
[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]               
[Page 54493-54496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se10-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2000-P-0924] (formerly Docket No. FDA-2000-P-1533)

 
Cardiovascular Devices; Reclassification of Certain Percutaneous 
Transluminal Coronary Angioplasty (PTCA) Catheters

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the 
device type, standard percutaneous transluminal coronary angioplasty 
(PTCA) catheters, from class III (premarket approval) into class II 
(special controls). Cutting/scoring PTCA catheters remain in class III 
and continue to require premarket approval applications (PMAs). FDA is 
reclassifying these devices in accordance with the Federal Food, Drug, 
and Cosmetic Act (the act). Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of a guidance document 
entitled ``Guidance for Industry and FDA Staff: Class II Special 
Controls Guidance Document for Certain Percutaneous Transluminal 
Coronary Angioplasty (PTCA) Catheters'' that will serve as the special 
control for the reclassified device type.

DATES:  This final rule is effective October 8, 2010.

FOR FURTHER INFORMATION CONTACT:  Kathryn O'Callaghan, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-6349.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 105-115), 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, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f)) of the act (21 U.S.C. 
360c(f)) into class III without any FDA rulemaking process. Those 
devices remain in class III and require premarket approval, unless and 
until: (1) The device is reclassified into class I or II; (2) FDA 
issues an order classifying the device into class I or II in accordance 
with section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)); or (3) FDA 
issues an order finding the device to be substantially equivalent, 
under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate 
device that does not require premarket approval. The agency determines 
whether new devices are substantially equivalent to previously offered 
devices by means of premarket notification (510(k)) procedures in 
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the 
regulations (21 CFR part 807).
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a PMA until FDA issues a final regulation under section 
515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.
    Reclassification of postamendments devices is governed by section 
513(f)(3) of the act (21 U.S.C.360c(f)(3)). This section states that 
FDA may initiate the reclassification of a device classified into class 
III under section 513(f)(1) of the act, or that a manufacturer or 
importer of a device may petition the Secretary of Health and Human 
Services (the Secretary) for the issuance of an order classifying the 
device into class I or class II. FDA's regulations in 21 CFR 860.134 
set forth the procedures for the filing and review of a petition for 
reclassification of such class III devices. In order to change the 
classification of the device, it is necessary that the proposed new 
class have sufficient regulatory controls to provide reasonable 
assurance of the safety and effectiveness of the device for its 
intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may, for 
good cause shown, refer a petition to a device panel. If a petition is 
referred to a panel, the panel shall make a recommendation to the 
Secretary respecting approval or denial of the petition. Any such 
recommendation shall contain: (1) A summary of the reasons for the 
recommendation, (2) a summary of the data upon which the recommendation 
is based, and (3) an identification of the risks to health (if any) 
presented by the device with respect to which the petition was filed.

II. Regulatory History of the Device

    The PTCA catheter is a postamendments device classified into class 
III under section 513(f)(1) of the act. Therefore, the device cannot be 
placed in commercial distribution unless it is subject to an approved 
premarket approval application (PMA) under section 515 of the act (21 
U.S.C. 360e) or is reclassified.
    On September 21, 2000, FDA filed a petition submitted under section 
513(f)(3) of the act from COOK requesting reclassification of PTCA 
catheters from class III into class II. This reclassification petition 
did not include cutting or scoring PTCA catheters. In order to 
reclassify the PTCA catheter into class II, it is necessary that the 
proposed class have sufficient regulatory controls to provide 
reasonable assurance of safety and

[[Page 54494]]

effectiveness of the device for its intended use.
    The COOK petition requested reclassification of PTCA catheters from 
class III to class II when indicated for balloon dilatation of a 
hemodynamically significant coronary artery or bypass graft stenosis in 
patients evidencing coronary ischemia for the purpose of improving 
myocardial perfusion. Consistent with the act and the regulation, FDA 
referred the petition to the Panel for its recommendation on the 
requested changes in classification. FDA also asked the Circulatory 
System Devices Panel for its recommendation on the reclassification of 
PTCA catheters when used for treatment of acute myocardial infarction 
(MI), treatment of in-stent restenosis (ISR) and/or post-deployment 
stent expansion.

