[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Rules and Regulations]
[Pages 22012-22016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08940]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2013-N-0069]
Medical Devices; Ophthalmic Devices; Classification of the Eyelid
Weight
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
classifying the eyelid weight into class II (special controls). The
Agency is exempting the external eyelid weight from premarket
notification, but continuing to require premarket notification for
implantable eyelid weights in order to provide a reasonable assurance
of safety and effectiveness of the device. Both external and
implantable eyelid weight devices are subject to special controls. The
eyelid weight may be adhered to the outer skin of the upper eyelid
(external eyelid weight) or implanted into the upper eyelid
(implantable eyelid weight), and is intended for the gravity assisted
treatment of lagophthalmos (incomplete eyelid closure).
DATES: Effective Date: July 21, 2014.
Compliance Dates: Premarket notification submissions (510(k)s) for
[[Page 22013]]
eyelid weights filed on or after the effective date of this rule are
expected to comply with the requirement of special controls at the time
that the 510(k) is submitted.
Premarket notification submissions (510(k)s) for eyelid weights
filed before the effective date of this rule, but not yet cleared for
marketing, are expected to comply with the requirement of special
controls prior to receiving marketing clearance.
External eyelid weights exempt from premarket notification under
this rule and not currently marketed are expected to comply with the
requirement of special controls prior to introducing devices into
interstate commerce.
Eyelid weights (both implantable and external) legally marketed
before the effective date of this rule are expected to comply with the
requirement of special controls by April 21, 2015. See section V of
this document, ``Compliance Dates,'' for further information.
FOR FURTHER INFORMATION CONTACT: Tina Kiang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002, 301-796-6860,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
301 et seq.), as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(Pub. L. 101-629), the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food
and Drug Administration Safety and Innovation Act (Pub. L. 112-144),
among other amendments, established a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
Under section 513 of the FD&C Act, FDA refers to devices that were
in commercial distribution before May 28, 1976 (the date of enactment
of the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the Agency takes the following steps: (1) Receives
a recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These devices are
classified automatically by statute (section 513(f) of the FD&C Act)
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until: (1) FDA
reclassifies the device into class I or II; (2) FDA issues an order
classifying the device into class I or II in accordance with section
513(f)(2) of the FD&C Act, as amended by FDAMA; or (3) FDA issues an
order finding the device to be substantially equivalent, under section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 of the regulations (21 CFR part 807).
A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that a
class II device may be exempted from the premarket notification
requirements under section 510(k) of the FD&C Act, if the Agency
determines that premarket notification is not necessary to assure the
safety and effectiveness of the device.
II. Regulatory History of the Device
In the Federal Register of February 8, 2013 (78 FR 9349), FDA
proposed to classify eyelid weight devices intended for the gravity-
assisted treatment of lagophthalmos (incomplete eyelid closure) into
class II (special controls) and proposed special controls for these
devices. FDA also proposed to exempt the devices from premarket
notification requirements if the device is an external eyelid weight.
FDA invited interested persons to comment on the proposed regulation by
May 9, 2013. FDA received three comments on the proposed rule.
III. Summary of the Final Rule
In accordance with 21 CFR 860.84(g)(2), FDA is classifying eyelid
weights into class II (special controls). FDA is codifying the
classification of eyelid weights by adding Sec. 886.5700.
A. External Eyelid Weights
Under section 510(m) of the FD&C Act, FDA has determined that
premarket notification is not necessary to assure the safety and
effectiveness of external eyelid weights, and the Agency is exempting
these devices from premarket notification requirements. The Agency has
also identified special controls for these devices. On or before the
effective date of this final rule, firms who wish to market external
eyelid weight devices that are not already legally marketed are
required to either (1) comply with the particular mitigation measures
set forth in the special controls in Sec. 886.5700(b)(1) or (2) use
alternative mitigation measures, but demonstrate to the Agency's
satisfaction that those alternative measures identified by the firm
will provide at least an equivalent assurance of safety and
effectiveness. As discussed in sections IV and V, in response to
comments regarding compliance with the special controls for existing
legally marketed devices, FDA has extended the compliance date for
special controls to 1 year from the effective date of this rule to
allow manufacturers of existing legally marketed devices adequate time
to review the design history files and complete any needed testing and
implement any required labeling changes for their devices.
FDA also made changes to the final rule as related to external
eyelid weights in response to the comments and for clarification.
Proposed Sec. 886.5700(b)(1)(iii) has been edited to remove the words
``required for the safe and effective use of the device as outlined in
Sec. 801.109(c) of this chapter'' to minimize any confusion since this
section describes special controls and the labeling requirements in 21
CFR part 801 are a general control. FDA also removed the special
controls for external eyelid weights related to magnetic resonance (MR)
compatibility testing (see additional discussion in section IV).
