1158 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

(h) Inspect Each P/N 0322709 and P/N 

0322709–1 Inboard Aileron Hinge Bracket or 

Any Other Bracket Made From Magnesium 

for Cracks or Corrosion 

Within the next 100 hours time-in-service 

(TIS) after November 30, 2004 (the effective 

date retained from AD 2004–21–08, 

Amendment 39–13828 (69 FR 62396, October 

26, 2004)), and repetitively thereafter at 

intervals not to exceed 100 hours TIS until 

each bracket is replaced with aluminum, 

inspect each P/N 0322709 and P/N 0322709– 

1 inboard aileron hinge bracket or any other 

bracket made from magnesium for cracks or 

corrosion. 

(i) Replace Any Cracked or Corroded 

Inboard Aileron Hinge Bracket 

Before further flight after any inspection 

where any cracked or corroded bracket is 

found, replace any cracked or corroded 

inboard aileron hinge. 

(1) If replacement is with an FAAapproved bracket made from magnesium, do 

the 100-hour TIS interval repetitive 

inspections as required in paragraph (h) of 

this AD. 

(2) If replacement is with an FAAapproved bracket that is made from 

aluminum, then no further inspections are 

necessary. These can be Cessna parts or nonCessna parts. 

(j) Terminating Action for the Repetitive 

Inspections 

(1) As terminating action for the repetitive 

inspections, you may replace all inboard 

aileron hinge brackets with FAA-approved 

brackets that are made from aluminum (as 

specified in paragraph (i)(2) of this AD) 

regardless if any corrosion or crack is found. 

(2) You may do this replacement at any 

time, but you must replace any corroded or 

cracked bracket before further flight after the 

applicable inspection where any corrosion or 

crack is found. 

(k) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Wichita Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(3) All AMOCs approved for AD 2004–21– 

08 (69 FR 62396, October 26, 2004) are 

approved for this AD. 

(l) Related Information 

(1) For more information about this AD, 

contact Gary Park, Aerospace Engineer, 

Wichita ACO, FAA, 1801 Airport Road, 

Wichita, KS 67209; phone: (316) 946–4123; 

fax: (316) 946–4107; email: 

gary.park@faa.gov. 

(2) For service information identified in 

this AD, contact Cessna Aircraft Company, 

Customer Service, P.O. Box 7706, Wichita, 

KS 67277; telephone: (316) 517–5800; fax: 

(316) 517–7271; email: 

customercare@cessna.textron.com; Internet: 

http://www.cessnasupport.com. You may 

review copies of the referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, MO 

64106. For information on the availability of 

this material at the FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on 

December 31, 2012. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2013–00069 Filed 1–7–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 868 and 870 

[Docket No. FDA–2012–N–1174] 

Anesthesiology Devices; 

Reclassification of Membrane Lung for 

Long-Term Pulmonary Support; 

Redesignation as Extracorporeal 

Circuit and Accessories for Long-Term 

Pulmonary/Cardiac Support 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: On its own initiative, based 

on new information, the Food and Drug 

Administration (FDA) is proposing to 

reclassify membrane lung devices for 

long-term pulmonary support, a 

preamendments class III device, into 

class II (special controls) for conditions 

where imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. A membrane lung for 

long-term pulmonary support refers to 

the oxygenator component of an 

extracorporeal circuit used during longterm procedures, commonly referred to 

as extracorporeal membrane 

oxygenation (ECMO). Because circuit 

components used with the oxygenator 

are to be subject to the same regulatory 

controls, all of the device components 

used in an ECMO procedure are being 

considered in the scope of this proposed 

order, and the title and identification of 

the regulation will be revised 

accordingly to include extracorporeal 

circuit and accessories for long-term 

pulmonary/cardiac support. 

DATES: Submit either electronic or 

written comments on this proposed 

order by April 8, 2013. See section XI 

of this document for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

1174, 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–1174 for this 

order. 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: 

Angela Krueger, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1666, Silver Spring, 

MD 20993, 301–796–6380, 

angela.krueger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The FD&C Act, 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 Medical Devices Technical 

Corrections Act of 2004 (Pub. L. 108– 


srobinson on DSK4SPTVN1PROD with 
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214), the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), and Food and Drug Administration 

Safety and Innovation Act (FDASIA) 

(Pub. L. 112–144) 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, reflecting 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, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA process. Those 

devices remain in class III and require 

premarket approval unless, and until, 

the device is 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, 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 (21 CFR part 

807). 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA (126 Stat. 

