[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