[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Proposed Rules]
[Pages 5327-5330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01447]
[[Page 5327]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA-2012-N-1238]
Medical Devices; Ophthalmic Devices; Classification of the
Scleral Plug
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to classify the scleral plug into class II (special controls), and
proposing to exempt the scleral plugs composed of surgical grade
stainless steel (with or without coating in gold, silver, or titanium)
from premarket notification (510(k)) and to continue to require
premarket notification (510(k)) for all other scleral plugs in order to
provide a reasonable assurance of safety and effectiveness of the
device. The scleral plug is a prescription device used to provide
temporary closure of a scleral incision during an ophthalmic surgical
procedure.
DATES: Submit either electronic or written comments by April 25, 2013.
See section IV of this document for the proposed effective date of a
final rule that may issue based on this proposal.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1238, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1238 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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
A. Statutory and Regulatory Authorities
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), 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 (21
U.S.C. 360c(f)) 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 (21 U.S.C. 360c(i)),
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 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 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. FDA has determined that premarket notification is not
necessary to assure the safety and effectiveness of scleral plugs if
the material is a surgical grade stainless steel with or without a
gold, silver, or titanium coating.
B. Regulatory History of the Device
After the enactment of the Medical Device Amendments of 1976, FDA
commenced to identify and classify all preamendments devices, in
accordance with section 513(b) (21 U.S.C. 360c(b)) of the FD&C Act. In
the Federal Register of September 2, 1987 (52 FR 33346), FDA classified
a total of 109 generic types of ophthalmic devices. The scleral plug
was not identified in this initial effort. FDA has regulated scleral
plugs as devices requiring premarket notification (510(k)). Scleral
plugs currently on the market have been determined to be substantially
equivalent to devices that were in commercial distribution prior to May
28, 1976. Currently, FDA regulates scleral plugs as devices requiring
premarket notification (510(k)). There have been ten 510(k) submissions
received and cleared under product code LXP (scleral plugs).
Consistent with the FD&C Act and the regulations, FDA consulted
with the Ophthalmic Devices Panel (the Panel), an FDA advisory
committee, regarding
[[Page 5328]]
the classification of this device type on January 22, 1996 (Ref. 1). At
the panel meeting, the Panel recommended scleral plugs as
classification as class I, 510(k) exempt. Two 510(k) submissions have
been cleared since the panel meeting.
II. Recommendation of the Panel
During a public meeting which was held on January 22, 1996, the
Panel made recommendations regarding the classification and regulatory
controls for the scleral plug. FDA is proposing the following
identification based on the Panel's recommendations and the Agency's
review:
A. Identification
A scleral plug is a prescription device intended to provide
temporary closure of a scleral incision during an ophthalmic surgical
procedure. These plugs prevent intraocular fluid and pressure loss when
instruments are withdrawn from the eye. Scleral plugs include a head
portion remaining above the sclera, which can be gripped for insertion
and removal, and a shaft that fits inside the scleral incision. Scleral
plugs are removed before completing the surgery. Therefore, they are
generally only used in operating rooms. These devices are often made of
surgical grade stainless steel and can be coated in gold, silver, or
titanium.
Scleral plugs have a long and established history of clinical use.
They are routinely used in many ophthalmic surgeries (specifically,
vitreoretinal surgeries). One common type of vitreoretinal surgery is
vitrectomy. Vitrectomy is estimated to be the third most frequently
performed ophthalmic surgical operation, after cataract and excimer
laser refractive surgery (Ref. 2). Approximately 225,000 vitrectomies
are done in the United States each year (Ref. 2).
B. Recommended Classification of the Panel
Although the Panel was informed that scleral plugs have
historically been treated as class II devices, the Panel recommended
that a scleral plug made of a material previously used in legally
marketed devices be classified into class I (general controls) and be
exempt from premarket notification because the biocompatibility and
ability to be sterilized have already been established. The Panel's
rationale for suggesting that the scleral plug be classified into class
I was because general controls would provide reasonable assurance of
the safety and effectiveness of the device type if it is made from a
material established to be readily sterilized and biocompatible. During
the panel discussion, a distinction was made that scleral plugs
consisting of other materials (i.e., materials that are not already
included in legally marketed medical devices to the date of the
classification regulation) should be classified into class II and
require biocompatibility testing as a special control.
As a result of the distinction between materials used for this
device, the Panel recommended that, unless new materials are proposed,
the device should be exempt from premarket notification.