1056) amended section 513(e) of the 

FD&C Act, changing the process for 

reclassifying a device from rulemaking 

to an administrative order. 

Section 513(e) of the FD&C Act 

governs reclassification of 

preamendments devices. This section 

provides that FDA may, by 

administrative order, reclassify a device 

(in a proceeding that parallels the initial 

classification proceeding) based upon 

‘‘new information.’’ FDA can initiate a 

reclassification under section 513(e) of 

the FD&C Act or an interested person 

may petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the FD&C Act, includes information 

developed as a result of a reevaluation 

of the data before the Agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time. 

(See, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(D.C. Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970); Bell v. 

Goddard, 366 F.2d 177 (7th Cir. 1966).) 

Reevaluation of the data previously 

before the Agency is an appropriate 

basis for subsequent regulatory action 

where the reevaluation is made in light 

of newly available regulatory authority 

(see Bell v. Goddard, supra, 366 F.2d at 

181; Ethicon, Inc. v. FDA, 762 F.Supp. 

382, 389–391 (D.D.C. 1991)) or in light 

of changes in ‘‘medical science.’’ (See 

Upjohn v. Finch, supra, 422 F.2d at 

951.) Whether data before the Agency 

are past or new data, the ‘‘new 

information’’ to support reclassification 

under section 513(e) must be ‘‘valid 

scientific evidence,’’ as defined in 

section 513(a)(3) of the FD&C Act and 

21 CFR 860.7(c)(2). (See, e.g., General 

Medical Co. v. FDA, 770 F.2d 214 (D.C. 

Cir. 1985); Contact Lens Assoc. v. FDA, 

766 F.2d 592 (D.C. Cir.), cert. denied, 

474 U.S. 1062 (1985).) 

FDA relies upon ‘‘valid scientific 

evidence’’ in the classification process 

to determine the level of order for 

devices. To be considered in the 

reclassification process, the valid 

scientific evidence upon which the 

Agency relies must be publicly 

available. Publicly available information 

excludes trade secret and/or 

confidential commercial information, 

e.g., the contents of a pending premarket 

approval application (PMA). (See 

section 520(c) of the FD&C Act (21 

U.S.C. 360j(c)).) Section 520(h)(4) of the 

FD&C Act, added by FDAMA, provides 

that FDA may use, for reclassification of 

a device, certain information in a PMA 

6 years after the application has been 

approved. This includes information 

from clinical and preclinical tests or 

studies that demonstrate the safety or 

effectiveness of the device but does not 

include descriptions of methods of 

manufacture or product composition 

and other trade secrets. 

Section 513(e)(1) of the FD&C Act sets 

forth the process for issuing a final 

order. Specifically, prior to the issuance 

of a final order reclassifying a device, 

the following must occur: (1) 

Publication of a proposed order in the 

Federal Register; (2) a meeting of a 

device classification panel described in 

section 513(b) of the FD&C Act; and (3) 

consideration of comments from all 

affected stakeholders, including 

patients, payors, and providers. 

FDAMA added section 510(m) to the 

FD&C Act. 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. 

II. Regulatory History of the Device 

On November 2, 1979 (44 FR 63387), 

FDA published a proposed rule for 

classification of membrane lungs for 

long-term pulmonary support as class III 

requiring premarket approval. The 

Anesthesiology Device Classification 

Panel recommended class III because 

the device is life sustaining and life 

supporting and sufficient information 

did not exist to determine the adequacy 

of general controls or to establish 

standards to provide a reasonable 

assurance of the safety and effectiveness 

of the device. 

No comments were received on the 

proposed rule and on July 16, 1982 (47 

FR 31130), a final rule was published 

for membrane lungs for long-term 

pulmonary support, classifying these 

devices as class III. In 1987, FDA 

published a final rule amending the 

codified language for this device to 

clarify that no effective date had been 

established for the requirement for 

premarket approval for membrane lungs 

for long-term pulmonary support 

devices (52 FR 17732 at 17735; May 11, 

1987). In 2009, FDA published an order 

under sections 515(i) and 519 of the 

FD&C Act (21 U.S.C. 360e and 360i) for 

the submission of safety and 

effectiveness information on a 

membrane lung for long-term 

pulmonary support (74 FR 16214; April 

9, 2009). In response to that order, FDA 

received information from one device 

manufacturer. 

