[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