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