[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Rules and Regulations]
[Pages 4164-4165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 812 and 813
[Docket No. 91N-0292]
Investigational Device Exemptions; Intraocular Lenses
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to remove the regulations on investigational device exemptions (IDE's)
for intraocular lenses (IOL's). An IOL is an implant intended to
surgically replace the natural lens of the human eye. FDA believes it
is no longer necessary to maintain particularized regulations on IOL
investigations because approved IOL's are now widely available and
investigations of IOL's can be conducted under the investigational
device regulations applicable to medical devices generally. This action
is intended to eliminate confusion within the clinical research
community and to provide uniformity to investigational device studies.
EFFECTIVE DATE: March 31, 1997.
FOR FURTHER INFORMATION CONTACT: Joanne R. Less, Center for Devices and
Radiological Health (HFZ-403), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has two regulations on investigational use of medical devices.
Part 812 (21 CFR part 812) covers investigational devices generally,
and part 813 (21 CFR part 813) applies only to IOL's. The existence of
a separate regulation for investigational use of IOL's is due to
provisions of the Medical Device Amendments of 1976 (1976 amendments)
(Pub. L. 94-295) that addressed IOL's and to particular issues
surrounding IOL products at that time.
FDA has determined that maintaining two closely related sets of
investigational device regulations is no longer necessary. Thus, FDA
has reexamined the need to retain part 813, and the agency has
concluded that maintaining a regulatory distinction between IOL studies
and studies of other medical devices is no longer justified. Therefore,
in order to eliminate confusion within the clinical research community
and to provide uniformity to investigational device studies, FDA is
removing the IOL regulations in their entirety and removing
Sec. 812.2(c)(8) to exempt IOL's from part 812 when the IOL's are the
subject of an approved premarket approval application under section 515
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e).
In the Federal Register of October 6, 1993 (58 FR 52142), FDA
published a proposed rule to remove the regulations on IOL's. In that
same issue, FDA also proposed procedures for disqualification of
clinical investigators for inclusion in the current general
investigational device regulations. FDA provided an opportunity for
interested persons to submit comments on the proposed removal of the
IOL regulations by December 6, 1993. Subsequently, in the Federal
Register of December 6, 1993 (58 FR 64209), FDA extended the comment
period to January 5, 1994. In a future issue of the Federal Register,
FDA will issue final procedures for disqualification of clinical
investigators as part of the current general investigational device
regulations in part 812.
II. Comments
The agency received two comments in response to the proposal of
October 6, 1993, with respect to IOL's. One of the comments was
submitted by a trade association. The other comment was submitted by a
manufacturer. A
[[Page 4165]]
summary of the comments and the agency's response to them is provided
below:
(1) One comment concurred with FDA's proposal to remove the
separate regulation on IDE's for IOL's contained in part 813. However,
because part 813 contains some provisions that are not reflected in
part 812, the comment suggested that FDA identify what, if any,
additional information FDA would require IDE submissions for IOL's to
include.
Under the final rule, any requirements unique to part 813 would no
longer apply. The content of IDE submissions for IOL's only need to
include information required in IDE submissions for investigational
devices generally. For example, with respect to institutional review
boards (IRB's) (referred to in part 813 as institutional review
committees), the sponsor will only be required to submit the
information required by Sec. 812.20(b)(6) and not that required by
Sec. 813.20(b)(7).
(2) Both comments recommended that FDA provide in the final rule a
mechanism for IOL clinical investigations that are in progress before
the final rule becomes effective to continue under part 813 until those
investigations are completed or terminated. One comment also noted
that, because investigators have not signed statements agreeing to
conform to part 812, application of the requirements of part 812 to
ongoing IOL studies would create confusion and add to the cost of the
ongoing studies.
FDA does not believe that the continuation of part 813
requirements for existing studies is necessary. The differences between
parts 812 and 813 are relatively minor. Investigators who are in
compliance with part 813 will also generally be in compliance with part
812. Sponsors may seek a waiver under part 812, if there are any
difficulties as a result of the change from part 813 to part 812. FDA,
however does not anticipate any difficulties.
(3) Both comments emphasized that part 812 has certain requirements
that are not included in part 813. For example, Sec. 812.150(b)(4)
requires the sponsor to submit a semi-annual investigator list to FDA;
Sec. 812.150(b)(5) requires the sponsor to submit annual progress
reports to all reviewing IRB's; and Sec. 812.150(b)(8) requires the
sponsor to submit to FDA a copy of any report by an investigator under
Sec. 812.150(a)(5) within 5 working days of receipt. Both comments
requested that these additional rules not be imposed on IOL studies
conducted under part 812.
FDA does not believe that maintaining this type of distinction is
necessary. Experience over the past 15 years has shown that the
requirements of part 812 are reasonable and that sponsors of
investigations under part 812 have not had undue difficulty complying
with these provisions. As noted in section II (2) of this document,
part 812 contains a waiver provision that can be utilized on a case-by-
case basis, if needed.
(4) One comment asked how IRB's would be notified of the new rule.
FDA will send letters to sponsors of all active IOL IDE
investigations, and the agency will request that sponsors inform
investigators and IRB's of the change. Additionally, FDA will publicize
the new rule at the regional IRB meetings and at other appropriate
forums.
III. 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
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 rule
on small entities. Because the final rule removes existing regulations
on investigational studies of IOL's and requires such investigations to
be conducted under the IDE regulations in part 812 applicable to
medical devices generally, the agency certifies that the final rule
will not impose any significant new burdens on sponsors and
investigators of IOL's and 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.
List of Subjects
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 813
Medical devices, Medical research, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, chapter I of
title 21 of the Code of Federal Regulations is amended in 21 CFR parts
812 and 813 as follows:
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
1. The authority citation for 21 CFR part 812 continues to read as
follows:
Authority: Secs. 301, 501, 502, 503, 505, 506, 507, 510, 513-
516, 518-520, 701, 702, 704, 721, 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331, 351, 352, 353, 355, 356, 357, 360,
360c-360f, 360h-360j, 371, 372, 374, 379e, 381); secs. 215, 301,
351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241,
262, 263b-263n).
Sec. 812.2 [Amended]
2. Section 812.2 Applicability is amended by removing paragraph
(c)(8).
PART 813--INVESTIGATIONAL EXEMPTIONS FOR INTRAOCULAR LENSES
Part 813 [Removed and Reserved]
3. Part 813, consisting of Secs. 813.1 through 813.170, is removed
and reserved.
Dated: January 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-2169 Filed 1-28-97; 8:45 am]
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