[Federal Register Volume 69, Number 249 (Wednesday, December 29, 2004)]
[Rules and Regulations]
[Pages 77898-77900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28437]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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