[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Rules and Regulations]
[Pages 48609-48612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. 98N-1134]
Gastroenterology and Urology Devices; Reclassification of the
Extracorporeal Shock Wave Lithotripter
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 from class III to class II the extracorporeal shock wave
lithotripter, when intended for use to fragment kidney and ureteral
calculi. FDA is taking this action on its own initiative in order to
assure that these devices are regulated according to the appropriate
degree of regulatory control needed to provide reasonable assurance of
their safety and effectiveness. Elsewhere in this issue of the Federal
Register, FDA is publishing a notice of availability of a guidance
document, which will serve as the special control for the reclassified
device.
DATES: This rule is effective September 8, 2000.
FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and
Radiological Health (HFZ-470), Food
[[Page 48610]]
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-594-2194.
SUPPLEMENTARY INFORMATION:
I. Background
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 (the 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, reflecting 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) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, under section 513(i) of the act,
to a predicate device that does not require premarket approval. The
agency determines whether new devices are substantially equivalent to
previously marketed devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR
part 807 of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (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 classified postamendments devices is governed
by section 513(f)(2) of the act. This section provides that FDA may
initiate the reclassification of a device classified into class III
under section 513(f)(1) of the act, or the manufacturer or importer of
a device may petition for the issuance of an order classifying the
device in 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.
Section 216 of FDAMA replaced the ``four of a kind'' rule in the
old section 520(h)(4) of the act (21 U.S.C. 360j(h)(4)) with a
provision that frees safety and effectiveness data in PMA's approved 6
or more years earlier for use by the agency in certain actions,
including device reclassifications. Under section 520(h)(4) of the act,
as amended by FDAMA, the agency has supplemented other sources of
information that support reclassification of the extracorporeal shock
wave lithotripter with data contained in PMA's approved 6 or more years
before the date of this rule. Although FDA has sufficient information
to support this reclassification without relying upon data available
under section 520(h)(4) of the act, the agency decided to use such data
in taking this action. In this instance, the data used would have been
available to the agency under the superseded four of a kind rule.
Under section 513(f)(2)(B)(i) of the act, the Secretary of Health
and Human Services (the Secretary), for good cause shown, may refer a
proposed reclassification to a device classification panel. The panel
shall make a recommendation to the Secretary respecting approval or
denial of the proposed reclassification. 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 proposed reclassification was initiated.
II. Response to Comments
FDA referred the issue of reclassification of the extracorporeal
shock wave lithotripter to the Gastroenterology and Urology Devices
Advisory Panel (the Panel) for review and recommendation. At a public
meeting on July 30, 1998, the Panel unanimously recommended that the
extracorporeal shock wave lithotripter indicated for the fragmentation
of kidney and ureteral calculi be reclassified from class III to class
II. The Panel believed that the special controls of consensus
standards, clinical performance testing, labeling restrictions, and
physician training restrictions would provide reasonable assurance of
the safety and effectiveness of the device. In the Federal Register of
February 8, 1999 (64 FR 5987), FDA published a summary of the Panel
recommendation and a proposed rule to reclassify the extracorporeal
shock wave lithotripter. FDA invited interested persons to submit
written comments by May 10, 1999. FDA received one comment that raised
several issues. The following is FDA's response to the issues raised by
the comment.
(Comment 1) The comment suggested that FDA should identify the
PMA's and PMA supplements that FDA relied upon in reclassifying the
device and make the summaries of safety and effectiveness for those
submissions available in the Dockets Management Branch.
FDA agrees. The PMA's that FDA relied upon are listed in section
VII ``References'' below and the summaries of safety and effectiveness
are available in the Dockets Management Branch, as stated there.
Section 520(h)(4)(b) of the act states that the summaries of safety and
effectiveness shall be available for use by FDA as the evidentiary
basis for a reclassification action. FDA notes, however, that section
520(h)(2) of the act provides that the summaries of safety and
effectiveness may not be used to establish the safety or effectiveness
of another device by any person other than the person who submitted the
information. In the case of certain supplements for which a summary of
safety and effectiveness was not prepared, FDA will make available a
redacted version of the supplement.