III. Device Description 

A membrane lung for long-term 

pulmonary support refers to the 

oxygenator component of an 

extracorporeal circuit used during longterm procedures, commonly referred to 

as an ECMO. An ECMO procedure 

provides assisted extracorporeal 

circulation and physiologic gas 

exchange of a patient’s blood when an 

acute (reversible) condition prevents the 

patient’s own body from providing the 

physiologic gas exchange needed to 

sustain life. The circuit is comprised of 

multiple device types, including, but 


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1160 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

not limited to, an oxygenator, blood 

pump, cannulae, heat exchanger, tubing, 

filters, monitors/detectors, and other 

accessories; the circuit components and 

configuration (e.g., arteriovenous, venovenous) may differ based on the needs 

of the individual patient or the 

condition being treated. ECMO is 

intended for patients with acute 

reversible respiratory or cardiac failure, 

unresponsive to optimal ventilation 

and/or pharmacologic management. 

Because circuit components used 

with the oxygenator can be 

appropriately regulated using the same 

set of regulatory controls, all of the 

device components used in an ECMO 

procedure are being considered in the 

scope of this proposed order as an 

extracorporeal circuit and accessories 

for long-term pulmonary/cardiac 

support. 

IV. Proposed Reclassification 

FDA is proposing that the device 

subject to this proposed order be 

reclassified from class III to class II. 

FDA is further proposing to revise the 

title and identification of the regulation 

to reflect all device components used in 

ECMO. In addition, FDA is proposing to 

remove this regulation from 21 CFR part 

868, Anesthesiology Devices, and add 

the revised version to 21 CFR part 870, 

Cardiovascular Devices, to better align 

this device type with other similar types 

of cardiovascular devices and align the 

review responsibilities for this device 

type. FDA believes that these devices 

can be utilized to provide assisted 

extracorporeal circulation and 

physiologic gas exchange of a patient’s 

blood when an acute (reversible) 

condition prevents the patient’s own 

body from providing the physiologic gas 

exchange needed to sustain life in 

conditions where imminent death is 

threatened by cardiopulmonary failure 

in neonates and infants or where 

cardiopulmonary failure results in the 

inability to separate from 

cardiopulmonary bypass following 

cardiac surgery. 

FDA believes that the identified 

special controls, in addition to general 

controls, are necessary to provide 

reasonable assurance of safety and 

effectiveness. Therefore, in accordance 

with sections 513(e) and 515(i) of the 

FD&C Act and 21 CFR 860.130, based on 

new information with respect to the 

devices, FDA, on its own initiative, is 

proposing to reclassify this 

preamendments class III device into 

class II. The Agency has identified 

special controls under section 513(a) of 

the FD&C Act that would provide 

reasonable assurance of their safety and 

effectiveness. The new information 

includes the history of use of the circuit 

components, publicly available safety 

and effectiveness information (as 

described in Section VII of this 

document) and the relatively low 

incidence of adverse events, as 

discussed in the recommendations for 

reclassification from the device industry 

(available in docket FDA–2009–M–0101 

at http://www.regulations.gov). FDA 

believes that this information is 

sufficient to demonstrate that the 

proposed special controls can 

effectively mitigate the risks to health 

identified in section V of this document 

and that these special controls, in 

addition to the general controls, will 

provide a reasonable assurance of safety 

and effectiveness for ECMO devices. 

FDA has considered membrane lung 

devices for long-term pulmonary 

support in accordance with the reserved 

criteria and decided that the device does 

require premarket notification. The 

Agency does not intend to exempt this 

proposed class II device from premarket 

notification (510(k)) submission as 

provided for under section 510(m) of the 

FD&C Act. 

V. Risks to Health 

After considering available 

information, including the 

recommendations of the advisory 

committee (panel) for the classification 

of these devices along with information 

submitted in response to the 515(i) 

order and any additional information 

that FDA has encountered, FDA has 

evaluated the risks to health associated 

with the use of extracorporeal circuits 

and accessories for long-term 

pulmonary/cardiac support and 

determined that the following risks to 

health are associated with its use: 

• Thrombocytopenia. Blood platelets 

important to the clotting cascade may be 

damaged by use of the device, resulting 

in a tendency toward increased 

bleeding. 

• Hemolysis. Red blood cells may be 

damaged by mechanical, material, or 

surface features of the extracorporeal 

circuit. 

• Thrombosis/thromboembolism. 

Blood clots may form within the 

extracorporeal circuit due to inadequate 

blood flow. 

• Hemorrhage. To keep blood from 

clotting in the extracorporeal circuit, 

anticoagulants are generally used and 

may cause increased bleeding during 

the procedure. 

• Hemodilution. Dilution of the 

patient’s blood may be caused by the 

priming of the ECMO circuit. 

• Inadequate gas exchange. 

