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).) 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 1163 

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 (DC 

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

766 F.2d 592 (DC Cir.), cert. denied, 474 

U.S. 1062 (1985).) 

FDA relies upon ‘‘valid scientific 

evidence’’ in the classification process 

to determine the level of regulation 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 March 9, 1979 (44 FR 13424), FDA 

published a proposed rule for 

classification of external cardiac 

compressors as class III requiring 

premarket approval. The Cardiovascular 

Device Classification Panel and the 

Anesthesiology Device Classification 

Panel recommended class III because 

the device is life supporting and is 

potentially hazardous to life or health 

even when properly used, and the Panel 

believed that there was not sufficient 

information to develop a performance 

standard to provide a reasonable 

assurance of safety and effectiveness. No 

comments were received on the 

proposed rule and on February 5, 1980 

(45 FR 7966), a final rule was published 

for external cardiac compressors, 

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 

external cardiac compressor devices (52 

FR 17732 at 17737; 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 effectivness 

information on external cardiac 

compressors (74 FR 16214; April 9, 

2009). In response to that order, FDA 

received information from four 

manufacturers of external cardiac 

compressor devices. 

III. Device Description 

External cardiac compressors (ECCs), 

also known as chest compressors, assist 

in the act of CPR. The devices in this 

classification are divided into two types: 

(1) Devices that provide automatic chest 

compressions at a fixed compression 

rate and depth (automated external 

cardiac compressors), which are placed 

directly on the patient’s chest and are 

powered manually, pneumatically, or 

electrically and (2) devices that aid the 

emergency medical professional in 

delivering manual compressions at a 

compression depth and rate that are 

consistent with current guidelines (CPR 

Aids). These devices are placed beneath 

the hands of the emergency medical 

professional or in the vicinity of the 

cardiac arrest victim and provide audio 

and/or visual feedback to assist 

emergency personnel in following the 

recommended steps for CPR and 

maintaining the recommended rate and 

depth of compressions for the duration 

of CPR. 

IV. Proposed Reclassification 

FDA is proposing that the device 

subject to this proposed order be 

reclassified from class III to class II. 

FDA believes CPR Aid devices and 

automated external cardiac compressor 

devices when used as indicated can 

supplement the effective delivery of 

CPR. 

FDA believes that the identified 

special controls, in addition to general 

controls, would 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. 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 

ECCs. 

FDA has considered automated 

external cardiac compressor devices in 

accordance with the reserved criteria 

and has determined that the device 

should be subject to the premarket 

notification (510(k) of the FD&C Act) 

requirements as provided for under 

section 510(m) of the FD&C Act. 

However, the Agency does intend to 

exempt a CPR Aid device when it is a 

prescription use device and when the 

feedback provided to the rescuer is 

consistent with the current version of 

the American Heart Association (AHA) 

guidelines for CPR (Ref. 1) from 

premarket notification (section 510(k) of 

the FD&C Act) submission as provided 

for under section 510(m) of the FD&C 

Act. The AHA guidelines recommend 

that chest compressions be the highest 

priority and the initial action when 

starting CPR in the adult victim of 

sudden cardiac arrest. Chest 

compressions are an especially critical 

component of CPR because perfusion 

during CPR depends on these 

compressions. 

V. Risks to Health 

After considering available 

information, including the 

recommendations of the advisory 

committees (panels) for the 

classification of these devices, FDA has 

evaluated the risks to health associated 

with the use of external cardiac 

compressor devices and determined that 

the following risks to health are 


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1164 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

associated with use of the automated 

external cardiac compressor devices: 

• Tissue damage or bone breakage, or 

inadequate blood flow. Damage to the 

heart, other organs or tissues, can result 

from poor mechanical design, improper 

surface area of the plunger, improper 

vertical excursion of the plunger, 

improper force applied by the plunger, 

or improper energy transmission by the 

device. 

• Cardiac arrhythmias or electrical 

shock. Excessive electrical leakage 

current can disturb the normal 

electrophysiology of the heart, leading 

to the onset of cardiac arrhythmias. 

