[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Proposed Rules]
[Pages 14277-14280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7784]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. 95N-0400]
RIN 0910-AA09


Medical Devices; Reclassification and Codification 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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing 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 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 
response to 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). FDA is 
also amending the regulations for transitional contact lens care 
products to more accurately reflect the intent of the original 
regulation. Under the SMDA, FDA is implementing a special control that 
the agency has determined is necessary to provide reasonable assurance 
of the safety and effectiveness of the proposed reclassified contact 
lens care products. That special control is the availability of 
guidance for premarket notification submissions for these products. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of a draft guidance describing the evidence that 
demonstrates the substantial equivalence of new contact lens care 
products to contact lens care products already marketed.

DATES: Written comments by June 17, 1996. The agency proposes that any 
final rule that may issue based on this proposal become effective 30 
days after date of publication of the final rule in the Federal 
Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: David M. Whipple, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2205.

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), establishes 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 all transitional devices (i.e., those devices 
previously regulated as new drugs), including: Rigid gas permeable 
contact lens solutions; soft (hydrophilic) contact lens solutions; and 
contact lens heat disinfecting units, into class III (premarket 
approval). The legislative history of the SMDA reflects congressional 
concern that many transitional devices were being over regulated 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 and review the classification of those still 
remaining in class III to determine if the device could be reclassified 
into class II (special controls) or class I (general controls).

[[Page 14278]]
Thus, in the Federal Register of November 14, 1991 (56 FR 57960), FDA, 
pursuant to section 520(l)(5)(A) of the act, issued an order 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 
has 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. Thus, 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 (21 U.S.C. 360j(l)(5)(B)), stated 
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 the transitional class III 
devices in class III or reclassifying them into class I or class II. 
Subsequently, as permitted by section 520(l)(5)(C) of the act (21 
U.S.C. 360j(l)(5)(C)), in the Federal 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 regulations before the December 1, 
1993, deadline. Nevertheless, in accordance with sections 520(l)(5)(B) 
and 513(a) of the act, FDA is now proposing to reclassify 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 draft guidance entitled ``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.

II. Description of the Devices Proposed for Reclassification and 
Explanation of Proposed Modifications

    The proposed reclassification and modifications are described 
below:

A. Section 886.5918 Rigid Gas Permeable Contact Lens Care Products

    FDA is proposing to change the classification title ``Rigid gas 
permeable contact lens solution'' to ``Rigid gas permeable contact lens 
care products'' to more accurately reflect the types of products 
classified under this regulation. Changing the word ``solution'' to 
``products'' allows the agency to regulate other rigid gas permeable 
care products under this section.
    FDA is also proposing to change the phrase ``to clean, disinfect, 
wet, or store a rigid gas permeable contact lens'' to ``for use in the 
cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a 
rigid gas permeable contact lens'' to more accurately describe the 
intended use of contact lens care products rather than limit the 
description to solutions only. FDA does not consider this proposed 
modification a change in intended use for the following reasons:
    1. Adding the word ``rinsing'' is proposed to accurately describe 
products (i.e., salines) approved under this classification for rinsing 
rigid gas permeable contact lenses;
    2. Replacing the word ``wet'' with the phrase ``lubricating/
rewetting'' is proposed to more accurately describe the intended use 
(i.e., in-eye) of lubricating and rewetting drops that have been 
approved for use with rigid gas permeable contact lenses; and
    3. Replacing the word ``disinfect'' with the word ``conditioning'' 
is proposed because rigid gas permeable ``disinfecting'' solutions are 
more accurately called conditioning solutions. Not only are these 
solutions used to disinfect rigid gas permeable lenses, but they are 
also used to condition the surface of the lenses prior to insertion. 
The combination of these two intended uses, disinfecting and 
conditioning, is commonly referred to as a conditioning solution when 
indicated for use with rigid gas permeable lenses.
    Finally, FDA is proposing to add ``This includes all solutions and 
tablets used together with rigid gas permeable contact lenses'' to 
further clarify that tablets (i.e., enzyme tablets used for periodic 
cleaners) are also included in this proposed reclassification. Tablets 
were not included in the original regulation because, at the time of 
its issuance, these care products were not approved for use with rigid 
gas permeable lenses. However, this is no longer the case.

