[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Rules and Regulations]
[Pages 30985-30988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. 95N-0400]


Ophthalmic Devices: Reclassification of Rigid Gas Permeable 
Contact Lens Solution; Soft (Hydrophilic) Contact Lens Solution; and 
Contact Lens Heat Disinfecting Unit

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 
reclassifying from class III (premarket approval) to class II (special 
controls) rigid gas permeable contact lens solution, soft (hydrophilic) 
contact lens solution, and the contact lens heat disinfection unit. 
Collectively, these devices are referred to as transitional contact 
lens care products, which include saline solutions; in-eye lubricating/
rewetting drops; disinfecting and conditioning products; contact lens 
cleaners; and heat disinfecting units. This reclassification is in 
accordance with provisions in the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA). 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a guidance describing the evidence that may demonstrate 
the substantial equivalence of new contact lens care products to 
legally marketed predicate lens care products.

EFFECTIVE DATE: July 7, 1997.

FOR FURTHER INFORMATION CONTACT: James F. Saviola, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1744.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 321 et. seq.), as amended by the 1976 amendments 
(Pub. L. 94-295) and the SMDA (Pub. L. 101-629), established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) establishes three 
classes of devices, depending on the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness: Class 
I, general controls; class II, special controls; and class III, 
premarket approval.
    The 1976 amendments broadened the definition of ``device'' in 
section 201(h) of the act (21 U.S.C. 321(h)) to include certain 
articles that were once regulated as drugs. Under the 1976 amendments, 
Congress classified into class III all transitional devices (i.e., 
those devices previously regulated as new drugs). The legislative 
history of the SMDA reflects congressional concern that many 
transitional devices were being overregulated in class III (H. Rept. 
808, 101st Cong., 2d sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d 
sess. 26-27 (1990)). Congress amended section 520(l) of the act (21 
U.S.C. 360j(l)) to direct FDA to collect certain safety and 
effectiveness information from the manufacturers of transitional 
devices still remaining in class III to determine whether the devices 
should be reclassified into class II (special controls) or class I 
(general controls). Accordingly, in the Federal Register of November 
14, 1991 (56 FR 57960), FDA issued an order under section 520(l)(5)(A) 
of the act, requiring manufacturers of transitional devices, including 
rigid gas permeable contact lens solution (Sec. 886.5918 (21 CFR 
886.5918)); soft (hydrophilic) contact lens solution (Sec. 886.5928 (21 
CFR 886.5928)); and the contact lens heat disinfection unit 
(Sec. 886.5933 (21 CFR 886.5933)), to submit to FDA a summary of, and a 
citation to, any information known or otherwise available to them 
respecting the devices, including adverse safety or effectiveness 
information which had not been submitted under section 519 of the act 
(21 U.S.C. 360i). Manufacturers were to submit the summaries and 
citations to FDA by January 13, 1992. However, because of 
misunderstandings and uncertainties regarding the information required 
by the order, and whether the order applied to certain manufacturers' 
devices, many transitional class III device manufacturers failed to 
comply with the reporting requirement by January 13, 1992. 
Consequently, in the Federal Register of March 10, 1992 (57 FR 8462), 
FDA extended the reporting period to March 31, 1992.
    Section 520(l)(5)(B) of the act, provides that, after the issuance 
of an order requiring manufacturers to submit a summary of, and 
citation to, any information known or otherwise available respecting 
the devices, but before December 1, 1992, FDA was to publish 
regulations either leaving transitional class III devices in class III 
or reclassifying them into class I or II. Subsequently, as permitted by 
section 520(l)(5)(C) of the act, in the Federal

[[Page 30986]]

Register of November 30, 1992 (57 FR 56586), the agency published a 
notice extending the period for issuing such regulations until December 
1, 1993. Due to limited resources, FDA was unable to publish the 
regulations before the December 1, 1993, deadline.
    In the Federal Register of April 1, 1996 (61 FR 14277), FDA 
published a proposed rule to reclassify from class III (premarket 
approval) to class II (special controls) rigid gas permeable contact 
lens solution, soft (hydrophilic) contact lens solution, and the 
contact lens heat disinfecting unit. The proposed rule contained 
reasons for the proposed reclassification, identified the risks to 
health presented by the device, and included a summary of the data upon 
which the proposed reclassification was based. Written comments were 
requested by June 17, 1996.