• Adverse skin reactions. Lack of 

biocompatibility in materials contacting 

skin may cause an adverse 

immunological or allergic reaction in a 

patient. 

FDA has evaluated the risks to health 

associated with the use of CPR Aid 

devices and determined that the 

following risks to health are associated 

with use of CPR Aid devices: 

• Suboptimal CPR delivery. 

Inaccurate rate or depth feedback from 

the device or inadequate labeling may 

result in suboptimal delivery of CPR. 

• Adverse skin reactions. Lack of 

biocompatibility in materials contacting 

skin may cause an adverse 

immunological or allergic reaction in a 

patient. 

VI. Summary of Reasons for 

Reclassification 

FDA believes that automated external 

cardiac compressor devices indicated 

for adjunctive use with manual CPR 

(e.g., during transport—to assure more 

consistent and continuous therapy; or 

prolonged CPR—to avoid/replace 

rescuer fatigue) and CPR Aid devices 

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. 

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 automated external 

cardiac compressors indicated for 

adjunctive use with manual CPR and 

CPR Aid devices into class II with 

special controls. 

Automated external cardiac 

compressors are tools used by 

emergency medical personnel to 

automate chest compressions during 

CPR. These devices are typically used in 

situations where extended CPR is 

required, such as during patient 

transport or when there are an 

inadequate number of trained personnel 

during extended CPR. The review of the 

available literature on mechanical 

versus manual chest compressions both 

by AHA (Ref. 1) and in a recent 

systematic literature review (Ref. 2) 

provided mixed results on whether 

mechanical compressions are as 

effective as manual chest compressions. 

However, it is well established that 

chest compressions are crucial to 

maintaining perfusion and that 

compressions of adequate rate and 

depth are necessary to increase the 

probability of survival in victims of 

sudden cardiac arrest (Ref. 1). As such, 

FDA believes that these devices, when 

indicated for use as an adjunct to 

manual CPR during patient transport or 

for use in situations where fatigue of or 

inaccessibility to emergency medical 

personnel may otherwise prevent 

adequate chest compressions, can be 

regulated as class II devices. These 

devices should not be used as a 

replacement for manual CPR. FDA 

believes that the special controls, 

including adequate labeling of the 

device for the appropriate use 

population, use conditions, and use by 

appropriately trained personnel, and 

performance testing of the device to 

ensure adequate chest compression rate 

and depth, adequately mitigate the risks. 

CPR Aid devices are used to remind 

emergency medical personnel of 

appropriate CPR steps and technique 

and to provide feedback on the rate and 

depth of compressions. AHA guidelines 

on CPR and emergency cardiovascular 

care (Ref. 1) conclude that ‘‘real-time 

CPR prompting and feedback 

technology such as visual and auditory 

prompting devices can improve the 

quality of CPR.’’ In addition, these 

devices have been reviewed by FDA for 

many years, and their risks are wellknown. Between January 2000 and June 

2012, FDA has not received any adverse 

event reports (medical device reports) 

associated with CPR Aid devices. FDA 

believes that the identified special 

controls, in addition to the general 

controls, provide reasonable assurance 

of safety and effectiveness. 

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 for automated external 

cardiac compressor devices: 

• Performance testing under 

simulated physiological conditions 

must demonstrate the reliability of the 

delivery of specific compression depth 

and rate over the intended duration and 

environment of use; 

• Labeling must include the clinical 

training for the safe use of this device 

and information on the patient 

population for which the device has 

been demonstrated to be effective; 

• For devices that incorporate 

electrical components, appropriate 

analysis and testing must validate 

electrical safety and electromagnetic 

compatibility; 

• For devices containing software, 

software verification, validation, and 

hazard analysis must be performed; and 

• Any elements of the device that 

may contact the patient must be 

demonstrated to be biocompatible; 

In addition, under 21 CFR 801.109, 

the sale, distribution, and use of the 

automated external cardiac compressor 

device are restricted to prescription use. 