III. Device Description

    FDA identifies this generic type of device, the subject of this 
reclassification, as follows: Standard Percutaneous Transluminal 
Coronary Angioplasty (PTCA) Catheter. A PTCA catheter is a device that 
operates on the principle of hydraulic pressurization applied through 
an inflatable balloon attached to the distal end. A PTCA balloon 
catheter has a single or double lumen shaft. The catheter features a 
balloon of appropriate compliance for the clinical application, 
constructed from a polymer. The balloon is designed to uniformly expand 
to a specified diameter and length at a specific pressure as labeled, 
with well characterized rates of inflation and deflation and a defined 
burst pressure. The device generally features a type of radiographic 
marker to facilitate fluoroscopic visualization of the balloon during 
use. A PTCA catheter is intended for balloon dilatation of a 
hemodynamically significant coronary artery or bypass graft stenosis in 
patients evidencing coronary ischemia for the purpose of improving 
myocardial perfusion. A PTCA catheter may also be intended for the 
treatment of acute myocardial infarction; treatment of in-stent 
restenosis (ISR) and/or post-deployment stent expansion.
     FDA is also issuing the following identification for the devices 
that will remain in class III: A cutting/scoring PTCA catheter is a 
balloon-tipped catheter with cutting/scoring elements attached, which 
is used in those circumstances where a high pressure balloon resistant 
lesion is encountered. A cutting/scoring PTCA catheter is intended for 
the treatment of hemodynamically significant coronary artery stenosis 
for the purpose of improving myocardial perfusion. A cutting/scoring 
PTCA catheter may also be indicated for use in complex type C lesions 
or for the treatment of in-stent restenosis.

IV. Recommendation of the Panel

    At a public meeting on December 4, 2000, the Panel recommended 
(seven to one) that PTCA catheters be reclassified from class III to 
class II, when indicated for balloon dilatation of a hemodynamically 
significant coronary artery or bypass graft stenosis in patients 
evidencing coronary ischemia for the purpose of improving myocardial 
perfusion; or for treatment of acute myocardial infarction. The Panel 
did not recommend reclassification for PTCA catheters indicated for the 
treatment of in-stent restenosis and/or post-deployment stent 
expansion. The Panel recommended a guidance document, labeling, and 
postmarket surveillance as special controls. The Panel stated that the 
special controls will diminish some of the risks to health associated 
with certain PTCA catheters. The guidance document and labeling 
controls are intended to ensure the appropriate performance and use of 
the device by physicians. The Panel recommended postmarket surveillance 
as a special control to confirm that the other special controls being 
applied to these devices would be sufficient to ensure that there would 
not be an increase in adverse consequences to patients. In summary, the 
Panel believed that class II with special controls would provide 
reasonable assurance of the safety and effectiveness of the device.
    The Panel recommended that PTCA catheters for the treatment of in-
stent restenosis and/or post-deployment stent expansion not be included 
because of a lack of sufficient information about this use. Since the 
Panel meeting, however, additional data regarding this use have become 
available and have been reviewed by the agency.
    FDA considered the Panel's recommendations and tentatively agreed 
that PTCA catheters, other than cutting/scoring PTCA catheters, should 
be reclassified from class III into class II because special controls, 
in addition to general controls, would provide reasonable assurance of 
the safety and effectiveness of the device, and there is sufficient 
information to establish special controls to provide such assurance.
    Although the Panel included the possibility of requiring postmarket 
surveillance in their recommendation, FDA did not agree that specific 
postmarket surveillance such as device tracking or postapproval studies 
are needed for PTCA catheters. FDA believes that periodic assessment of 
adverse event reports through medical device reporting submitted to the 
agency is sufficient to address adverse effects caused by these devices 
and is the least burdensome way to gather this data for PTCA catheters. 
This practice is consistent with the manner in which these devices have 
been regulated as class III devices since the Panel meeting.
    Further, after a review of adverse event reports submitted to FDA's 
Manufacturer and User Facility Device Experience (MAUDE) Database, the 
agency believes that the types of risks associated with the use of PTCA 
catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion are similar enough to the risks associated 
with treatment of de novo lesions, such that the special controls 
discussed at the Panel meeting, with the addition of recommendations 
for specific nonclinical performance testing and the recommendation 
that in-stent restenosis patients be included in the clinical 
evaluation, when necessary, are adequate to control the risks to health 
for these devices.
    Accordingly, in the Federal Register of May 30, 2008 (73 FR 31123), 
FDA issued the Panel's recommendation for public comment. FDA did not 
receive any comments regarding the Panel's recommendation. Elsewhere in 
this issue of the Federal Register, comments received regarding the 
draft guidance document are addressed in the notice of availability 
announcing the special controls guidance document.

