[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Proposed Rules]
[Pages 16252-16265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 860

[Docket No. FDA-2013-N-1529]


Medical Device Classification Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing classification and reclassification of 
medical devices to conform to the

[[Page 16253]]

applicable provisions in the Food and Drug Administration Safety and 
Innovation Act (FDASIA). FDA is also proposing changes unrelated to the 
new FDASIA requirements to update its regulations governing 
classification and reclassification of medical devices. FDA is taking 
this action to codify the procedures and criteria that apply to 
classification and reclassification of medical devices and to provide 
for classification of devices in the lowest regulatory class consistent 
with the public health and the statutory scheme for device regulation.

DATES: Submit either electronic or written comments on the proposed 
rule by June 23, 2014. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 (the PRA) by April 24, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1529 by any of the following methods, except that comments on 
information collection issues under the Paperwork Reduction Act of 1995 
must be submitted to the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB) (see the ``Paperwork Reduction 
Act of 1995'' section of this document).

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 ways:
     Mail/Hand delivery/Courier (for paper 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-2013-N-1529 for this rulemaking. 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: Marjorie Shulman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993, 301-796-
6572; or Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
II. Legal Authority
III. Proposed Revisions
    A. Proposed Amendments to 21 CFR 860.3--Definitions
    B. Proposed Amendments to 21 CFR 860.7--Determination of Safety 
and Effectiveness
    C. Proposed Amendments to 21 CFR 860.84--Classification 
Procedures for ``Preamendments Devices''
    D. Proposed New 21 CFR 860.90--Consultation With Panels
    E. Proposed Amendments to 21 CFR 860.93--Classification of 
Implantable Devices and Devices Intended for a Use in Supporting or 
Sustaining Human Life
    F. Proposed Amendments to 21 CFR 8680.95--Exemptions From 
Sections 510, 519, and 520(f) of the FD&C Act
    G. Proposed Amendments to 21 CFR 860.120--General
    H. Proposed Amendments to 21 CFR 860.123--Reclassification 
Petition: Content and Form
    I. Proposed Amendments to 21 CFR 860.125--Consultation With 
Panels
    J. Proposed Amendments to 21 CFR 860.130--General Procedures 
Under Section 513(e) of the FD&C Act
    K. Proposed Amendments to 21 CFR 860.132--Procedures When the 
Commissioner Initiates a Performance Standard or Premarket Approval 
Proceeding Under Sections 514(b) or 515(b) of the FD&C Act
    L. Proposed Addition of 21 CFR 860.133--Procedures When the 
Commissioner Initiates a Proceeding to Require Premarket Approval 
Under 515(b) of the FD&C Act
    M. Proposed Amendments to 21 CFR 860.134--Procedures for 
``Postamendment Devices'' Under Section 513(f)(3) of the FD&C Act 
and Reclassification of Certain Devices
    N. Proposed Amendments to 21 CFR 860.136--Procedures for 
Transitional Products Under Section 520(l) of the FD&C Act
IV. Environmental Impact
V. Analysis of Impacts
    A. Introduction
    B. Summary
VI. Federalism
VII. Paperwork Reduction Act of 1995
VIII. Proposed Effective Date
IX. Comments


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is proposing to revise the regulations in part 860 (21 CFR part 
860) to conform to recent changes made in FDASIA to sections 513(e) and 
515(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 
U.S.C. 360c(e) and 360e(b)), which became effective on July 9, 2012. 
These provisions established processes for reclassification of devices 
by administrative order instead of by regulation. FDA also proposes to 
update other reclassification provisions and to clarify the meaning of 
certain terms related to device classification and reclassification.

II. Legal Authority

    The FD&C Act (21 U.S.C. 301 et seq.) establishes a comprehensive 
system for the regulation of medical devices intended for human use. 
Section 513 of the FD&C Act established the following three categories 
(classes) of devices, reflecting the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness: class I 
(general controls), class II (special controls), and class III 
(premarket approval). For simplicity, FDA will refer to ``reasonable 
assurance of safety and effectiveness,'' the basic concept of device 
regulation, as ``RASE.'' Under section 513(d) of the FD&C Act, devices 
that were in commercial distribution before the enactment of the 1976 
amendments in 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.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order published in the Federal Register, reclassify a 
device 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 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 Dep't. of Health, 
Educ., & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. 
Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th 
Cir. 1966).)

[[Page 16254]]