B. Implantable Eyelid Weights
FDA has determined that premarket notification is necessary to
provide
[[Page 22014]]
reasonable assurance of safety and effectiveness of implantable eyelid
weights, and, therefore, this device type is not exempt from premarket
notification requirements. The Agency has also identified special
controls for these devices. On or before the effective date of this
final rule, firms who wish to market external eyelid weight devices
that are not already legally marketed are required to either (1) comply
with the particular mitigation measures set forth in the special
controls in Sec. 886.5700(b)(2) or (2) use alternative mitigation
measures, but demonstrate to the Agency's satisfaction that those
alternative measures identified by the firm will provide at least an
equivalent assurance of safety and effectiveness. As discussed in
section IV, in response to comments regarding compliance with the
special controls for existing legally marketed devices, FDA has
extended the compliance date for special controls to 1 year from the
effective date of this rule to allow manufacturers of existing legally
marketed devices adequate time to review the design history files and
complete any needed testing and implement any required labeling changes
for their devices.
IV. Analysis of Comments and FDA's Response
FDA received three comments on the proposed rule. One of the
comments was supportive of FDA's proposed rule, including the
classification and the special controls for both the external and
implantable eyelid weights and the exemption of external eyelid weights
from premarket notification requirements (510(k)). A second comment
agreed with the proposed classification into class II, but indicated
that the risks associated with long-term use of external eyelid weights
were similar to those for implantable eyelid weights, and that as such
external eyelid weights should not be exempted from the premarket
notification requirements. FDA disagrees with the comment. FDA believes
that the identified special controls adequately mitigate the risks to
health for the device regardless of the duration of use. The increased
risks associated with implanted eyelid weights are related to the need
for the device to be provided sterile and the increased
biocompatibility requirements. These risks are significantly reduced
with external eyelid weight devices. FDA believes that compliance with
the special controls in Sec. 886.5700(b)(1) provides a reasonable
assurance of safety and effectiveness for external eyelid weight
devices without the need for premarket notification.
The third comment requested clarification on whether existing
eyelid weight manufacturers (for both implantable and external eyelid
weight devices) need to address the identified special controls. The
special controls established in this rule apply to existing legally
marketed devices, as well as to new eyelid weight devices not currently
marketed for which marketing authority is sought and to any
modification of a currently legally marketed eyelid weight. In response
to this comment, FDA has extended the compliance date for special
controls for manufacturers of existing legally marketed devices to 1
year from the effective date of this rule, as outlined in section V,
``Compliance Dates.''
Submission of a new 510(k) solely to demonstrate conformance to the
special controls is not needed unless complying with the special
controls leads to changes to the device that would independently
trigger the need for a new 510(k) under Sec. 807.81(a)(3). However,
manufacturers should maintain documentation in their design history
file (see Sec. 820.30 (21 CFR 820.30)) to demonstrate that they meet
the special controls. To ensure that manufacturers of existing legally
marketed devices have adequate time to review their design history
files and complete any needed testing and implement any required
labeling changes for their devices, FDA has extended the compliance
date for existing legally marketed devices to comply with the special
controls to 1 year after the effective date of this final rule.
Manufacturers with questions regarding their existing devices are
encouraged to interact with FDA via the pre-submission process.
The third comment further suggested that the biocompatibility
testing requirements as described in the proposed special controls are
more extensive and burdensome than the requirements under which
existing legally marketed eyelid weights devices were originally
reviewed. The comment stated that, for external eyelid weights, limited
biocompatibility testing with supportive literature review and
reference to material in predicate devices should be acceptable in lieu
of a full battery of biocompatibility testing. FDA agrees that based on
the material and manufacturing processes being used, a full battery of
biocompatibility testing may not be required. Discussion of the
specific biocompatibility testing requirements for existing legally
marketed eyelid weight devices is beyond the scope of this rule;
however, FDA encourages manufacturers to review existing Agency
guidance on this topic and contact FDA via the pre-submission process
to discuss specific biocompatibility requirements for their devices.
The third comment further requested clarification on whether a
labeling change to address MR compatibility would trigger additional
compliance expectations regarding MR testing and suggested that because
external eyelid weights are removable devices, MR compatibility should
not be a requirement for these devices. FDA agrees with the commenter
that removal of the device when the patient is in the MR environment
would mitigate this risk and has thus removed MR testing compatibility
testing as a special control. However, to ensure that the patient is
aware that the device should be removed in these circumstances, the
special control regarding labeling has been revised to include a
requirement for a warning stating that the patient should be instructed
to remove the device prior to entering an MR environment.
