[Federal Register Volume 59, Number 43 (Friday, March 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4697]
[[Page Unknown]]
[Federal Register: March 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93D-0441]
Medical Devices; Reclassification of the Daily Wear Soft and
Daily Wear Nonhydrophilic Plastic Contact Lenses; Premarket
Notification (510(k)) Guidance Document for Daily Wear Contact Lenses;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
reclassifying daily wear soft and daily wear nonhydrophilic plastic
contact lenses from class III (premarket approval) into class II
(special controls). This reclassification is required by the Safe
Medical Devices Act of 1990 (the SMDA). This reclassification only
applies to daily wear soft and daily wear nonhydrophilic contact
lenses. Lenses intended for extended wear will remain in class III, as
will contact lens accessories. The SMDA also requires FDA to put into
place any regulatory safeguards that are necessary to provide
reasonable assurance of the safety and effectiveness of the
reclassified lenses. Thus, FDA is announcing the availability of a
guidance document entitled ``Premarket Notification (510(k)) Guidance
Document for Daily Wear Contact Lenses.'' The guidance sets forth the
evidence that should be submitted to FDA to demonstrate the substantial
equivalence of new daily wear soft and daily wear nonhydrophilic
plastic contact lenses to lenses already marketed. Elsewhere in this
issue of the Federal Register, FDA is publishing a final rule to codify
the reclassification of the daily wear contact lens from class III
(premarket approval) into class II (special controls).
DATES: The reclassification is effective March 4, 1994. Written
comments on the guidance document may be submitted at any time.
ADDRESSES: Submit all amendments to pending premarket approval
applications (PMA's), including the PMA or PMA supplement number, to
the Food and Drug Administration, Center for Devices and Radiological
Health, PMA Document Mail Center (HFZ-401), 1390 Piccard Dr.,
Rockville, MD 20850. Submit written requests for single copies of
``Premarket Notification (510(k)) Guidance Document for Daily Wear
Contact Lenses'' to the Division of Small Manufacturers Assistance
(HFZ-220), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-443-6597 or 800-638-2041. Send two self-addressed
adhesive labels to assist that office in processing your requests.
Submit written comments on the guidance document to the Dockets
Management Branch (HFA-350), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should
be identified with the docket number found in brackets in the heading
of this document. The guidance document and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: David M. Whipple, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-2205.
SUPPLEMENTARY INFORMATION:
I. The Statutory Requirements
The SMDA (Pub. L. 101-629), which amended the medical device
provisions of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 321-394) contained specific provisions on transitional devices
(i.e., those devices regulated as drugs before the Medical Device
Amendments of 1976 (Pub. L. 94-295) became law) (see section 520(l) of
the act (21 U.S.C. 360j(l))). In 1976, Congress classified all
transitional products, including daily wear soft and daily wear
nonhydrophilic plastic contact lenses, into class III (premarket
approval). Essentially the SMDA, reflecting congressional concern that
many transitional devices were being over regulated in class III,
directed FDA to collect certain safety and effectiveness information
from the manufacturers of transitional devices and review the
classifications of those transitional devices that still remained in
class III to determine if the devices could be down classified to class
II (special controls) or class I (general controls).
Under section 520(l)(5)(B) of the act, FDA was to publish
regulations by December 1, 1992, either leaving the transitional class
III devices in class III or revising their classifications down to
class I or class II. However, as permitted by section 520(l)(5)(c) of
the act, the agency, in the Federal Register of November 30, 1992 (57
FR 56586), published a notice extending the period for issuing such
regulations until December 1, 1993.
With respect to the reclassification of daily wear soft and daily
wear nonhydrophilic plastic contact lenses, however, the SMDA makes
further provision. Section 4(b)(3)(A) of the SMDA provides that
notwithstanding the provisions for reclassification of other
transitional devices, FDA shall not retain daily wear soft or daily
wear nonhydrophilic plastic contact lenses in class III unless the
agency determines that the devices meet the statutory criteria for a
class III device. Moreover, if FDA has not determined that these
contact lenses must remain in class III and published its finding by
November 28, 1993, in the Federal Register, then under section
4(b)(3)(D) of the SMDA, FDA ``shall issue an order placing the lenses
in class II.''
