[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Rules and Regulations]
[Pages 6893-6894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3173]



[[Page 6893]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. 93P-0277]


Medical Devices; Reclassification and Codification of 
Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for Peripheral 
Iridotomy

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has issued an order in the form of a letter to Intelligent Surgical 
Lasers, Inc. (ISL), (now doing business as Escalon Medical 
Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet 
(Nd:YAG) Laser for use in peripheral iridotomy from class III to class 
II (special controls). Accordingly, the order is now being codified in 
the Code of Federal Regulations (CFR) as described below.

DATES: This rule is effective March 13, 2000. The reclassification was 
effective August 13, 1999.

FOR FURTHER INFORMATION CONTACT: Morris Waxler, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2018.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Devices 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) 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 new section 513(f)(2) 
of the act, as amended by FDAMA; or (3) 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 offered 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 postamendments devices is governed by section 
513(f)(3) of the act, formerly 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 the Secretary of 
Health and Human Services (the Secretary) for issuance of an order 
classifying the device in class I or class II. FDA's regulations in 
Sec. 860.134 (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.
    FDAMA added paragraph (f)(2) in section 513 to the act, which also 
addresses classification of postamendments devices. New paragraph 
(f)(2) in section 513 of the act provides that, upon receipt of a ``not 
substantially equivalent'' determination, a 510(k) applicant may 
request FDA to classify a postamendments device into class I or class 
II. Within 60 days from the date of such a written request, FDA must 
classify the device by written order. If FDA classifies the device into 
class I or II, the applicant has then received clearance to market the 
device and it can be used as a predicate device for other 510(k)'s. It 
is expected that this process will be used for low risk devices. This 
process does not apply to devices that have been classified by 
regulation into class III--i.e., preamendments class III devices, or 
class III devices for which a PMA is appropriate.
    Under section 513(f)(3)(B)(i) of the act, formerly section 
513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, 
refer a petition to a classification 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.
    On July 27, 1993, FDA filed the reclassification petition submitted 
by ISL, requesting reclassification under section 513(f)(3) of the act, 
of the ophthalmic Nd:YAG laser (mode-locked or Q-switched) intended for 
peripheral iridotomy from class III to class II. This is a 
postamendments device that was automatically classified into class III.
    FDA consulted with the Ophthalmic Devices Panel (the Panel). During 
an open public meeting on October 28, 1993, the Panel recommended that 
FDA reclassify the Nd:YAG laser for peripheral iridotomy from class III 
to class II. The Panel considered clinical studies of Nd:YAG iridotomy 
that report few risks to health and those that are reported have been 
clearly identified. The incidence rates for iridotomy closure, vision 
loss due to progression of laser-induced lens or corneal damage, focal 
corneal opacities, mild iritis, and hyphema are either lower than those 
for argon laser surgery or conventional surgical iridotomy, or are 
self-limiting and not persistent. A few rare complications (malignant 
glaucoma, lens-induced endophthalmitis,

[[Page 6894]]

monocular glaucoma, lens rupture) have been reported. The risks of 
damage to the corneal endothelium, the lens, and the retina are slight. 
The Panel believes these risks can be kept minimal by ensuring proper 
device design of laser beam accuracy and precision.
    FDA considered the Panel's recommendations and tentatively agreed 
that the generic type of device, Nd:YAG laser for peripheral iridotomy, 
be reclassified from class III to class II. FDA recommended that the 
generic designation of the device be changed from Nd:YAG laser for 
posterior capsulotomy to ND:YAG laser for posterior capsulotomy and 
peripheral iridotomy.
    Subsequently, in the Federal Register of March 8, 1996 (61 FR 
9373), FDA issued the Panel's recommendation for public comment.
    After reviewing the data in the petition and presented before the 
Panel, and after considering the Panel's recommendation, FDA, based on 
its and the Panel's review, issued an order to the petitioner on August 
13, 1999, reclassifying the Nd:YAG laser for posterior capsulotomy, and 
substantially equivalent devices of this generic type, from class III 
to class II, with design parameters as the special controls. 
Additionally, FDA changed the generic designation of the device from 
Nd:YAG laser for posterior capsulotomy to Nd:YAG laser for posterior 
capsulotomy and peripheral iridotomy. FDA believes the risks mentioned 
above can be kept minimal by ensuring proper device design of the laser 
beam accuracy and precision, and through proper device labeling 
disclosures whereby the surgeon can control the risk of intraocular 
pressure rise through available, established medical treatments.
    Accordingly, as required by Sec. 860.134(b)(6) and (b)(7) of the 
regulations, FDA is announcing the reclassification of the generic 
Nd:YAG laser for posterior capsulotomy and peripheral iridotomy from 
class III into class II. In addition, FDA is issuing the notice to 
codify the reclassification of the device by revising 21 CFR 886.4392.

II. Environmental Impact

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

III. 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 
Enforcement 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 final 
rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the final rule 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 all manufacturers of the device 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 by lowering their costs. The Commissioner of Food 
and Drugs therefore certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this notice 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 or analysis under 
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

IV. 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.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

    1. The authority citation for 21 CFR part 886 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 886.4392 is revised to read as follows:


Sec. 886.4392  Nd:YAG laser for posterior capsulotomy and peripheral 
iridotomy.

    (a) Identification. The Nd:YAG laser for posterior capsulotomy and 
peripheral iridotomy consists of a mode-locked or Q-switched solid 
state Nd:YAG laser intended for disruption of the posterior capsule or 
the iris via optical breakdown. The Nd:YAG laser generates short pulse, 
low energy, high power, coherent optical radiation. When the laser 
output is combined with focusing optics, the high irradiance at the 
target causes tissue disruption via optical breakdown. A visible aiming 
system is utilized to target the invisible Nd:YAG laser radiation on or 
in close proximity to the target tissue.
    (b) Classification. Class II (special controls). Design Parameters: 
Device must emit a laser beam with the following parameters: wavelength 
= 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 
nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); 
repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.

    Dated: January 24, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-3173 Filed 2-10-00; 8:45 am]
BILLING CODE 4160-01-F