[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availability of a draft guidance describing the evidence that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