[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Rules and Regulations]
[Page 43144-43146]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au07-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 2007N-0267]
Medical Devices; General and Plastic Surgery Devices;
Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture
Produced by Recombinant DNA Technology
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
absorbable poly(hydroxybutyrate) surgical suture produced by
recombinant deoxyribonucleic acid (DNA) technology into class II
(special controls). The special control that will apply to the device
is the guidance document entitled ``Class II Special Controls Guidance
Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by
Recombinant DNA Technology.'' The agency is classifying these devices
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of these devices. Elsewhere in
this issue of the Federal Register, FDA is announcing the availability
of the guidance document that will serve as the special control for
this device.
DATES: This rule is effective September 4, 2007. The classification was
effective February 8, 2007.
FOR FURTHER INFORMATION CONTACT: Nada O. Hanafi, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3555.
SUPPLEMENTARY INFORMATION:
I. What is the Background of this Rulemaking?
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in
commercial distribution before May 28, 1976, the date of enactment of
the Medical Device Amendments of 1976 (the amendments), generally
referred to as postamendments devices, are classified automatically by
statute into class III without any FDA rulemaking process. These
devices remain in class III and require premarket approval, unless the
device is classified or reclassified into class I or class II, or FDA
issues an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the 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 act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1) of the act, request FDA to classify the device under the
criteria set forth in section 513(a)(1) of the act. FDA shall, within
60 days of receiving such a request, classify the device by written
order. This classification shall be the initial classification of the
device type. Within 30 days after the issuance of an order classifying
the device, FDA will publish a notice in the Federal Register
announcing such classification (section 513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued an
order on November 7, 2005, classifying the absorbable
poly(hydroxybutyrate)
[[Page 43145]]
surgical suture produced by recombinant DNA technology in class III
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device that was
subsequently reclassified into class I or class II. On May 12, 2006,
after Tepha, Inc., had received CDRH's response to an April 7, 2006,
appeal from the company, Tepha, Inc., submitted a petition under
section 513(f)(2) of the act requesting classification of the device.
The manufacturer recommended that the device be classified into class
II (Ref. 1).
In accordance with section 513(f)(2) of the act, FDA reviewed the
petition in order to classify the device under the criteria for
classification set forth in 513(a)(1) of the act. Devices are to be
classified into class II if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
type, absorbable poly(hydroxybutyrate) surgical suture produced by
recombinant DNA technology, can be classified into class II because
special controls, in addition to general controls, are adequate to
provide reasonable assurance of the safety and effectiveness of the
device and that there is sufficient information to establish special
controls to provide such assurance.
The device type is assigned the generic name, ``absorbable
poly(hydroxybutyrate) surgical suture produced by recombinant DNA
technology,'' and is identified as an absorbable surgical suture made
of material isolated from prokaryotic cells produced by recombinant DNA
technology. The device is intended for use in general soft tissue
approximation and ligation.
FDA has identified the risks to health associated with this type of
device as: Improper selection and use, suture breakage, adverse tissue
reaction, and infection. The special control FDA is establishing is a
special controls guidance document that FDA believes will aid in
mitigating the potential risks to health, as described in table 1 of
this document.
Table 1.--Risks to Health and Mitigation Measures
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Identified Risk Mitigation Measures
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Improper selection and use Physical and performance
characteristics
Biocompatibility
Labeling
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Suture breakage Physical and performance
characteristics
Expiration dating
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Adverse tissue reaction (i.e., Biocompatibility
irritation, inflammation, immune
response)
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Infection Sterility
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FDA believes that special controls, in addition to general
controls, address the risks to health identified above and provide
reasonable assurances of the safety and effectiveness of the device
type. Thus, on February 8, 2007, FDA issued an order to the petitioner
classifying the device into class II. FDA is codifying this
classification at 21 CFR 878.4494.
Following the effective date of the final classification rule,
manufacturers will need to address the issues covered in the special
controls guidance. However, the manufacturer need only show that its
device meets the recommendations of the guidance or in some other way
provides equivalent assurance of safety and effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, however, FDA has
determined that premarket review of the requirements as outlined in
Sec. 807.87 will provide reasonable assurance of the safety and
effectiveness of the device. Thus, persons who intend to market this
type of device must submit to FDA a premarket notification, prior to
marketing the device, which contains information about the device they
intend to market.
II. What is the Environmental Impact of This Rule?
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. Thus, neither an environmental
assessment nor an environmental impact statement is required.
III. What is the Economic Impact of This Rule?
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 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 not a significant regulatory action 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 classification of this device into class II
will relieve manufacturers of the cost of complying with the premarket
approval requirements of section 515 of the act (21 U.S.C. 360e), and
may permit small potential competitors to enter the marketplace by
lowering their costs, 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 $122 million, using the most current (2005) 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.
IV. Does This Final Rule Have Federalism Implications?
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and
[[Page 43146]]
responsibilities among the various levels of government. Accordingly,
the agency has concluded that the rule does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
V. How Does This Rule Comply with the Paperwork Reduction Act of 1995?
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 is not required. The guidance for this
final rule references previously approved collections of information
found in FDA regulations. These collections of information are subject
to review by the OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
VI. What References Are on Display?
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Tepha, Inc., on May 12, 2006.
List of Subjects in 21 CFR Part 878
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Section 878.4494 is added to subpart E to read as follows:
Sec. 878.4494 Absorbable poly(hydroxybutyrate) surgical suture
produced by recombinant DNA technology.
(a) Identification. An absorbable poly(hydroxybutyrate) surgical
suture is an absorbable surgical suture made of material isolated from
prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA)
technology. The device is intended for use in general soft tissue
approximation and ligation.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate)
Surgical Suture Produced by Recombinant DNA Technology.'' For the
availability of this guidance document see Sec. 878.1(e).
Dated: July 23, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-15064 Filed 8-2-07; 8:45 am]
BILLING CODE 4160-01-S