Cardiovascular Devices; Reclassification of External Cardiac Compressor, 1162-1166 [2013-00085]

Download as PDF 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. 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. SUMMARY: 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: srobinson on DSK4SPTVN1PROD with DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. VerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 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). PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 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).) E:\FR\FM\08JAP1.SGM 08JAP1 srobinson on DSK4SPTVN1PROD with Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 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. VerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 1163 II. Regulatory History of the Device IV. Proposed Reclassification 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. 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. 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. PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 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 E:\FR\FM\08JAP1.SGM 08JAP1 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. srobinson on DSK4SPTVN1PROD with 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 VerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 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 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 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 E:\FR\FM\08JAP1.SGM 08JAP1 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Proposed Rules 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. srobinson on DSK4SPTVN1PROD with 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 VerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 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 1165 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: ■ 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. Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. XIII. Comments § 870.5200 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. (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 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 PO 00000 Medical devices. Frm 00012 Fmt 4702 Sfmt 4702 2. Section 870.5200 is revised to read as follows: ■ E:\FR\FM\08JAP1.SGM 08JAP1 External cardiac compressor. 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 Architectural and Transportation Barriers Compliance Board. ACTION: Notice of advisory committee meeting. AGENCY: 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 srobinson on DSK4SPTVN1PROD with SUMMARY: VerDate Mar<15>2010 16:21 Jan 07, 2013 Jkt 229001 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. 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. DATES: 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). SUPPLEMENTARY INFORMATION: PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 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 Federal Communications Commission. ACTION: Notice of proposed rulemaking. AGENCY: 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 SUMMARY: E:\FR\FM\08JAP1.SGM 08JAP1

Agencies

[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Proposed Rules]
[Pages 1162-1166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00085]


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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.

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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).)

[[Page 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

[[Page 1164]]

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 well-known. 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

[[Page 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

0
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.

0
2. Section 870.5200 is revised to read as follows:


Sec.  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

[[Page 1166]]

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 Sec.  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