Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Rules and Regulations 8117 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2012–N–0091] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Endovascular Suturing System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

endovascular suturing system into class 

II (special controls). The Agency is 

classifying the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. 

DATES: This rule is effective March 15, 

2012. The classification was effective on 

November 21, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Robert Gill, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1547, Silver Spring, 

MD, 20993–0002, 301–796–6373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C 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), 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 and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with 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 (21 

U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

November 12, 2010, classifying the 

EndoStapling System into 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 which was subsequently 

reclassified into class I or class II. On 

December 10, 2010, Aptus Endosystems, 

Inc. submitted a petition requesting 

classification of the EndoStapling 

System under section 513(f)(2) of the 

FD&C Act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices 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 can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name endovascular suturing system, 

and it is identified as a medical device 

intended to provide fixation and sealing 

between an endovascular graft and the 

native artery. The system is comprised 

of the implant device and an 

endovascular delivery device used to 

implant the endovascular suture. 

FDA has identified the following risks 

to health associated with this type of 

device and the measures required to 

mitigate these risks: 

IDENTIFIED RISKS AND PROPOSED MITIGATION MEASURES

Identified risk Recommended mitigation measures 

Adverse tissue reaction ............................................................................................................................ Biocompatibility Labeling 

Infection .................................................................................................................................................... Sterility and Shelf Life Testing 

Incompatibility with endograft ................................................................................................................... Bench testing 

Migration or fracture of the endovascular suture ..................................................................................... Bench testing 

Animal testing 

Clinical evaluation 

Imaging Incompatibility ............................................................................................................................. Bench testing 

Labeling 

Electromagnetic incompatibility ................................................................................................................ Electromagnetic Compatibility 

Labeling 

Electrical safety issues ............................................................................................................................. Electrical Safety Testing 

Labeling 

Corrosion .................................................................................................................................................. Bench testing 

Improper deployment or inability to deploy .............................................................................................. Bench testing 

Animal testing 

Clinical evaluation 

Software validation 

Failure to prevent endograft migration or Type I endoleak ..................................................................... Bench testing 

Clinical evaluation 

Cadaver testing 


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8118 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Rules and Regulations 

FDA believes that the following 

special controls address the risks to 

health and provide reasonable assurance 

of the safety and effectiveness of the 

device: (1) The device should be 

demonstrated to be biocompatible; (2) 

sterility and shelf life testing should 

demonstrate the sterility of patientcontacting components and the shelflife of these components; (3) nonclinical and clinical performance testing 

should demonstrate substantial 

equivalence in safety and effectiveness, 

including durability, compatibility, 

migration resistance, corrosion 

resistance, and delivery and 

deployment; (4) non-clinical testing 

should evaluate the compatibility of the 

device in an magnetic resonance (MR) 

environment; (5) appropriate analysis 

and non-clinical testing should validate 

electromagnetic compatibility (EMC) 

and electrical safety; (6) the sale, 

distribution, and use of the device are 

restricted to prescription use in 

accordance with 21 CFR 801.109 

(§ 801.109); and (7) labeling must bear 

all information required for the safe and 

effective use of the device as outlined in 

§ 801.109(c), including a detailed 

summary of the non-clinical and 

clinical evaluations pertinent to use of 

the device; in addition to general 

controls, address the risks to health and 

provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on November 21, 2011, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding § 870.3460. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for an endovascular 

suturing system will need to comply 

with the special controls named in the 

regulation. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C 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, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. 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 endovascular suturing system 

they intend to market. 

II. 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. 

III. 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 

reclassification of this device from class 

III to class II will relieve manufacturers 

of the device of the cost of complying 

with the premarket approval 

requirements of section 515 of the FD&C 

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 $136 

million, using the most current (2010) 

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. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. (See 

21 U.S.C. 360(k); See Medtronic, Inc. v. 

Lohr, 518 U.S. 470 (1996); Riegel v. 

Medtronic, Inc., 552 U.S. 312 (2008)). 

The special controls established by this 

final rule create ‘‘requirements’’ to 

address each identified risk to health 

presented by these specific medical 

devices under 21 U.S.C. 360(k), even 

though product sponsors may have 

flexibility in how they meet those 

requirements (See Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–42 (9th Cir. 

1997)). 

V. 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. 

32501–3520). The collections of 

information in part 807 subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control no. 0910–0120; the 

collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control no. 0910– 

0485. 

VI. Reference 

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: Request for Evaluation of 

Automatic Class III Designation under 

§ 513(f)(2) of the Food, Drug, and Cosmetic 

Act from Aptus Endosystems, Inc., December 

10, 2010. 

List of Subjects in 21 CFR Part 870 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 


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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Rules and Regulations 8119 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 870 is 

amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2 Section 870.3460 is added to 

subpart D to read as follows: 

§ 870.3460 Endovascular Suturing System. 