(Comment 2) The comment questions whether FDA believes that section
520(h)(4) of the act allows for the use of information from PMA
supplements as well as original PMA's.
Yes. Section 520(h)(4) of the act authorizes FDA to use data
contained in applications for premarket approval submitted under
section 515(c) of the act. The 6-year provision, then, applies equally
to initial PMA submissions and PMA supplements, which are applications
for premarket approval of a changed device and are submitted under
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section 515(c) of the act, the general PMA authority.
(Comment 3) The comment also said that persons submitting a
premarket notification (510(k)) other than holders of approved PMA's
and PMA supplements should only be able to use as predicate devices
model numbers or modified versions of extracorporeal shock wave
lithotripters legally marketed under a 510(k), PMA, or PMA supplement
no sooner than 6 years before the applicant's 510(k) submission for a
new or modified device. Holders of an approved PMA or PMA supplement
should be the only applicants permitted to cite as a predicate the
device for which they have an approved application fewer than 6 years
old.
FDA disagrees with this comment. Section 513(i) of the act provides
that substantial equivalence may be determined based upon comparison
with any legally marketed device. The intent of section 520(h)(4) of
the act is to provide an additional source of information upon which
certain actions can be based. Section 520(h)(4) of the act does not
place any limitations on the type of device that may be used as a
predicate device.
(Comment 4) The comment said that the indications for use in the
proposed rule are inconsistent with those in the approved PMA's and PMA
supplements to date. The comment also said that the labeling
restrictions in the rule do not address indications for use and
questioned how manufacturers may switch to the broad intended use in
the rule.
FDA disagrees. The intended use in the rule (i.e., ``fragmentation
of urinary calculi within the kidney and ureter'') is consistent with
prior approvals. Although some devices were restricted in their
intended use to certain stone locations or size ranges based on the
results or circumstances of their specific clinical studies, others had
adequate data supporting the more general intended use. Therefore, the
broad intended use in the rule incorporates both of the individual
intended uses that have been approved to date. This approach was based
on findings in the literature that the differences in intended use of
approved lithotripters were not primarily related to differences in
technological characteristics. Because FDA is reclassifying a broad
intended use, FDA believes that it is appropriate to list the various
stone characteristics known to be associated with reduced effectiveness
as precautions in the labeling. Manufacturers who have cleared devices
with the limited intended uses can seek clearance to market their
devices for the broad intended use by submitting a 510(k) comparing the
device to a predicate that has the broad intended use.
(Comment 5) The comment noted that the guidance suggests that a
confirmatory clinical study should enroll at least 20 patients at 2
sites. The comment questioned whether this means 20 patients at each
site or 20 patients total at both sites. The comment further said that,
in either case, the number is insufficient. The comment suggested that
FDA should require 30 patients each at 3 sites and the study should
include an assessment of treatment success and adverse effects
immediately post-procedure and at 2 weeks and 1 month thereafter.
The guidance has been revised to clarify that clinical testing of
devices that are similar in technological characteristics to legally
marketed devices should include at least 20 patients total at 2 sites.
FDA disagrees with the comment that there is a need to assess device
safety and effectiveness outcomes in a statistically justified sample
size. FDA believes that clinical testing in these circumstances is
intended only to confirm device functionality and the adequacy of the
proposed labeling rather than to assess device safety and
effectiveness. FDA believes that the characterization testing described
in the guidance is sufficient to demonstrate safety and effectiveness
with respect to clinical outcomes for devices with similar
technological characteristics. As noted in the proposed rule and
guidance document, however, 510(k)'s for devices that have different
technological characteristics from legally marketed predicates will
likely require larger, statistically justified, clinical studies to
investigate the effect of the new technological characteristics on
safety and effectiveness outcomes. For these cases, the study design
should be tailored to the specifics of the new characteristics;
therefore, we do not believe that a standard detailed study design
should be spelled out.
(Comment 6) The comment suggested that the restricted device legend
for the device should be revised to read: ``CAUTION: Federal law
restricts this device to sale, distribution, and use only upon the
lawful order of a physician trained and/or experienced in the use of
this device as outlined in the required training program.'' The comment
also suggested that this statement should be included in the regulation
and not just in the guidance.