B. Section 886.5928 Soft (Hydrophilic) Contact Lens Care Products

    FDA is proposing to change the classification title ``Soft 
(hydrophilic) contact lens solution'' to ``Soft (hydrophilic) contact 
lens care products'' to more accurately reflect the intent of the 
original regulation. Changing the word ``solution'' to ``products'' 
allows the agency to regulate other soft (hydrophilic) contact lens 
care products (i.e., lens cases) under this section. It also allows FDA 
to include heat disinfecting units under this section.
    FDA is also proposing to change the phrase ``to clean, disinfect, 
wet, or store a soft (hydrophilic) contact lens'' to ``for use in the 
cleaning, disinfecting, rinsing, lubricating/rewetting, or storing of a 
soft (hydrophilic) contact lens'' to more accurately describe the 
intended use of contact lens care products rather than limit the 
description to solutions only. FDA does not consider this modification 
a change in intended uses for the following reasons:
    1. Adding the word ``rinsing'' is proposed because rinsing 
solutions have always been a part of the care regimen for soft 
(hydrophilic) contact lenses. FDA believes the word was inadvertently 
omitted from the original regulation; and
    2. Replacing the word ``wet'' with the phrase ``lubricating/
rewetting'' is proposed to more accurately describe the intended use 
(i.e., in-eye) of lubricating and rewetting drops that have been 
approved for use with soft (hydrophilic) contact lenses.
    Finally, FDA is proposing to add ``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'' to further clarify that tablets (i.e., salt 
tablets used to make saline solutions, enzyme tablets used for periodic 
cleaners, and neutralizing tablets used to neutralize hydrogen peroxide 
disinfecting solution in soft

[[Page 14279]]
(hydrophilic) lenses) are also included in the proposed 
reclassification. This sentence also clarifies the fact that the heat 
disinfecting unit classification has been combined with the 
classification for soft (hydrophilic) contact lens care products.

C. Section 886.5933 Contact Lens Heat Disinfecting Unit

    Finally, because FDA is proposing to classify contact lens heat 
disinfecting units in the same classification as other soft contact 
lens products, FDA is proposing to remove in its entirety the contact 
lens heat disinfecting unit classification (Sec. 886.5933), combine 
this classification with soft (hydrophilic) contact lens care products 
(Sec. 886.5928), and reclassify from class III (premarket approval) to 
class II (special controls) this proposed combined device.

III. Summary of Reasons for the Proposed Reclassification

    The following are reasons in support of FDA's proposal to 
reclassify from class III to class II rigid gas permeable contact lens 
care products and soft (hydrophilic) contact lens care products, which 
include contact lens heat disinfecting units:
    1. General controls by themselves are insufficient to provide 
reasonable assurance of the safety and effectiveness of the devices.
    2. There is sufficient information to establish special controls to 
provide reasonable assurance of the safety and effectiveness of the 
devices for their intended uses.
    3. The special control, which is draft guidance entitled 
``Premarket Notification (510(k)) Guidance Document for Contact Lens 
Care Products,'' describes the testing and information applicable to 
premarket notifications for the devices.
    4. There is sufficient information to demonstrate that the devices 
are not potentially hazardous to the life, health, or well-being of the 
user. FDA has identified no new risks to health associated with the use 
of the devices, has determined that the identified potential risks to 
health can be addressed by using the special control (guidance), and 
that the probable benefits to health of the devices outweigh any 
probable risks to health.
    FDA believes that current and future manufacturers of the devices 
can use the special controls draft guidance and that the safety and 
effectiveness of devices made by new manufacturers can be assured 
through the premarket notification procedures under section 510(k) of 
the act (21 U.S.C. 360(k)) as described in the special control draft 
guidance. Consequently, FDA believes that premarket approval is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of these devices.

IV. Risks to Health

    The risks associated with the devices proposed for reclassification 
have been identified through over 25 years of FDA experience in the 
review and evaluation of the following publicly available information: 
(1) Preclinical and clinical data submitted in premarket approval 
applications (PMA's); (2) PMA annual reports and Mandatory Device 
Reporting (MDR) for contact lens devices; (3) scientific literature 
relating to contact lens devices; and (4) information submitted under 
section 520(l)(5)(A) of the act. A summary of the risks to health 
presented by each of the devices is described below:
    1. Risks associated with use of rigid gas permeable and soft 
(hydrophilic) contact lens care products, other than contact lens heat 
disinfection units include:
    Eye infection, irritation, burning and stinging, discomfort or 
pain, redness, excessive tearing, sensitivity to light, unusual 
secretions, dryness or vision changes; allergic, toxic or sensitivity 
reactions; damaged lenses which are caused by contaminated solutions; 
use of contact lens care products that fail to adequately perform their 
intended functions; sensitizing or toxic ingredients used in contact 
lens care product formulations; and inadequate labeling (e.g., 
warnings, precautions, and directions for use) for the safe and 
effective use of the device.
    2. Risks associated with use of contact lens heat disinfection 
units include:
    Fire, burns, or electrical shock; eye infections; damage to lenses 
caused by failure of the unit to adequately perform its intended 
function; and inadequate labeling (e.g., warnings, precautions, 
directions for use) for safe and effective use of the device.
    Based upon FDA's experience in evaluating publicly available data 
and information contained in PMA's, PMA annual reports, MDR, and 
scientific literature, FDA has concluded that the risks to health 
associated with the use of the devices could be controlled by special 
controls. On the basis of its review, FDA now believes that use of the 
rigid gas permeable contact lens care products and soft (hydrophilic) 
contact lens care products, including contact lens heat disinfection 
units, do not present a potential unreasonable risk to the public 
health, and that special controls in the form of guidance to 510(k) 
submitters would provide reasonable assurance of the safety and 
effectiveness of the device.

