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

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availability of a draft guidance describing the evidence that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