Mechanical failure of the circuit 

components may result in inadequate 

gas exchange. 

• Loss of mechanical integrity. 

Weakness in the connections or 

construction of the circuit components 

could lead to leaks in the extracorporeal 

circuit. 

• Gas embolism. Air may be 

introduced into the extracorporeal 

circuit and result in a gas embolism. 

• Adverse tissue reaction. The 

patient-contacting materials of the 

device may cause an adverse 

immunological or allergic reaction in a 

patient if the materials are not 

biocompatible. 

• Infection. Defects in the design or 

construction of the device preventing 

adequate cleaning and/or sterilization 

may allow pathogenic organisms to be 

introduced and may result in infection. 

• Mechanical injury to access vessels. 

Mechanical injury to vessels may be 

caused acutely during access, or over 

time due to the long-term duration of 

use. 

VI. Summary of Reasons for 

Reclassification 

FDA believes that extracorporeal 

circuits and accessories for long-term 

pulmonary/cardiac support should be 

reclassified into class II because special 

controls, in addition to general controls, 

can be established to provide reasonable 

assurance of the safety and effectiveness 

of the device. In addition, there is now 

adequate effectiveness information 

sufficient to establish special controls to 

provide such assurance for conditions 

where imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. 

FDA is proposing to rename this 

device to ‘‘Extracorporeal circuit and 

accessories for long-term pulmonary/ 

cardiac support’’; the current 

classification regulation for this device 

is referred to as ‘‘membrane lung for 

long-term pulmonary support.’’ For 

clarity, the new title for this proposed 

order will be removed from 21 CFR part 

868 and redesignated to 21 CFR part 

870. Section 870.4100 will be added to 

reflect all device components used in 

ECMO. 

VII. Summary of Data Upon Which the 

Reclassification Is Based 

Since the time of the Panel 

recommendation, sufficient evidence 

has been developed to support a 

reclassification of extracorporeal 

circuits and accessories for long-term 

pulmonary/cardiac support to class II 

with special controls for conditions 


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Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 1161 

where imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. FDA is familiar with 

the risks associated with the use of the 

components of the extracorporeal circuit 

because the same components are used 

for short-term use (durations less than 6 

hours) for cardiopulmonary bypass. In 

addition, the Extracorporeal Life 

Support Organization registry data (Ref. 

1), which provides information on over 

28,000 ECMO procedures performed 

since 1987, and reviews of institutional 

experience (Ref. 2) demonstrate a 

favorable benefit-risk profile for 

extracorporeal circuits and accessories 

when used for conditions where 

imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. 

VIII. Proposed Special Controls 

FDA believes that the following 

special controls, in addition to general 

controls, are sufficient to mitigate the 

risks to health described in section V of 

this document: 

• The design characteristics of the 

device must ensure that the geometry 

and design parameters are consistent 

with the intended use; 

• The device must be demonstrated to 

be biocompatible; 

• Sterility and shelf life testing must 

demonstrate the sterility of patientcontacting components and the shelflife of these components; 

• Nonclinical performance evaluation 

of the device must demonstrate a 

reasonable assurance of safety and 

effectiveness for mechanical integrity, 

durability, and reliability; 

• In-vivo evaluation of the device 

must demonstrate device performance; 

and 

• Labeling must include a detailed 

summary of the nonclinical and clinical 

evaluations pertinent to use of the 

device and adequate instructions with 

respect to anticoagulation, circuit set 

up, and maintenance during a 

procedure. 

In addition, under 21 CFR 801.109, 

the sale, distribution, and use of this 

device are restricted to prescription use. 

IX. 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. 

X. Paperwork Reduction Act of 1995 

This proposed order refers to 

previously approved collections of 

information found in 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 812 are 

approved under OMB control number 

0910–0078; the collections of 

information in part 807, subpart E, are 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 814, subpart 

B, are approved under OMB control 

number 0910–0231; and the collections 

of information under 21 CFR part 801 

have are under OMB control number 

0910–0485. 

XI. Proposed Effective Date 

FDA is proposing that any final order 

based on this proposal become effective 

30 days after date of publication of the 

final order in the Federal Register. 

XII. Comments 

Interested persons may submit either 

electronic comments to http:// 

www.regulations.gov or written 

comments regarding this document to 

the Division of Dockets Management 

(see ADDRESSES). 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, and will be 

posted to the docket at http:// 

www.regulations.gov. 