C. Summary of Reasons for Recommendation
The Panel considered FDA's extensive regulatory experience with the
device type and the Panel members' personal knowledge of and clinical
experience with the device type. The Panel also considered the long
history of safety and effectiveness of the device over many years of
clinical use. The Panel recommended that the scleral plug be classified
into class I because it concluded that general controls would provide
reasonable assurance of the safety and effectiveness of the device type
if it was made from a material established to be readily sterilized and
biocompatible. The Panel also recommended that scleral plugs be exempt
from premarket notification requirements if the proposed device does
not introduce new materials (i.e., materials that are not established
to be safe for this type of application).
However, FDA believes that a class II classification is appropriate
and consistent with the intent of the Panel to establish requirements
(such as biocompatibility and sterility) for these devices. Although
the Panel identified potential risks and the measures that could be
taken to mitigate these risks, the Panel's recommendation of class I
would not permit FDA to establish as special controls the mitigation
measures discussed (biocompatibility, sterility). Therefore, while FDA
is not adopting the Panel's recommendation of classification into class
I, the Agency agrees with the concerns and mitigation measures
discussed by the Panel that would support a classification under class
II.
D. Risks to Health
Based on the Panel's discussion and recommendations and FDA's
experience with the device, the risks to health associated with the
scleral plugs made from surgical grade stainless steel with or without
gold, silver, or titanium coating and the proposed measures to mitigate
these risks are identified in table 1 of this document.
Table 1--Health Risks and Mitigation Measures for the Scleral Plug Made
From Surgical Grade Stainless Steel
[With or without a gold, silver, or titanium coating]
------------------------------------------------------------------------
Identified risk Mitigation measures
------------------------------------------------------------------------
Infection................................. Sterility Testing.
Adverse Tissue Reaction................... Biocompatibility Testing.
Loss, breakage, or migration of the plug.. Labeling.
------------------------------------------------------------------------
For scleral plugs that are made of surgical grade stainless steel
(with or without a gold, silver, or titanium coating) the following
special controls, in addition to general controls, can address the
risks to health in table 1 of this document and provide reasonable
assurance of safety and effectiveness of the device: (1) Performance
data must demonstrate the sterility and shelf life of the device; (2)
the device must be demonstrated to be biocompatible; and (3) labeling
must include all information required for the safe and effective use of
the device, including specific instructions regarding the proper
incision size, placement, and removal of the device.
Because of the varying properties of other materials and the
potential impact on safety and effectiveness, FDA has identified
additional special controls for devices made of materials other than
surgical grade stainless steel. Based on the Panel's discussion and
recommendations and FDA's experience with the device, the risks to
health associated with the scleral plugs made from materials other than
surgical grade stainless steel and the proposed measures to mitigate
these risks are identified in table 2 of this document.
Table 2--Health Risks and Mitigation Measures for Scleral Plugs Made
From Materials Other than Surgical Grade Stainless Steel
------------------------------------------------------------------------
Identified risk Mitigation measures
------------------------------------------------------------------------
Infection................................. Sterility Testing.
Shelf-life Testing.
Adverse Tissue Reaction................... Biocompatibility testing.
Material characterization.
Performance testing to
determine the level of
extractables.
[[Page 5329]]
Loss, breakage, or migration of the plug.. Material characterization.
Performance testing for
Mechanical Properties.
Labeling.
------------------------------------------------------------------------
The Agency believes that the following special controls, in
addition to general controls, will provide reasonable assurance of
safety and effectiveness for scleral plugs that are composed of a
material other than surgical grade stainless steel, as outlined in
table 2: (1) Performance data must demonstrate the sterility and shelf
life of the device; (2) the device must be demonstrated to be
biocompatible; (3) characterization of the device materials must be
performed; (4) performance data must demonstrate acceptable mechanical
properties under simulated clinical use conditions including insertion
and removal of the device; (5) performance data must demonstrate
adequately low levels of the extractables or residues from
manufacturing (or processing) of the device; and (6) labeling must
include all information required for the safe and effective use of the
device, including specific instructions regarding the proper incision
size, placement, and removal of the device. In addition, the scleral
plug is a prescription device and must be used in accordance with 21
CFR 801.109.
III. Proposed Classification and FDA's Finding
Adverse events involving scleral plugs are rare, as evidenced by
the fact that FDA identified only a single adverse event in our
reporting systems and two adverse events in the published literature
(Refs. 3 and 4). The one adverse event reported to FDA resulted in no
persistent adverse effects to the patient and, according to the report,
this specific type of non-metallic scleral plug was discontinued and
replaced with surgical grade stainless steel scleral plugs.