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 for CPR Aid devices: 

• Performance testing under 

simulated physiological or use 

conditions must demonstrate the 

accuracy and reliability of the feedback 

to the user on specific compression rate 

and/or depth over the intended duration 

of use; 

• Labeling must include the clinical 

training, if needed, for the safe use of 

this device and information on the 

patient population for which the device 

has been demonstrated to be effective; 

• For devices that incorporate 

electrical components, appropriate 

analysis and testing must validate 

electrical safety and electromagnetic 

compatibility; 

• For devices containing software, 

software verification, validation, and 

hazard analysis must be performed; 

• Any elements of the device that 

may contact the patient must be 

demonstrated to be biocompatible; and 

• For over-the counter-devices, 

human factors testing and analysis must 

validate that the device design and 

labeling are sufficient for lay use. 

IX. Exemption From Premarket 

Notification Requirements 

FDA, on its own initiative, is also 

proposing to exempt CPR Aid devices 

that provide feedback consistent with 

the current AHA guidelines for CPR 

from premarket notification, subject to 

limitations. The AHA guidelines are 

intended to support emergency medical 

personnel with a series of sequential 

assessments and actions for 

resuscitation of the victim. The intent of 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 1165 

the AHA guideline is to provide 

recommendations on the most effective 

CPR practices, rather than specific 

instructions for using CPR Aid or other 

devices on a victim of sudden cardiac 

arrest. 

FDA may consider a number of factors 

in determining whether premarket 

notification is necessary to provide 

reasonable assurance of the safety and 

effectiveness of a class II device. These 

factors are discussed in the guidance the 

Agency issued on February 19, 1998, 

entitled ‘‘Procedures for Class II Device 

Exemptions From Premarket 

Notification, Guidance for Industry and 

CDRH Staff ’’ (Ref. 3). 

FDA believes that a CPR Aid, when it 

is a prescription use device that 

provides feedback compliant with the 

current AHA guidelines for CPR, is 

appropriate for exemption from 

premarket notification, subject to the 

limitations of exemptions identified in 

21 CFR 870.9, because the applicable 

special controls and general controls 

provide reasonable assurance of safety 

and effectiveness if device 

manufacturers follow the special 

controls requirements. 

FDA advises that exemption from the 

requirement of premarket notification 

for prescription CPR Aids does not 

mean that these devices would be 

exempt from any other statutory or 

regulatory requirements, unless such 

exemption is explicitly provided by 

order or regulation. Indeed, FDA’s 

proposal to exempt these devices from 

the requirement of premarket 

notification is based, in part, on the 

assurance of safety and effectiveness 

that other regulatory controls, such as 

current good manufacturing practice 

requirements (21 CFR part 820) and the 

identified special controls, provide. 

X. 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. 

XI. 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 

are approved under OMB control 

number 0910–0485. 

XII. 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. 

XIII. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments 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. 

XIV. 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 

all the Web site addresses in this 

reference section, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Berg R. A., R. Hemphill, B. S. Abella, 

et al., ‘‘2010 American Heart Association 

Guidelines for Cardiopulmonary 

Resuscitation and Emergency Cardiovascular 

Care Circulation,’’ vol. 122, issue 18, suppl. 

3, 2010, available at http:// 

circ.ahajournals.org/content/122/ 

18_suppl_3/S685.full.pdf+html. 

2. Brooks S. C., B. L. Bigham, and L. J. 

Morrison, ‘‘Mechanical Versus Manual Chest 

Compressions for Cardiac Arrest (Review),’’ 

The Cochrane Library, issue 1, 2011, 

available at http://onlinelibrary.wiley.com/ 

doi/10.1002/14651858.CD007260.pub2/pdf. 

3. FDA guidance, ‘‘Procedures for Class II 

Device Exemptions From Premarket 

Notification, Guidance for Industry and 

CDRH Staff,’’ 1998, available at http:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm080198.htm. 