Both the language and legislative history of the SMDA make it clear
that the reclassification of daily wear soft and daily wear
nonhydrophilic contact lenses shall occur as a matter of law unless FDA
published a finding that the devices should remain in class III. FDA
has not made such a finding: FDA believes that the safety and
effectiveness of daily wear soft and daily wear nonhydrophilic plastic
contact lenses can be ensured through specified ``special controls'' as
authorized by the SMDA. Therefore, the agency has not made and
published any finding that daily wear soft and daily wear
nonhydrophilic contact lenses must remain in class III.
II. Order
Therefore, as required by section 4(b)(3)(D) of the SMDA, FDA is
issuing this order to all manufacturers of daily wear soft and daily
wear nonhydrophilic contact lenses reclassifying their devices from
class III (premarket approval) into class II (special controls). The
devices being reclassified are contact lenses intended for daily wear
that meet the following descriptions:
Rigid Gas Permeable Contact Lens. A rigid gas permeable contact
lens is a device intended to be worn directly against the cornea of the
eye to correct vision conditions. The device is made of various
materials, such as cellulose acetate butyrate, polyacrylate-silicone,
or silicone elastomers, whose main polymer molecules generally do not
absorb or attract water.
Soft (Hydrophilic) Contact Lens. A soft (hydrophilic) contact lens
is a device intended to be worn directly against the cornea and
adjacent limbal and scleral areas of the eye to correct vision
conditions or to act as a therapeutic bandage. The device is made of
various polymer materials, the main polymer molecules of which absorb
or attract a certain volume (percentage) of water.
III. Guidance
In addition to issuing this order as required by the SMDA, FDA is
issuing a guidance document for premarket notifications for the
reclassified contact lenses entitled, ``Premarket Notification (510(k))
Guidance Document for Daily Wear Contact Lenses.'' This guidance sets
forth the special controls that FDA has determined are needed to ensure
the safety and effectiveness of daily wear plastic contact lenses. It
also provides comprehensive directions to enable a manufacturer of a
daily wear soft or daily wear nonhydrophilic plastic contact lens to
submit a 510(k) premarket notification demonstrating substantial
equivalence of the device to a legally marketed daily wear plastic
contact lens (predicate device). Information on the battery of
preclinical testing necessary to demonstrate substantial equivalence is
included in the guidance. If the results of preclinical testing
demonstrate the device to have new characteristics, clinical
performance data may be needed to establish substantial equivalence. If
clinical performance data are needed, the guidance document provides
suggested methodologies (e.g., size and scope of the study) to be
included in an investigational protocol.
The preclinical portion of the guidance document consists of
manufacturing and chemistry, toxicology and microbiology sections
outlining the type of testing that should be completed. Each section
includes a summary of the basic requirements and suggested methods for
meeting these requirements. Other elements of the guidance document
include: (1) General information on the regulations and requirements
for labeling contact lenses; (2) requirements that must be met prior to
modifying a marketed contact lens; (3) suggested methodologies for
meeting color additive requirements; (4) procedures for adding lens
finishing laboratories for manufacturing and marketing of class II
rigid gas permeable contact lenses; and (5) the procedure for
implementing changes in packaging materials.
In the event that clinical trials are necessary, FDA emphasizes
that 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 daily wear soft or daily
wear nonhydrophilic plastic contact lenses to be nonsignificant risk
investigations. FDA considers clinical studies of extended wear contact
lenses to be significant risk investigations. Thus, for daily wear soft
or daily wear nonhydrophilic plastic contact lenses, an institutional
review board (IRB) approval is always necessary before initiating a
clinical study, and an investigational plan and informed consent
document must be presented to an IRB for review and approval. For
extended wear contact lenses, the manufacturer must obtain both IRB and
FDA approvals in accordance with 21 CFR part 812 before clinical
testing can be initiated.