V. Summary of Data Upon Which the Proposed Reclassification is 
Based (1)

     FDA based its proposed reclassification of contact lens care 
products on over 25 years of experience in the review and evaluation of 
publicly available preclinical and clinical data contained in: More 
than 100 PMA's; hundreds of PMA annual reports that included 
identification of adverse reactions reported for the device; the MDR 
data base within FDA; information submitted under section 520(l)(5)(A) 
of the act; and scientific literature for contact lens care products. 
From this experience in evaluating this information, FDA has identified 
the risks to health associated with these devices as listed in section 
IV. of this document and has developed product-specific ``special 
controls'' to address these risks for purposes of this reclassification 
proposal. On the basis of the review, FDA believes that use of the 
rigid gas permeable contact lens care products and soft (hydrophilic) 
contact lens care products, including heat disinfection units, does not 
present an unreasonable risk to the public health, and that the special 
controls will provide reasonable assurance of the safety and 
effectiveness of the devices.
    The special control, the draft guidance entitled ``Premarket 
Notification (510(k)) Guidance Document for Contact Lens Care 
Products,'' sets forth the tests and information that FDA believes are 
needed to ensure the continued safety and effectiveness of contact lens 
care products. The guidance is organized into product specific sections 
that describe the information that addresses the risks associated with 
use of each device. In addition, the guidance will enable a 
manufacturer of a contact lens care product to conduct the necessary 
preclinical and clinical testing recommended in a 510(k) premarket 
notification to demonstrate substantial equivalence of the device to a 
legally marketed contact lens care product (predicate device).
    The draft guidance outlines the types of manufacturing and 
chemistry, toxicology, and microbiology testing that should be 
completed for each device, and contains a summary of the basic 
requirements and suggested methods for meeting these preclinical 
requirements. If the results of preclinical testing demonstrate that 
the device will have new characteristics, clinical performance data may 
be needed to establish substantial equivalence. If clinical performance

[[Page 14280]]
data are needed, the draft guidance document provides suggested 
methodologies (e.g., size and scope of the study) to be included in the 
investigational protocol. This draft guidance document also provides 
general and product specific labeling guidance that identifies 
warnings, precautions, and directions for use that further address the 
risks associated with the use of these devices.
    Other elements of the draft guidance include: (1) General 
information on the regulations and requirements for labeling contact 
lens care products; (2) information about 510(k) requirements relating 
to modifying a marketed contact lens care product; and (3) guidance for 
submitting a 510(k) for contact lens cases and contact lens accessories 
(i.e., mechanical cleaning aids and accessory cleaning pads).
    The draft guidance explains that, in the event that clinical trials 
are necessary, manufacturers must conduct the trials in accordance with 
the investigational device exemption regulations in 21 CFR part 812. At 
this time, FDA considers clinical studies of most contact lens care 
products to be nonsignificant risk investigations. For nonsignificant 
risk investigations, approval of an institutional review board (IRB) is 
necessary before initiating a clinical study, and an investigational 
plan and informed consent document must be presented to an IRB for 
review and approval. Prior FDA approval is not required. However, FDA 
considers most clinical studies of solutions that contain new active 
ingredients for ophthalmic use and are intended for use directly in the 
eye to be significant risk investigations that would require both IRB 
and FDA review and approval.

VI. 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.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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 
proposal on small entities. Because this proposal would reduce the 
regulatory burdens for all manufacturers of contact lens care products 
covered by this proposal, the agency certifies that the proposed 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 proposes to amend the regulations in 
Secs. 886.5918, 886.5928, and 886.5933 as set forth below.

VIII. Effective Date

    FDA is proposing that any final rule that may issue based on this 
proposed rule become effective 30 days after date of publication of the 
final rule in the Federal Register.

IX. Comments

    Interested persons may, on or before June 17, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above, between 9 
a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 886 be 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: 
``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 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: 
``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: March 18, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-7784 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-F