List of Subjects in 21 CFR Part 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 part 870 be 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 870.5200 is revised to read 

as follows: 

§ 870.5200 External cardiac compressor. 

(a) Identification. An automated 

external cardiac compressor is an 

external device that is electrically, 

pneumatically, or manually powered 

and is used to compress the chest 

periodically in the region of the heart to 

provide blood flow during cardiac 

arrest. Automated external cardiac 

compressor devices are used as an 

adjunct to manual cardiopulmonary 

resuscitation (CPR) during patient 

transport or extended CPR. This also 

includes CPR Aid devices, which are 

external devices intended to provide 

audio and/or visual feedback to the 

rescuer regarding compression rate and/ 

or depth, to aid in the consistent 

application of manual CPR. 

(b) Classification. (1) Class II (special 

controls) for the automated external 

cardiac compressor device. The special 

controls for this device are: 

(i) Performance testing under 

simulated physiological conditions 

must demonstrate the reliability of the 

delivery of specific compression depth 

and rate over the intended duration of 

use; 

(ii) Labeling must include the clinical 

training for the safe use of this device 

and information on the patient 

population for which the device has 

been demonstrated to be effective; 

(iii) For devices that incorporate 

electrical components, appropriate 

analysis and testing must validate 

electrical safety and electromagnetic 

compatibility; 

(iv) For devices containing software, 

software verification, validation, and 

hazard analysis must be performed; and 

(v) Any elements of the device that 

may contact the patient must be 

demonstrated to be biocompatible. 

(2) Class II (special controls) for the 

CPR Aid device. The special controls for 

this device are: 

(i) Performance testing under 

simulated physiological conditions 

must demonstrate the accuracy and 

reliability of the feedback to the user on 

specific compression rate and/or depth 


srobinson on DSK4SPTVN1PROD with 
1166 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 

over the intended duration and 

environment of use; 

(ii) Labeling must include the clinical 

training, if needed, for the safe use of 

this device and information on the 

patient population for which the device 

has been demonstrated to be effective; 

(iii) For devices that incorporate 

electrical components, appropriate 

analysis and testing must validate 

electrical safety and electromagnetic 

compatibility; 

(iv) For devices containing software, 

software verification, validation, and 

hazard analysis must be performed; 

(v) Any elements of the device that 

may contact the patient device must be 

demonstrated to be biocompatible; and 

(vi) For over-the-counter devices, 

human factors testing and analysis must 

validate that the device design and 

labeling are sufficient for lay use. 

(c) Premarket notification. The CPR 

aid device is exempt from the premarket 

notification procedures in subpart E of 

part 807 of this chapter if it is a 

prescription use device that provides 

feedback to the rescuer consistent with 

the current American Heart Association 

guidelines for CPR and in compliance 

with the special controls under 

paragraph (b)(2) of this section, subject 

to the limitations of exemptions in 

§ 870.9. 

Dated: January 2, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00085 Filed 1–7–13; 8:45 am] 

BILLING CODE 4160–01–P 

ARCHITECTURAL AND 

TRANSPORTATION BARRIERS 

COMPLIANCE BOARD 

36 CFR Part 1195 

[Docket No. ATBCB–2012–0003] 

RIN 3014–AA40 

Medical Diagnostic Equipment 

Accessibility Standards Advisory 

Committee 

AGENCY: Architectural and 

Transportation Barriers Compliance 

Board. 

ACTION: Notice of advisory committee 

meeting. 

SUMMARY: The Medical Diagnostic 

Equipment Accessibility Standards 

Advisory Committee will hold its third 

meeting. On July 5, 2012, the 

Architectural and Transportation 

Barriers Compliance Board (Access 

Board) established the advisory 

committee to make recommendations to 

the Board on matters associated with 

comments received and responses to 

questions included in a previously 

published Notice of Proposed 

Rulemaking (NPRM) on Medical 

Diagnostic Equipment Accessibility 

Standards. 