FDA agrees in part with this comment. FDA has added the words
``distribution or use'' after ``sale'' so as to track the language in
section 520(e) of the act. FDA does not believe that it would not be
correct to replace the phrase ``appropriate training program'' with
``required training program'' as suggested by the comment, because FDA
does not regulate all aspects of the training program. Also, FDA does
not believe that it is necessary to add the language to the regulation,
because the requirement is already covered by 21 CFR 801.109(b)(1). FDA
has decided not to include the labeling in an appendix to Sec. 876.5990
(21 CFR 876.5990). Instead, the labeling will be included in the
guidance document only. FDA also slightly revised the identification
section in Sec. 876.5990(a) by removing the words ``through a water-
filled rubber cushion or by direct contact of the patient's skin with
the water'' and replacing them with ``using an appropriate acoustic
interface.''
III. Final Rule
Therefore, FDA is finalizing the rule reclassifying the
extracorporeal shock wave lithotripter into class II with the FDA
guidance document entitled ``Guidance for the Content of Premarket
Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters
Indicated for the Fragmentation of Kidney and Ureteral Calculi,'' as
the special control. Elsewhere in this issue of the Federal Register,
FDA is publishing a notice of availability of the guidance document.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(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.
V. 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) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121), 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 reclassification action is
consistent with the regulatory
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philosophy and principles identified in the Executive Order. In
addition, the reclassification action is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review 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 the
device from class III to class II will relieve manufacturers of the
cost of complying with the premarket approval requirements in section
515 of the act. Because reclassification will reduce regulatory costs
with respect to this device, it will impose no significant economic
impact on any small entities, and it may permit small potential
competitors to enter the marketplace at lower costs. The agency
therefore certifies that this reclassification action will not have a
significant economic impact on a substantial number of small entities.
In addition, this reclassification action will not impose costs of $100
million or more on either the private sector or state, local, and
tribal governments in the aggregate, and therefore a summary statement
of analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no information that is
subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995. The special controls do not require
the respondent to submit additional information to the public.
Therefore, no burden is placed on the public.
VII. References
The following references have been placed on display in the Dockets
Management Branch, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday.
1. P840008/S24, MFL 5000 Lithotripter, Dornier Medical Systems,
Inc., July 3, 1991.
2. P840008/S26, MFL 9000 Lithotripter, Dornier Medical Systems,
Inc., August 12, 1991.
3. Summary of Safety and Effectiveness, P890013, Piezolith
Lithotripter, Model 2300, Richard Wolf Medical Instruments Corp.,
September 9, 1991.
4. Summary of Safety and Effectiveness, P880042, LT.01
Lithotripter, EDAP International Corp., December 12, 1991.
5. Summary of Safety and Effectiveness, TP890006, Therasonic
Lithotripsy Treatment System, Diasonics, Inc., December 20, 1991.
List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
1. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Section 876.5990 is added to subpart F to read as follows:
Sec. 876.5990 Extracorporeal shock wave lithotripter.
(a) Identification. An extracorporeal shock wave lithotripter is a
device that focuses ultrasonic shock waves into the body to
noninvasively fragment urinary calculi within the kidney or ureter. The
primary components of the device are a shock wave generator, high
voltage generator, control console, imaging/localization system, and
patient table. Prior to treatment, the urinary stone is targeted using
either an integral or stand-alone localization/imaging system. Shock
waves are typically generated using electrostatic spark discharge
(spark gap), electromagnetically repelled membranes, or piezoelectric
crystal arrays, and focused onto the stone with either a specially
designed reflector, dish, or acoustic lens. The shock waves are created
under water within the shock wave generator, and are transferred to the
patient's body using an appropriate acoustic interface. After the stone
has been fragmented by the focused shock waves, the fragments pass out
of the body with the patient's urine.
(b) Classification. Class II (special controls) (FDA guidance
document: ``Guidance for the Content of Premarket Notifications
(510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for
the Fragmentation of Kidney and Ureteral Calculi.'')
Dated: July 12, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-20089 Filed 8-8-00; 8:45 am]
BILLING CODE 4160-01-F