(a) Identification. An endovascular 

suturing system is a medical device 

intended to provide fixation and sealing 

between an endovascular graft and the 

native artery. The system is comprised 

of the implant device and an 

endovascular delivery device used to 

implant the endovascular suture. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device should be 

demonstrated to be biocompatible; 

(2) Sterility and shelf life testing 

should demonstrate the sterility of 

patient-contacting components and the 

shelf-life of these components; 

(3) Non-clinical and clinical 

performance testing should demonstrate 

substantial equivalence in safety and 

effectiveness, including durability, 

compatibility, migration resistance, 

corrosion resistance, and delivery and 

deployment; 

(4) Non-clinical testing should 

evaluate the compatibility of the device 

in an magnetic resonance (MR) 

environment; 

(5) Appropriate analysis and nonclinical testing should validate 

electromagnetic compatibility (EMC) 

and electrical safety; 

(6) The sale, distribution, and use of 

the device are restricted to prescription 

use in accordance with 21 CFR 801.109 

of this chapter; and 

(7) Labeling must bear all information 

required for the safe and effective use of 

the device as outlined in § 801.109(c) of 

this chapter, including a detailed 

summary of the non-clinical and 

clinical evaluations pertinent to use of 

the device. 

Dated: February 9, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–3398 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice 7796] 

Visas: Issuance of Full Validity L Visas 

to Qualified Applicants 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: This rule permits the issuance 

of L visas with validity periods based on 

the visa reciprocity schedule; whereas 

the current rule limits L visas to the 

petition validity period, which is 

determined by the Department of 

Homeland Security. 

DATES: This rule is effective February 

14, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Lauren A. Prosnik, Legislation and 

Regulations Division, Visa Services, 

Department of State, 2401 E Street NW., 

Room L–603D, Washington, DC 20520– 

0106, (202) 663–1260. 

SUPPLEMENTARY INFORMATION: 

Why is the department promulgating 

this rule? 

Current Department regulations 

require that L visa duration be limited 

to the validity period of the petition, 

which, under Department of Homeland 

Security (DHS) regulations, cannot 

exceed three years. Petitioners may 

apply to U.S. Citizenship and 

Immigration Services (USCIS) for 

extension of petition validity in 

increments of up to two years, but the 

total period of stay may not exceed five 

years for aliens employed in a 

specialized knowledge capacity, or 

seven years for aliens employed in a 

managerial or executive capacity. The 

Department is changing this regulation 

to delink visa and petition validity 

periods, as currently required by 22 CFR 

41.54(c), ‘‘Validity of visa’’. As a result, 

L visa validity will be governed by 22 

CFR 41.112, which provides that, except 

as provided in paragraphs (c) and (d) of 

that section, a nonimmigrant visa shall 

have the validity prescribed in 

schedules provided to consular officers 

by the Department, which reflect the 

reciprocal treatment the applicant’s 

country accords U.S. nationals, U.S. 

permanent residents, or aliens granted 

refugee status in the United States. The 

change would assist beneficiaries of 

petitions for L status who are nationals 

of countries for which the reciprocity 

schedule prescribes visa validity for a 

longer period of time than the initial 

validity indicated in the petition 

approved by DHS and who have 

extended their L stay while in the 

United States. Subject to 22 CFR 

41.112(c), such individuals generally 

would not need to apply again for an L 

visa at a U.S. Embassy or Consulate 

overseas if they were to travel outside 

the United States during the period 

indicated in the applicable reciprocity 

schedule, as is currently required when 

petition validity has been extended. 

Under 8 CFR 214.2(l)(11), an alien may 

apply for admission in L status only 

while the individual or blanket petition 

is valid. 

Regulatory Findings 

Administrative Procedure Act 

This regulation involves a foreign 

affairs function of the United States and, 

therefore, in accordance with 5 U.S.C. 

553(a)(1), is not subject to the rule 

making procedures set forth at 5 U.S.C. 

553. 

Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

Because this final rule is exempt from 

notice and comment rulemaking under 

5 U.S.C. 553, it is exempt from the 

regulatory flexibility analysis 

requirements set forth at sections 603 

and 604 of the Regulatory Flexibility 

Act (5 U.S.C. 603 and 604). Nonetheless, 

consistent with section 605(b) of the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)), the Department certifies that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities. This regulates 

individual aliens applying for visas 

under INA § 101(A)(15)(L) and does not 

affect any small entities, as defined in 

5 U.S.C. 601(6). 

Unfunded Mandates Reform Act of 1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995, Public 

Law 104–4, 109 Stat. 48, 2 U.S.C. 1532, 

generally requires agencies to prepare a 

statement before proposing any rule that 

may result in an annual expenditure of 

$100 million or more by State, local, or 

tribal governments, or by the private 

sector. This rule will not result in any 

such expenditure, nor will it 

significantly or uniquely affect small 

governments. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule is not a major rule as 

defined by 5 U.S.C. 804, for purposes of 

congressional review of agency 

rulemaking under the Small Business 

Regulatory Enforcement Fairness Act of 

1996, Public Law 104–121. This rule 

will not result in an annual effect on the 

economy of $100 million or more; a 

major increase in costs or prices; or 

adverse effects on competition, 


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