FDA believes that a class II classification is consistent with the
intent of the Panel to establish requirements (such as biocompatibility
and sterility) for these devices. The identified special controls
mitigate the known risks of the device that were identified by the
Panel. However, the FDA does not agree with the Panel that all
materials included in legally marketed scleral devices can be exempted
from 510(k) due to the potential for safety concerns in some materials
that will require specific material information and performance data to
provide a reasonable assurance of safety and effectiveness. FDA
believes this type of information should be reviewed by FDA prior to a
device being marketed in the United States.
FDA proposes the scleral plug be classified into class II. The
special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device. FDA
also agrees, in part, with the Panel's recommendation that premarket
notification is not necessary to assure the safety and effectiveness of
scleral plugs if new materials are not introduced and, therefore, the
Agency is giving notice of intent to exempt the scleral plug device
from premarket notification requirements if the device is made from
surgical grade stainless steel (with or without a gold, silver, or
titanium coating).
IV. Proposed Effective Date
FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.
V. 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.
VI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and 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 proposed rule is not a
significant regulatory action as defined by 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 proposed regulation will classify a
previously unclassified pre-Amendment device type, there are only five
registered establishments listed in the Establishment Registration and
Device Listing database, and the proposed regulation designating the
classification of scleral plugs as class II is consistent with the
historical regulatory oversight given to this device type, the Agency
proposes to certify 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 $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
The proposed rule would impact current manufacturers if they were
to make changes to their existing products and any manufacture wanting
to market a new scleral plug. If the new or changed product is made of
surgical grade stainless steel with or without gold, silver, or
titanium coating, manufacturers could begin marketing after they
complied with the proposed special controls. They would not need to
submit an application to the Agency for preapproval. There would be no
change from current requirements for new products made of alternative
materials; they would need premarket notification before marketing.
VII. Paperwork Reduction Act of 1995
This proposed 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
[[Page 5330]]
number 0910-0485; the collections of information in 21 CFR part 807
have been approved under OMB control number 0910-0387.
VIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday and
are available electronically at http://www.regulations.gov. (FDA has
verified the Web site addresses of the following references, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
1. Transcript from the Food and Drug Administration Ophthalmic
Devices Panel Meeting, January 22, 1996.
2. Chang, Stanley, ``LXII Edward Jackson Lecture: Open Angle
Glaucoma After Vitrectomy,'' American Journal of Ophthalmology, vol.
141(6): pp. 1033-1043, June 2006, available at http://www.sciencedirect.com/science/article/pii/S0002939406002546.
3. Stewart, M. W., ``Intraoperative Radiographic Detection of a
`Lost' Scleral Plug,'' Retina, vol. 25(4): pp. 526-527, June 2005.
4. Bovino, J. A. and D. F. Marcus, ``Intraocular Foreign-Body
Hazard During Vitrectomy,'' American Journal of Ophthalmology, vol.
93 (3): p. 366, March 1982.
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, FDA proposes
to amend part 886 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. In subpart E, add Sec. 886.4155 to read as follows:
Sec. 886.4155 Scleral plug.
(a) Identification. A scleral plug is a prescription device
intended to provide temporary closure of a scleral incision during an
ophthalmic surgical procedure. These plugs prevent intraocular fluid
and pressure loss when instruments are withdrawn from the eye. Scleral
plugs include a head portion remaining above the sclera, which can be
gripped for insertion and removal, and a shaft that fits inside the
scleral incision. Scleral plugs are removed before completing the
surgery.
(b) Classification. Class II (special controls). The special
controls for the scleral plug are:
(1) The device is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to the limitations in
Sec. 886.9 if the material is a surgical grade stainless steel with or
without a gold, silver, or titanium coating. The special controls for
the surgical grade stainless steel scleral plug (with or without a
gold, silver, or titanium coating) are:
(i) The device must be demonstrated to be sterile during the
labeled shelf life;
(ii) The device must be demonstrated to be biocompatible; and
(iii) Labeling must include all information required for the safe
and effective use of the device, including specific instructions
regarding the proper sizing, placement, and removal of the device.
(2) The device is not exempt from premarket notification procedures
if it is composed of a material other than surgical grade stainless
steel (with or without a gold, silver, or titanium coating). The
special controls for scleral plugs made of other materials are:
(i) The device must be demonstrated to be sterile during the
labeled shelf life;
(ii) The device must be demonstrated to be biocompatible;
(iii) Characterization of the device materials must be performed;
(iv) Performance data must demonstrate acceptable mechanical
properties under simulated clinical use conditions including insertion
and removal of the device;
(v) Performance data must demonstrate adequately low levels of the
extractables or residues from manufacturing (or processing) of the
device; and
(vi) Labeling must include all information required for the safe
and effective use of the device, including specific instructions
regarding the proper sizing, placement, and removal of the device.
Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01447 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P