[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