[Federal Register Volume 72, Number 149 (Friday, August 3, 2007)]
[Rules and Regulations]
[Pages 43144-43146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15064]


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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
------------------------------------------------------------------------
Suture breakage                      Physical and performance
                                      characteristics
                                     Expiration dating
------------------------------------------------------------------------
Adverse tissue reaction (i.e.,       Biocompatibility
 irritation, inflammation, immune
 response)
------------------------------------------------------------------------
Infection                            Sterility
------------------------------------------------------------------------

    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