[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: 94-4696]
[[Page Unknown]]
[Federal Register: March 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. 91N-0291]
Medical Devices; Reclassification and Codification of the Daily
Wear Soft and Daily Wear Nonhydrophilic Plastic Contact Lenses
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is codifying the
reclassification of daily wear soft and daily wear nonhydrophilic
plastic contact lenses from class III (premarket approval) into class
II (special controls). Elsewhere in this issue of the Federal Register
FDA has issued an order of reclassification as 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, elsewhere in this issue of the Federal
Register, in conjunction with the order reclassifying the devices, FDA
is announcing the availability of a guidance document describing those
safeguards in the form of evidence needed to demonstrate the
substantial equivalence of new daily wear soft and daily wear
nonhydrophilic contact lenses to lenses already marketed.
DATES: This codification becomes effective April 4, 1994. The
reclassification action published elsewhere in this issue of the
Federal Register is effective March 4, 1994.
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: Under the Medical Device Amendments of 1976
(Pub. L. 94-295), Congress classified all transitional devices (i.e.,
those devices previously regulated as drugs), including daily wear soft
and daily wear nonhydrophilic plastic contact lenses, into class III
(premarket approval). The SMDA (Pub. L. 101-629), 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 still remaining in
class III to determine if the devices could be down classified into
class II (special controls) or class I (general controls). The SMDA
made further provision with respect to the reclassification of daily
wear soft and daily wear nonhydrophilic plastic contact lenses. Section
4(b)(3)(A) of the SMDA provided that, notwithstanding the provisions
for reclassification of other transitional devices, daily wear soft and
daily wear nonhydrophilic plastic contact lenses would not be retained
in class III unless FDA determined that the devices meet the statutory
criteria for a class III device. Further, if FDA did not determine that
these contact lenses must remain in class III and publish such
determination 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 would 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. As required by section 4(b)(3)(D) of the SMDA,
therefore, FDA has issued an order reclassifying the devices from class
III (premarket approval) into class II (special controls). This order
appears elsewhere in this issue of the Federal Register. In conjunction
with the order, FDA is also issuing a guidance document for premarket
notifications for the reclassified contact lenses, entitled ``Premarket
Notification (510(k)) Guidance Document for Daily Wear Contact
Lenses.''
Pending original and supplemental applications for premarket
approval for daily wear soft or daily wear nonhydrophilic plastic
contact lenses currently filed with the agency must be examined to
identify: (1) Those that are no longer subject to premarket approval
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 not required
to be resubmitted and evaluated as a 510(k) prior to implementing the
request. FDA review of affected premarket approval applications (PMA's)
will be suspended 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. Sponsors of PMA's
affected by the reclassification should refer to the order published
elsewhere in this issue of the Federal Register for information on
actions necessary regarding any pending applications affected by the
automatic reclassification.
Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) 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.
Economic Impact
FDA has carefully examined the costs and benefits of this action in
accordance with the requirements of Executive Order 12866 and the
Regulatory Flexibility Act (Pub. L. 96-354). The agency concludes that
the rule is not a significant rule as defined in Executive Order 12866.
Further, the agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities, as defined
in the Regulatory Flexibility Act. The reclassification will reduce the
regulatory costs to manufacturers of these lenses because the cost of
complying with premarket notification requirements is substantially
less than the cost of complying with premarket approval requirements.
Accordingly, the regulations at Secs. 886.5916 and 886.5925 (21 CFR
886.5916 and 886.5925) are amended as set forth below.
List of Subjects in 21 CFR Part 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:
PART 886--OPHTHALMIC DEVICES
1. The authority section 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 886.5916 is amended by revising paragraphs (b) and (c)
to read as follows:
Sec. 886.5916 Rigid gas permeable contact lens.
* * * * *
(b) Classification. (1) Class II if the device is intended for
daily wear only.
(2) Class III if the device is intended for extended wear.
(c) Date PMA or notice of completion of a PDP is required. As of
May 28, 1976, an approval under section 515 of the act is required
before a device described in paragraph (b)(2) of this section may be
commercially distributed. See Sec. 886.3.
3. Section 886.5925 is amended by revising paragraphs (b) and (c)
to read as follows:
Sec. 886.5925 Soft (hydrophilic) contact lens.
* * * * *
(b) Classification. (1) Class II if the device is intended for
daily wear only.
(2) Class III if the device is intended for extended wear.
(c) Date PMA or notice of completion of a PDP is required. As of
May 28, 1976, an approval under section 515 of the act is required
before a device described in paragraph (b)(2) of this section may be
commercially distributed. See Sec. 886.3.
Dated: February 24, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-4696 Filed 3-3-94; 8:45 am]
BILLING CODE 4160-01-P