II. Summary and Analysis of Comments and FDA's Responses

    Only one person from the public commented on the proposal. This 
comment stated that: (1) The proposed rule did not provide a rational 
basis for reclassification because it did not summarize, or provide a 
bibliography of, supporting safety and effectiveness information so 
that interested persons could challenge the proposal; (2) FDA was 
basing its reclassification on protected information in approved 
premarket approval applications (PMA's) and on information submitted in 
response to the order issued under section 520(l)(5)(A) of the act; and 
(3) the special control document only addresses safety issues and does 
not encompass device effectiveness.
    FDA disagrees that the proposed rule did not provide a rational 
basis for reclassification of these devices. Section 520(l)(5)(B) 
states: ``In determining whether to revise the classification of a 
device or to require a device to remain in class III, the Secretary 
shall apply the criteria set forth in section 513(a).'' In accordance 
with those criteria, FDA has determined that special controls, in the 
form of the 510(k) guidance document would provide reasonable assurance 
of the safety and effectiveness of these devices. FDA made this 
determination based on its identification of the risks to health 
presented by these devices and on its review of preclinical and 
clinical data and adverse experience reports. FDA did not use 
information made available under section 520(h)(1) or (h)(2) of the act 
to ``establish the safety or effectiveness of another device'', as 
alleged by the comment.
    The SMDA mandates that FDA review the classification of 
transitional devices and reclassify them into class I or class II 
unless FDA can justify requiring them to remain in class III. FDA has 
determined that premarket approval is not necessary for these devices 
because a special control entitled, ``Guidance for Industry; Premarket 
Notification (510(k)) Guidance Document for Contact Lens Care 
Products,'' is sufficient to provide reasonable assurance of the safety 
and effectiveness of the devices. Consequently, FDA cannot justify 
requiring these devices to remain in class III.
    FDA believes that it was Congress' intent that, whenever possible, 
FDA use the historical information and expertise it has obtained in 
reviewing scientific data to designate special controls that can be 
used as a basis for reclassifying devices. FDA has had over 25 years of 
experience in reviewing and evaluating preclinical and clinical data 
contained in more than 100 PMA's; hundreds of PMA annual reports that 
include identification of adverse reactions reported for the device; 
the medical device reporting (MDR) data base within FDA; information 
submitted under section 520(l)(5)(A) of the act; and volumes of 
scientific literature for contact lens care products. FDA did not 
publish a bibliography of literature articles supporting safety and 
effectiveness information because of the voluminous number of 
literature articles published for all of the devices included in this 
reclassification. FDA is not using data from PMA's to support 
reclassification of these devices and will not disclose protected 
information in approved PMA's.
    FDA disagrees that the guidance document does not address 
effectiveness issues. Some examples of recommended testing to address 
effectiveness included in the document are cleaning effectiveness, 
compatibility testing, and clinical testing to confirm results of 
preclinical testing.
    The same comment suggested that the agency clarify the 
classification status of contact lens cases.
    At the January 26, 1995, meeting of the Ophthalmic Devices Panel, 
members unanimously recommended that contact lens cases be classified 
in class II. In the near future, FDA intends to publish a proposal in 
the Federal Register classifying contact lens cases in class II and 
including them under Sec. 886.5928.
    In accordance with sections 520(l)(5)(B) and 513(a) of the act, FDA 
is reclassifying rigid gas permeable contact lens solution 
(Sec. 886.5918); soft (hydrophilic) contact lens solution 
(Sec. 886.5928); and the contact lens heat disinfection unit 
(Sec. 886.5933) from class III (premarket approval) to class II 
(special controls). FDA does not believe that these devices can be 
classified into class I because general controls by themselves are 
insufficient to provide reasonable assurance of the safety and 
effectiveness of the devices. However, FDA does believe that these 
devices can be classified into class II because sufficient information 
exists to establish special controls to provide reasonable assurance of 
their safety and effectiveness. The revised guidance document entitled, 
``Guidance for Industry; Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products,'' the availability of which is 
being announced elsewhere in this issue of the Federal Register, is the 
special control that FDA believes is necessary to provide such 
assurance.

III. Transitional Phase for Pending PMA's for Contact Lens Care 
Products

    Below, FDA discusses how it will deal with the pending original and 
supplemental PMA's involving contact lens care products currently filed 
with the agency. As of today's date, all pending PMA applications will 
need to be examined to identify: (1) Those that are no longer subject 
to PMA review and can be converted to 510(k)'s or withdrawn and 
resubmitted to FDA by the sponsor to be evaluated through the 510(k) 
process; and (2) those that can be withdrawn by the sponsor and are not 
required to be resubmitted and evaluated as a 510(k) prior to 
implementing the request. FDA will make all final decisions on 
converted PMA's based on 510(k) regulatory requirements as elaborated 
in the document entitled, ``Guidance for Industry; Premarket 
Notification (510(k)) Guidance Document for Contact Lens Care 
Products.''
    To ensure expeditious conversions, sponsors should review their 
pending PMA's and advise the agency as to what administrative action 
the sponsor believes needs to be taken regarding their pending 
applications affected by the reclassification. As of the effective date 
of this final rule, FDA will suspend the review of each pending 
original and supplemental PMA affected in whole or in part by this 
reclassification until the respective sponsor amends its application, 
setting forth the status of the device and the administrative action 
requested.
    To convert a pending original or supplemental PMA to a 510(k), the 
sponsor should submit an amendment to the applicable PMA or 
supplemental PMA requesting that it be converted in total to a 510(k). 
The amendment should: (1) Request that the application be converted in 
total to a 510(k), (2) include a claim of substantial