V. FDA's Conclusion

    After reviewing the data in the petition and presented at the Panel 
meeting, and after considering the Panel's recommendation and the 
comments on the notice of panel recommendation, FDA has determined that 
the device type, standard percutaneous transluminal coronary 
angioplasty (PTCA) catheters, can be reclassified from class III into 
class II.
    On August 19, 2010, FDA issued an order to the petitioner 
reclassifying the devices into class II (special controls). The order 
also identified the special control applicable to these devices as a 
guidance document entitled ``Class II Special Controls Guidance 
Document for Certain Percutaneous Transluminal Coronary Angioplasty 
(PTCA) Catheters.'' This class II special controls guidance document is 
now the special control for this device type.
    An alternative approach to the special controls guidance document 
may be used if such approach satisfies the applicable statute and 
regulations.

[[Page 54495]]

Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for this device type 
will need to address the issues covered in the special control 
guidance. However, the firm need only show that its device meets the 
recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness.
    Accordingly, as required by 21 CFR 860.134(b)(6) and (b)(7) of the 
regulations, FDA is announcing the reclassification of the standard 
percutaneous transluminal coronary angioplasty (PTCA) catheters, from 
class III into class II. In addition, FDA is issuing this final rule to 
codify the reclassification of the device by adding new Sec.  870.5100.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 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.

VII. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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 this device type, from class III 
to class II, will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act (21 U.S.C. 360e). Because reclassification will reduce 
regulatory costs with respect to this device, the agency certifies that 
the 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, before 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 $135 million, using the most current (2009) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    Based on an assessment of identified risks associated with the use 
of PTCA catheters, FDA finds the requirements associated with a 
premarket approval as a class III device do not provide an added public 
health benefit over those that would result from the requirements under 
a class II (with special controls). At the same time, PTCA catheter 
manufactures, as makers of class III devices, bear all the costs 
associated with a premarket approval, including the cost of submitting 
the premarket approval application (PMA) and payment of user fees. One 
previously published estimate (in 73 FR 7497) suggests that the costs 
to prepare a PMA could potentially reach $1,000,000, in addition to 
user fees of $217,787 in FY (fiscal year) 2010.
    In contrast, if reclassification becomes final, manufacturers of a 
PTCA catheter would pay a user fee of $4,007 for a 510(k) submission in 
FY 2010. While we do not have data to estimate the cost of preparing a 
510(k) submission, several different factors indicate that it would be 
less than the cost of a PMA. For example, a firm does not have to 
submit manufacturing information in its 510(k), which is required for a 
PMA application, thereby reducing the burden and documentation needed. 
Given the ability to evaluate nonclinical testing in a direct 
comparison to a predicate device in a 510(k), FDA anticipates that most 
new PTCA catheters will not require clinical data to support 510(k) 
clearance, whereas all PMAs have to include some form of clinical data 
to support PMA approval. This difference will result in a significant 
reduction in cost for the device manufacturer. A PMA also requires the 
sponsor to prepare a draft summary of safety and effectiveness 
document, which is not required for a 510(k).
    Based on the most recent 5 years, FDA estimates the following 
annual number of submissions received for PTCA catheters: 15 ``30-day 
Notice'' PMA supplements, 1 ``Normal 180-day Track'' PMA supplement, 
and 2 ``Real-Time Process'' PMA supplements. (Note: FDA has not 
received any ``Panel-Track'' supplements or original PMA submissions 
for this device in the past 5 years.) A ``30-day Notice'' is submitted 
for changes to a manufacturing process or method and assessed a user 
fee of $3,485 in FY 2010. When reclassification is final, these types 
of changes will not require clearance prior to the firm making the 
change in the majority of cases. Modifications to the method of 
manufacture of a device could require submission of a 510(k) if the 
changes could significantly affect the safety or effectiveness of the 
device, such as those that would currently require a ``Real-Time 
Process'' or ``Panel-Track'' PMA supplement. Based on FDA's experience, 
submission of a 510(k) for a modification to the method of 
manufacturing would be rare.
    In summary, this device reclassification would reduce the existing 
burden on manufacturers of PTCA catheters. The application of class II 
(with special controls) requirements would be consistent with the 
principle of applying the least degree of regulatory control necessary 
to provide reasonable assurance of safety and effectiveness.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires agencies to ``construe *** a Federal statute to preempt State 
law only where the statute contains an express preemption provision or 
there is some other clear evidence that the Congress intended 
preemption of State law, or where the exercise of State authority 
conflicts with the exercise of Federal authority under the Federal 
statute.'' Federal law includes an express preemption provision that 
preempts certain state requirements ``different from or in addition 
to'' certain Federal requirements applicable to devices. (See section 
512 of the act (21 U.S.C. 360k); Medtronic v. Lohr, 518 U.S. 470 
(1996); Riegel v. Medtronic, 128 S. Ct. 999 (2008)). The special 
controls established by this final rule create ``requirements'' for 
specific medical devices under 21 U.S.C. 360k, even though product 
sponsors have some flexibility in how they meet those requirements. 
Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