DATES: The Committee will meet on 

January 22, 2013, from 10:00 a.m. to 

5:00 p.m. and on January 23, 2012, from 

9:00 a.m. to 2:30 p.m. 

ADDRESSES: The meeting will be held at 

the Access Board’s Conference Room, 

1331 F Street NW., Suite 800, 

Washington, DC 20004–1111. 

FOR FURTHER INFORMATION CONTACT: Rex 

Pace, Office of Technical and 

Information Services, Architectural and 

Transportation Barriers Compliance 

Board, 1331 F Street NW., Suite 1000, 

Washington, DC 20004–1111. 

Telephone number (202) 272–0023 

(Voice); (202) 272–0052 (TTY). 

Electronic mail address: pace@accessboard.gov. 

SUPPLEMENTARY INFORMATION: On July 5, 

2012, the Architectural and 

Transportation Barriers Compliance 

Board (Access Board) established an 

advisory committee to make 

recommendations to the Board on 

matters associated with comments 

received and responses to questions 

included in a previously published 

NPRM on Medical Diagnostic 

Equipment Accessibility Standards. See 

77 FR 6916 (February 9, 2012). The 

NPRM and information related to the 

proposed standards are available on the 

Access Board’s Web site at: http:// 

www.access-board.gov/medicalequipment.htm. 

The advisory committee will hold its 

third meeting on January 22 and 23, 

2013. The agenda includes the 

following: 

• Review of previous committee 

work; 

• Presentations by medical 

practitioners and clinicians on the use 

of medical diagnostic equipment in 

relation to transfer surfaces; 

• Continued discussion on 

subcommittees based on medical 

diagnostic equipment type; 

• Continued discussion on transfer 

surface height and size; 

• Review and discussion on transfer 

support location and configuration; 

• Consideration of issues proposed by 

committee members; and 

• Discussion of administrative issues. 

The preliminary meeting agenda, 

along with information about the 

committee, is available at the Access 

Board’s Web site (http://www.accessboard.gov/medical-equipment.htm). 

Committee meetings are open to the 

public and interested persons can attend 

the meetings and communicate their 

views. Members of the public will have 

opportunities to address the committee 

on issues of interest to them during 

public comment periods scheduled on 

each day of the meeting. 

The meetings will be accessible to 

persons with disabilities. An assistive 

listening system, computer assisted realtime transcription (CART), and sign 

language interpreters will be provided. 

Persons attending the meetings are 

requested to refrain from using perfume, 

cologne, and other fragrances for the 

comfort of other participants (see 

www.access-board.gov/about/policies/ 

fragrance.htm for more information). 

Also, persons wishing to provide 

handouts or other written information to 

the committee are requested to provide 

electronic formats to Rex Pace via email 

prior to the meetings so that alternate 

formats can be distributed to committee 

members. 

David M. Capozzi, 

Executive Director. 

[FR Doc. 2013–00071 Filed 1–7–13; 8:45 am] 

BILLING CODE 8150–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1 and 27 

[WT Docket No. 12–357; FCC 12–152] 

Service Rules for the Advanced 

Wireless Services in the H Block— 

Implementing Section 6401 of the 

Middle Class Tax Relief and Job 

Creation Act of 2012 Related to the 

1915–1920 MHz and 1995–2000 MHz 

Bands 

AGENCY: Federal Communications 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: In this document, the 

Commission proposes rules for the 

Advanced Wireless Services (AWS) H 

Block that would make available ten 

megahertz of spectrum for flexible use. 

The proposal would extend the widelydeployed Personal Communications 

Services (PCS) band, which is used by 

the four national providers as well as 

regional and rural providers to offer 

mobile service across the nation. The 

additional spectrum for mobile use will 

help ensure that the speed, capacity, 

and ubiquity of the nation’s wireless 

networks keeps pace with the 

skyrocketing demand for mobile service. 

DATES: Submit comments on or before 

February 6, 2013. Submit reply 


srobinson on DSK4SPTVN1PROD with