Finally, the third comment also requested clarification on the
special control for implanted eyelid weights: ``testing demonstrating
the sterility and shelf life of the device'' and suggested that the
shelf life of the implanted device is limited by the ability of the
associated packaging to maintain a protective barrier and not by the
device itself, and therefore, validated packaging and sterilization
procedures would satisfy this requirement. Although FDA agrees that
validation of the packaging and sterilization processes is important to
comply with this special control, each manufacturer must assess the
materials and processes used to manufacture their device when
determining the testing necessary to provide assurance that the
sterility and functionality of the device are maintained over its shelf
life.
V. Compliance Dates
This final rule will become effective July 21, 2014.
The special controls established in this rule for external eyelid
weights and the special controls established in this rule for
implantable eyelid weights apply to any external or implantable eyelid
weight respectively, whether the device is an existing legally marketed
device, a new eyelid weight device not currently marketed for which
marketing authority is sought, or a modification of a currently legally
marketed eyelid weight. Devices of this type that were legally marketed
before the effective date of this rule may continue to be legally
marketed; however 1 year after the effective date of this rule, such
[[Page 22015]]
devices must comply with applicable special controls in order to
continue to be legally marketed. Submission of a new 510(k) solely to
demonstrate conformance to the special controls is not needed unless
complying with the special controls leads to changes to the device that
would independently trigger the need for a new 510(k) under Sec.
807.81(a)(3). However, manufacturers should maintain documentation in
their design history file (see Sec. 820.30(j)) to demonstrate that
they meet the special controls. One year after the effective date of
this rule, any external eyelid weight that does not comply with the
special controls established in Sec. 886.5700(b)(1) or implantable
eyelid weight that does not comply with the special controls
established in Sec. 886.5700(b)(2) this rule will be considered
adulterated and misbranded (sections 501(f)(1)(B) and 502(o) of the
FD&C Act (21 U.S.C. 351(f)(1)(B) and 352(o)) until such time as the
device: (1) Complies with the special controls and any premarket
notification requirements; (2) is approved in a PMA application; or (3)
is classified into class I or II under section 513(f)(2) or (3) of the
FD&C Act.
A 510(k) submission for an eyelid weight either filed before the
effective date of this rule, but not yet cleared for marketing or filed
after the effective date of this rule may be cleared for marketing only
if the device complies with the special controls established for this
device type. The submitter may demonstrate that the special controls
have been met by incorporating previously submitted information by
reference, or by providing newly generated information. A submitter's
first 510(k) submission for an implantable eyelid weight filed
following the publication of this final rule should be a traditional
510(k) submission. Filing of a special 510(k) submission for a modified
implantable eyelid weight is only appropriate after FDA has cleared an
initial 510(k) submission that establishes that the device complies
with the special controls established for the device type.
VI. Environmental Impact
The Agency has determined under 21 CFR 25.34(b) 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 final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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 not a significant
regulatory action under Executive Order 12866.
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 regulation classifies a previously
unclassified pre-amendment device type, there are only five registered
establishments listed in the Establishment Registration and Device
Listing database, and the regulation designating the classification of
eyelid weights as class II is consistent with the historical regulatory
oversight given to this device type, the Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VIII. Paperwork Reduction Act of 1995
This final rule establishes special controls that refer to
currently approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485.
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
0
1. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 886.5700 to subpart E to read as follows:
Sec. 886.5700 Eyelid weight.
(a) Identification. An eyelid weight is a prescription device made
of gold, tantalum, platinum, iridium, or surgical grade stainless steel
that is rectangular in shape and contoured to the shape of the eye. The
device is intended for the gravity assisted treatment of lagophthalmos
(incomplete eyelid closure).
(1) The external eyelid weight is adhered to the outer skin of the
upper eyelid.
(2) The implantable eyelid weight is implanted into the upper
eyelid.
(b) Classification. (1) Class II (special controls) for the
external eyelid weight. The external eyelid weight is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 886.9. The special controls
for the external eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing,
and removal of the device; and
(B) A warning stating that the patient should be instructed to
remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight.
The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the
device;
(iii) Nonclinical testing evaluating the compatibility of the
device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety
and compatibility of the device in a magnetic resonance environment,
the conditions under which a patient with
[[Page 22016]]
the device can be safely scanned, and a mechanism for a healthcare
provider to obtain detailed information about magnetic resonance safety
and compatibility if needed.
Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08940 Filed 4-18-14; 8:45 am]
BILLING CODE 4160-01-P