This guidance document will be discussed at the next meeting of
the Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
The date, time, and place of this meeting will be announced in a future
issue of the Federal Register.
IV. Transition Phase for Pending PMA's for Daily Wear Contact
Lenses
Below, FDA discusses how it will deal with the pending original and
supplemental PMA's involving daily wear soft or daily wear
nonhydrophilic plastic contact lenses 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 applicant to be evaluated through the 510(k) process; and
(2) those which can be withdrawn by the applicant and are 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 ``Premarket
Notification (510(k)) Guidance Document for Daily Wear Contact
Lenses.''
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 automatic reclassification. FDA is
suspending the review of each pending original and supplemental PMA
affected in whole or in part by this reclassification order until the
respective sponsor amends its application setting forth the status of
the devices and the administrative actions requested to be taken
regarding its application.
These administrative actions can include the following:
(1) For a pending PMA that involves only contact lenses covered by
this reclassification, the sponsor may ask that its PMA application be
converted, in total, to a 510(k) application.
The amendment to the PMA should include all of the necessary
content requirements for a 510(k), thus making the application as
complete as possible when it is converted to a 510(k). For example, if
an applicant has a pending PMA supplement for a modification to a
previously approved daily wear contact lens, and if this modification
has been identified in the ``Premarket Notification (510(k)) Guidance
Document for Daily Wear Contact Lenses'' as a change requiring
submission of a 510(k), the applicant can amend this PMA with a request
to convert it into a 510(k). PMA's converted to 510(k)'s under this
order will retain their position in the review queue (if they are
complete), and the review process will continue without further delay.
(2) For a pending PMA that involves both lenses that are covered by
this reclassification and those that are not, the applicant should
withdraw the portion of the application that addresses the reclassified
lenses and resubmit it as a 510(k) application.
For example, if a pending PMA contains a request for a new or
modified lens material for both a daily and extended wear contact lens,
the applicant should withdraw the request for the daily wear lens and
ask the agency to proceed with the review of that portion of the PMA
involving the extended wear contact lens only. Pending PMA's that must,
in part, be resubmitted as a 510(k) application will retain their
position in the review queue if the applicant responds with the
appropriate amendment and clearly states in the amendment that the
daily wear contact lens portion of the PMA will be resubmitted as a
510(k) application.
Whichever option applies, the applicant should determine whether
the previous request involving the daily wear contact lens must be
resubmitted and evaluated through the 510(k) process or be implemented
without the need for submission of a 510(k). To make this
determination, the applicant should consult the 510(k) procedures (21
CFR part 807) and the ``Premarket Notification (510(k)) Guidance
Document for Daily Wear Contact Lenses.'' If the applicant determines
that a 510(k) application is required, the sponsor should resubmit the
application following the content and format requirements for 510(k)
applications. The agency notes that preclinical and clinical data
formerly required in the PMA may still be necessary to support a
substantial equivalence determination. Preclinical and clinical data
which is also contained in a pending PMA may be incorporated by
reference in a 510(k) application. The applicant should include in the
amendment the claim of substantial equivalence to their previously
approved daily wear contact lens and a summary of the safety and
effectiveness information or a statement that the applicant will make
the safety and effectiveness information available to interested
persons upon request.
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) applications before simply converting PMA's to 510(k)
applications since the disclosure regulations may treat information in
the applications differently. For this reason, a manufacturer may
choose not to have the pending PMA converted to a 510(k) application,
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) application.
If an applicant fails to submit an amendment as outlined above
within 180 days, FDA will consider the pending PMA or PMA supplement to
be voluntarily withdrawn. In such cases, the agency will notify the
applicant 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 (address above).
Additional questions regarding the administrative procedures
resulting from this reclassification order should be directed to the
PMA Staff (Kathy Lundsten, 301-594-2186), or to the Division of
Ophthalmic Devices, Contact Lens Branch (David M. Whipple, 301-594-
2205, or James F. Saviola, 301-594-1744).
Dated: February 24, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-4697 Filed 3-3-94; 8:45 am]
BILLING CODE 4160-01-F