[[Page 30987]]

equivalence to a previously approved contact lens care product (a 
product included in this reclassification), and (3) provide all 510(k) 
content requirements not submitted in the pending PMA or supplemental 
PMA, thus making the application as complete as possible when converted 
to a 510(k). Because preclinical and clinical data formerly required in 
a PMA may be necessary to support a substantial equivalence 
determination, a sponsor may provide references to applicable 
preclinical and clinical data contained in the sponsor's approved 
PMA('s) rather than duplicating the same data in a 510(k). When 
referencing data previously reviewed by the agency, the sponsor should 
clearly identify the relevant PMA number(s) and section(s) of the PMA 
or supplemental PMA. Pending original or supplemental PMA's converted 
to 510(k)'s will retain their position in the review queue (if they are 
complete), and the review process will continue without further delay.
    To withdraw and resubmit a pending original or supplemental PMA, 
the sponsor should first submit an amendment to the applicable PMA 
requesting that it be withdrawn. The sponsor should then determine 
whether the request should be resubmitted and evaluated through the 
510(k) process or be implemented without the need for submission of a 
510(k). All original PMA's should be resubmitted as 510(k)'s. However, 
not all supplemental PMA requests require the submission of a 510(k). 
For example, unlike PMA's, under the 510(k) regulations, sponsors are 
not required to submit a 510(k) for an additional manufacturing site 
for a cleared device. To determine whether a 510(k) is required, the 
sponsor should consult the 510(k) procedures (21 CFR part 807) and the 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.'' Any required 510(k) 
submission should follow the content and format requirements for 
510(k)'s. However, sponsors may provide references to preclinical and 
clinical data in the pending PMA or in approved PMA's rather than 
duplicating the data in a 510(k). When referencing data previously 
reviewed by the agency, the sponsor should clearly identify the 
relevant PMA number(s) and sections of the PMA or supplemental PMA. The 
sponsor should include in the 510(k) a claim of substantial equivalence 
to an applicable legally marketed contact lens care product (a product 
included in this reclassification) and a summary of safety and 
effectiveness information or a statement that the sponsor will make the 
safety and effectiveness information available to interested persons 
upon request.
    To withdraw a pending supplemental PMA that contains a request that 
can be implemented without the need for submission of a 510(k), the 
sponsor should submit an amendment to the applicable supplemental PMA 
requesting that it be withdrawn.
    In addition, sponsors should determine if there is information in 
the pending PMA that would not be needed when resubmitted as a 510(k) 
application. In making this determination, FDA cautions sponsors to 
review the regulations pertaining to releasability of information in 
PMA's and 510(k) submissions since different disclosure rules apply to 
PMA's and 510(k) submissions. For this reason, a manufacturer may 
choose not to have a pending PMA converted to a 510(k) submission, but 
instead choose to withdraw the pending application, purge it of 
unnecessary information that the sponsor might not want released, and 
resubmit the relevant data in a new 510(k) submission.
    If a sponsor fails to submit an amendment as outlined above within 
180 days of the effective date of reclassification, FDA will consider 
the pending PMA or PMA supplement to be voluntarily withdrawn. In such 
cases, the agency will notify the sponsor by letter of the withdrawal. 
All amendments to pending PMA's shall include the PMA or PMA supplement 
number and shall be addressed to the PMA Document Mail Center (HFZ-
401), Center for Devices and Radiological Health, Office of Device 
Evaluation, 9200 Corporate Blvd., Rockville, MD 20850. Additional 
questions regarding administrative procedures resulting from this 
reclassification should be directed to the PMA Staff (Kathy Poneleit, 
301-594-2186), or to the Division of Ophthalmic Devices, Vitreoretinal 
and Extraocular Devices Branch (James F. Saviola, or Muriel Gelles, 
301-594-1744.)

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) 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). 
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. Because this final rule would reduce the regulatory 
burdens for all manufacturers of contact lens care products covered by 
this rule, the Commissioner of Food and Drugs certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.
    Accordingly, FDA is amending the regulations in Secs. 886.5918, 
886.5928, and 886.5933 as set forth below.

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: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. Section 886.5918 is revised to read as follows:

Sec. 886.5918  Rigid gas permeable contact lens care products.

    (a) Identification. A rigid gas permeable contact lens care product 
is a device intended for use in the cleaning, conditioning, rinsing, 
lubricating/rewetting, or storing of a rigid gas permeable contact 
lens. This includes all solutions and tablets used together with rigid 
gas permeable contact lenses.
    (b) Classification. Class II (Special Controls) Guidance Document:

[[Page 30988]]

 ``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''
    3. Section 886.5928 is revised to read as follows:

Sec. 886.5928  Soft (hydrophilic) contact lens care products.

    (a) Identification. A soft (hydrophilic) contact lens care product 
is a device intended for use in the cleaning, rinsing, disinfecting, 
lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. 
This includes all solutions and tablets used together with soft 
(hydrophilic) contact lenses and heat disinfecting units intended to 
disinfect a soft (hydrophilic) contact lens by means of heat.
    (b) Classification. Class II (Special Controls) Guidance Document: 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''


Sec. 886.5933  [Removed and Reserved]

    4. Section 886.5933 Contact lens heat disinfection unit is removed 
and reserved.

    Dated: May 28, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-14751 Filed 6-5-97; 8:45 am]
BILLING CODE 4160-01-F