IX. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget

[[Page 54496]]

(OMB) under the Paperwork Reduction Act of 1995 is not required. 
Elsewhere in this issue of the Federal Register, FDA is issuing a 
notice announcing the guidance for the final rule. This guidance, 
``Guidance for Industry and FDA Staff: Class II Special Controls 
Guidance Document for Certain Percutaneous Transluminal Coronary 
Angioplasty (PTCA) Catheters,'' references previously approved 
collections of information found in FDA regulations.

List of Subjects in 21 CFR Part 870

    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 part 
870 is 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 870.5100 is added to subpart F to read as follows:


Sec.  870.5100  Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheter.

    (a) Standard PTCA Catheter--(1) Identification. A PTCA catheter is 
a device that operates on the principle of hydraulic pressurization 
applied through an inflatable balloon attached to the distal end. A 
PTCA balloon catheter has a single or double lumen shaft. The catheter 
features a balloon of appropriate compliance for the clinical 
application, constructed from a polymer. The balloon is designed to 
uniformly expand to a specified diameter and length at a specific 
pressure as labeled, with well characterized rates of inflation and 
deflation and a defined burst pressure. The device generally features a 
type of radiographic marker to facilitate fluoroscopic visualization of 
the balloon during use. A PTCA catheter is intended for balloon 
dilatation of a hemodynamically significant coronary artery or bypass 
graft stenosis in patients evidencing coronary ischemia for the purpose 
of improving myocardial perfusion. A PTCA catheter may also be intended 
for the treatment of acute myocardial infarction; treatment of in-stent 
restenosis (ISR) and/or post-deployment stent expansion.
    (2) Classification. Class II (special controls). The special 
control for this device is ``Class II Special Controls Guidance 
Document for Certain Percutaneous Transluminal Coronary Angioplasty 
(PTCA) Catheters.'' See Sec.  870.1(e) for the availability of this 
guidance document.
    (b) Cutting/scoring PTCA Catheter--(1) Identification. A cutting/
scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring 
elements attached, which is used in those circumstances where a high 
pressure balloon resistant lesion is encountered. A cutting/scoring 
PTCA catheter is intended for the treatment of hemodynamically 
significant coronary artery stenosis for the purpose of improving 
myocardial perfusion. A cutting/scoring PTCA catheter may also be 
indicated for use in complex type C lesions or for the treatment of in-
stent restenosis.
    (2) Classification. Class III (premarket approval). As of May 28, 
1976, an approval under section 515 of the act is required before this 
device may be commercially distributed. See Sec.  870.3.

    Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22304 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S

