the panel's recommendation for
comment, along with a proposed regulation classifying the device; and
(3) publishes a final regulation classifying the device. FDA has
classified most preamendments devices under these procedures. FDA
refers to devices that were not in commercial distribution before May
28, 1976, as ``postamendments devices.''
These devices are classified automatically by statute (section
513(f) of the act) into class III without any FDA rulemaking process.
The devices remain in class III and require premarket approval, unless
FDA initiates the following procedures: (1) Reclassifies the device
into class I or II; (2) issues an order classifying the device into
class I or II in accordance with section 513(f)(2) of the act; or (3)
issues, under section 513(i) of the act, an order finding the device
substantially equivalent to a predicate device that does not require
premarket approval. As described in section 510(k) of the act (21
U.S.C. 360(k)) and under part 807 of the regulations (21 CFR part 807),
FDA determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures.
Through premarket notification procedures, a person may, without
submission of a premarket approval application (PMA), market a
preamendments device that has been classified into class III until FDA
issues a final regulation under section 515(b) of the act (21 U.S.C.
360e(b)) requiring premarket approval.
Section 513(e) of the act addresses the reclassification of
classified devices. This section provides that FDA may, by rulemaking,
reclassify a device based on ``new information.'' Under section 513(e)
of the act, FDA can initiate reclassification or an interested person
can petition FDA to reclassify a preamendments device. The term ``new
information,'' as used in section 513(e) of the act, includes
information developed after the date of the device's original
classification. This information could include a reevalution of the
original data or information from the time of the device's original
classification that was not presented, available, or developed at that
time. (See, e.g., Holland Rantos v. United States Department of Health,
Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978);
Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously used by FDA is an appropriate
basis for subsequent regulatory action where the reevaluation is made
in light of newly available regulatory authority (see Bellv. Goddard,
supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 389-91
(D.D.C. 1991)), or in light of changes in ``medical science.'' (See
Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data before FDA are
past or new data, the ``new information'' to support reclassification
under section 513(e) of the act must be ``valid scientific evidence,''
as defined in section 513(a)(3) of the act and 21 CFR 860.7(c)(2).
(See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985);
Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474
U.S. 1062 (1985).) FDA relies upon ``valid scientific evidence'' in the
classification process to determine the level of regulation for
devices. When reclassifying a device, FDA can only consider valid
scientific evidence that is publicly available. Publicly available
information excludes trade secret and confidential commercial
information, e.g., the contents of a pending PMA. (See section 520(c)
of the act (21 U.S.C. 360j(c).)
II. Regulatory History of the Devices
In the Federal Register of February 25, 2004 (69 FR 8600), FDA
issued a proposed rule to change the names, revise the identifications,
and reclassify the two devices from class III (premarket
[[Page 77899]]
approval) into class II (special controls). FDA identified the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Vascular and Neurovascular Embolization Devices'' as the
proposed special control capable of providing of providing reasonable
assurance of the safety and effectiveness for these devices. The
vascular embolization device (previously the arterial embolization
device) is intended to control hemorrhaging due to aneurysms, certain
types of tumors, and arteriovenous malformations. The neurovascular
embolization device (previously the artificial embolization device) is
intended to permanently occlude blood flow to cerebral aneurysms and
cerebral arteriovenous malformations. FDA invited interested persons to
comment on the proposed rule by May 25, 2004. FDA received one comment.
The comment was supportive of the proposed reclassification but made
suggestions on the guidance document's content. FDA considered the
suggestions and made appropriate revisions to the guidance document.
III. Conclusion
Based on the information discussed in the preamble to the proposed
rule, FDA concludes that special controls, in conjunction with general
controls, will provide reasonable assurance of the safety and
effectiveness for these devices. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of the guidance document
entitled ``Class II Special Controls Guidance Document: Vascular and
Neurovascular Embolization Devices'' as the guidance document that will
serve as the special control for these devices. FDA believes that this
special controls guidance document in addition to the general controls
will provide reasonable assurance of the safety and effectiveness of
these devices. Following the effective date of this rule, any firm
submitting a 510(k) submission for these embolization devices will need
to address the issues covered in the class II special controls guidance
document. However, the firm need only show that its device meets the
recommendations of the class II special controls guidance document or
in some other way provides equivalent assurances of safety and
effectiveness.
In addition to reclassifying these devices from class III into
class II, FDA has revised the name and identification of 21 CFR parts
870.330 and 882.5950. FDA believes that renaming the arterial
embolization device as the ``vascular embolization device'' and the
artificial embolization device as the ``neurovascular embolization
device'' more accurately reflect the intended uses of these devices.
Section 870.1(e) (21 CFR 870.1(e)), which was included in the
proposed rule, was previously added by a final rule published in the
Federal Register of October 28, 2003 (68 FR 61342). Section 882.1(e)
(21 CFR 882.1(e)), which was included in the proposed rule, was
previously added by a final rule published in the Federal Register of
December 18, 2003 (68 FR 70435).
IV. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et. seq.).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of these devices from class III
into class II will relieve all manufacturers of the devices of the cost
of eventually complying with the premarket approval requirements in
section 515 of the act. Because reclassification will therefore reduce
the regulatory costs associated with these devices and may permit small
potential competitors to enter the marketplace by lowering their costs,
the agency certifies that this final rule will not have a significant
economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, proposing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $110
million. FDA does not expect this final rule to result in any 1-year
expenditure that would meet or exceed this amount.
VI. Federalism
FDA has analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, FDA has concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule does not contain information collection provisions
that are subject to review by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
List of Subjects in 21 CFR Parts 870 and 882
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
870 and 882 are amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 870.3300 is revised to read as follows:
Sec. 870.3300 Vascular embolization device.
(a) Identification. A vascular embolization device is an
intravascular implant intended to control hemorrhaging due to
aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine
fibroids), and arteriovenous malformations. This does not include
cyanoacrylates and other embolic agents, which act by polymerization or
precipitation. Embolization devices used in neurovascular applications
are also not
[[Page 77900]]
included in this classification, see Sec. 882.5950 of this chapter.
(b) Classification. Class II (special controls.) The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Vascular and Neurovascular
Embolization Devices.'' For availability of this guidance document, see
Sec. 870.1(e).
PART 882--NEUROLOGICAL DEVICES
0
3. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
4. Section 882.5950 is revised to read as follows:
Sec. 882.5950 Neurovascular embolization device.
(a) Identification. A neurovascular embolization device is an
intravascular implant intended to permanently occlude blood flow to
cerebral aneurysms and cerebral ateriovenous malformations. This does
not include cyanoacrylates and other embolic agents, which act by
polymerization or precipitation. Embolization devices used in other
vascular applications are also not included in this classification, see
Sec. 870.3300.
(b) Classification. Class II (special controls.) The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Vascular and Neurovascular
Embolization Devices.'' For availability of this guidance document, see
Sec. 882.1(e).
Dated: December 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28437 Filed 12-28-04; 8:45 am]
BILLING CODE 4160-01-S