XIII. 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. 

1. Fleming, G. M., J. G. Gurney, J. E. 

Donahue, et al., ‘‘Mechanical Component 

Failures in 28,171 Neonatal and Pediatric 

Extracorporeal Membrane Oxygenation 

Courses From 1987 to 2006,’’ Pediatric 

Critical Care Medicine Journal, vol. 10, pp. 

439–444, July 2009. 

2. Cook, L. N., ‘‘Update on Extracorporeal 

Membrane Oxygenation,’’ Paediatric 

Respiratory Reviews, vol. 5, suppl. A, pp. 

S329–S337, 2004. 

List of Subjects in 21 CFR Parts 868 and 

870 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 868 and 870 be amended 

as follows: 

PART 868—ANESTHESIOLOGY 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 868 continues to read as follows: 

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

360j, 371. 

§ 868.5610 [Removed] 

■ 2. Remove § 868.5610. 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 3. The authority citation for 21 CFR 

part 870 continues to read as follows: 

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

360j, 371. 

■ 4. Add § 870.4100 to subpart E to read 

as follows: 

§ 870.4100 Extracorporeal circuit and 

accessories for long-term pulmonary/ 

cardiac support. 

(a) Identification. An extracorporeal 

circuit and accessories for long-term 

pulmonary/cardiac support (>6 hours) is 

a system of devices that provides 

assisted extracorporeal circulation and 

physiologic gas exchange of the 

patient’s blood in conditions where 

imminent death is threatened by 

cardiopulmonary failure in neonates 

and infants or where cardiopulmonary 

failure results in the inability to separate 

from cardiopulmonary bypass following 

cardiac surgery. An acute reversible or 

treatable cause of respiratory and/or 

cardiac failure should be evident, and 

the subject should demonstrate 

unresponsiveness to maximum medical 

or ventilation therapy. The main 

components of the system include the 

console (hardware), software, and 

disposables, including but not limited 

to, an oxygenator, blood pump, heat 

exchanger, cannulae, tubing, filters, and 

other accessories (e.g., monitors, 

detectors, sensors, connectors). 

(b) Class II (special controls). The 

special controls for this device are: 

(1) The design characteristics of the 

device must ensure that the geometry 

and design parameters are consistent 

with the intended use; 

(2) The device must be demonstrated 

to be biocompatible; 

(3) Sterility and shelf life testing must 

demonstrate the sterility of patientVerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM 08JAP1

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1162 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

contacting components and the shelflife of these components; 

(4) Non-clinical performance 

evaluation of the device must provide a 

reasonable assurance of safety and 

effectiveness for mechanical integrity, 

durability, and reliability; 

(5) In-vivo evaluation of the device 

must demonstrate device performance; 

and 

(6) Labeling must include a detailed 

summary of the nonclinical and clinical 

evaluations pertinent to use of the 

device and adequate instructions with 

respect to anticoagulation, circuit set 

up, and maintenance during a 

procedure. 

Dated: January 2, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00086 Filed 1–7–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2012–N–1173] 

Cardiovascular Devices; 

Reclassification of External Cardiac 

Compressor 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify the external cardiac 

compressor, including cardiopulmonary 

resuscitation (CPR) aids, from class III 

devices into class II (special controls). 

FDA is proposing this reclassification 

on its own initiative based on new 

information. FDA is taking this action 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), as 

amended. 

DATES: Submit either electronic or 

written comments on this proposed 

order by April 8, 2013. See section XII 

of this document for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

1173, 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–1173 for this 

order. 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: 

Melissa Burns, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1646, Silver Spring, 

MD 20993, 301–796–5616, 

melissa.burns@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The FD&C Act, 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 Medical Devices Technical 

Corrections Act of 2004 (Pub. L. 108– 

214), the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), and the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144), 

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, reflecting 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, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA process. Those 

devices remain in class III and require 

premarket approval unless, and until, 

the device is 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, 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 (21 CFR part 

807). 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA (126 Stat. 

1056) amended section 513(e) of the 

FD&C Act, changing the process for 

reclassifying a device from rulemaking 

to an administrative order. 

Section 513(e) of the FD&C Act 

governs reclassification of 

preamendments devices. This section 

provides that FDA may, by 

administrative order, reclassify a device 

(in a proceeding that parallels the initial 

classification proceeding) based upon 

‘‘new information.’’ FDA can initiate a 

reclassification under section 513(e) of 

the FD&C Act or an interested person 

may petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the FD&C Act, includes information 

developed as a result of a reevaluation 

of the data before the Agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time. 

(See, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(DC Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970); Bell v. 

Goddard, 366 F.2d 177 (7th Cir. 1966).) 


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