    Section 608 of FDASIA amends section 513(e) of the FD&C Act and 
changes the procedure to reclassify a device under section 513(e). 
Under the new procedures, when FDA reclassifies devices under section 
513(e), it must do so through administrative order. Prior to the 
publication of a final order, FDA must also publish a proposed order in 
the Federal Register and consider any comments submitted on the 
proposed order. FDA must, in addition, hold a device classification 
panel meeting (21 U.S.C. 360c(b)). The panel meeting must occur before 
the final order is published, and may occur either before or after the 
proposed order is published. The proposed order must include the 
following: (1) A substantive summary of valid scientific evidence, 
including the public health benefits and risks of the device, (2) when 
reclassifying from class II to class III, an explanation that general 
and special controls are insufficient to reasonably assure safety and 
effectiveness, and (3) when reclassifying from class III to class II, 
an explanation that general and special controls are sufficient to 
reasonably assure safety and effectiveness.
    Section 608 of FDASIA also amends section 515(b) of the FD&C Act. 
Under section 515(b) of the FD&C Act as amended, preamendments devices 
that have been classified into class III and devices found 
substantially equivalent by means of premarket notification (510(k)) 
procedures to such preamendments devices or to devices within that 
generic device type may be marketed without submission of a premarket 
approval application (PMA) until FDA issues a final order requiring 
premarket approval. The process to require approval of a PMA for a 
preamendments class III device requires that FDA publish a proposed 
order in the Federal Register, hold an advisory committee meeting, and 
consider comments on the proposed order.
    Under section 515(b)(2) of the FD&C Act as amended, a proposed 
order to support the call for PMAs must: (1) Contain proposed findings 
with respect to the degree of risk of illness or injury designed to be 
eliminated or reduced by requiring the device to have an approved PMA 
(or a declared completed product development protocol (PDP) under 
section 515(f)) and the benefit to the public from the use of the 
device; (2) provide an opportunity for the submission of comments on 
the proposed order and the proposed findings; and (3) provide an 
opportunity to request a change in the classification of the device 
based on new information relevant to the classification of the device. 
After consideration of comments on the proposed order and findings, FDA 
must issue: (1) An administrative order requiring approval of a PMA and 
publish in the Federal Register findings with respect to the degree of 
risk of illness or injury designed to be eliminated or reduced by 
requiring the device to have an approved PMA or a declared completed 
PDP and the benefit to the public from the use of the device or (2) 
publish in the Federal Register a notice terminating the process to 
require approval of a PMA together with reasons for such termination, 
and initiate reclassification under section 513(e) of the FD&C Act.
    Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a 
preamendments class III device may be commercially distributed without 
a PMA or a notice of completion of a PDP until 90 days after FDA issues 
a final order requiring premarket approval for the device, or 30 months 
after final classification of the device under section 513 of the FD&C 
Act, whichever is later.
    FDA refers to devices that were not in commercial distribution 
before May 28, 1976, as ``postamendments devices.'' These devices are 
classified automatically under section 513(f) of the FD&C Act into 
class III without any FDA rulemaking process. Those devices remain in 
class III and require the filing of a PMA, unless and until: (1) FDA 
reclassifies the device into class I or II; (2) FDA issues an order 
classifying the device into class I or II under section 513(f)(2) of 
the FD&C Act; or (3) FDA issues an order finding the device to be 
substantially equivalent, under section 513(i) of the FD&C Act, to a 
predicate device that does not require the filing of a PMA. FDA 
determines whether new devices are substantially equivalent to 
previously cleared devices by means of premarket notification 
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 
CFR part 807.
    Section 513(f)(3) of the FD&C Act provides for reclassification of 
postamendments devices. Under this section, FDA may initiate, or the 
manufacturer or importer of a device may petition for the 
reclassification of a device classified into class III by operation of 
law under section 513(f)(1) of the FD&C Act.
    Reclassification of transitional devices is governed by section 
510(l)(2) of the FD&C Act. Under section 520(l)(2) of the FD&C Act (21 
U.S.C. 360j(l)(2)), FDA may initiate, or the manufacturer or importer 
of a device may petition for the reclassification of a device 
classified into class III by operation of law under section 520(l)(1). 
The 1976 amendments broadened the definition of ``device'' in section 
201(h) of the FD&C Act (21 U.S.C. 321(h)) to include certain articles 
that were once regulated as drugs. Under the 1976 amendments, Congress 
classified all those devices previously regulated as new drugs into 
class III (generally referred to as transitional devices). Congress 
amended section 520(l) of the FD&C Act to direct FDA to collect certain 
safety and effectiveness information from the manufacturers of 
transitional devices still remaining in class III to determine whether 
the devices should be reclassified into class II (special controls and 
general controls) or class I (general controls).
    Although combination products retain the regulatory identities of 
their constituent parts, the FD&C Act also recognizes combination 
products as a category of products that are distinct from products that 
are solely drugs, devices, or biological products, and that could be 
subject to specialized regulatory controls. See, e.g., section 
503(g)(4)(A) of the FD&C Act (21 U.S.C. 353(g)(4)(A)) and section 
563(a) of the FD&C Act (21 U.S.C. 360bbb-2(a)).
    In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) 
provides authority to issue regulations for the efficient enforcement 
of the FD&C Act. This includes the authority to develop regulations to 
ensure sufficient and appropriate ongoing assessment of the risks 
associated with devices and combination products.

III. Proposed Revisions

    FDASIA changed the procedures for reclassification of devices under 
section 513(e) of the FD&C Act, and for requiring PMAs for 
preamendments class III devices from notice and comment rulemaking 
under section 553 of the Administrative Procedure Act to an 
administrative order process. FDA is proposing these revisions to 
update its regulations to reflect these and other changes, and to 
ensure classification of devices in the lowest regulatory class 
consistent with the protection of the public health and the statutory 
scheme for device regulation.

A. Proposed Amendments to 21 CFR 860.3--Definitions

    This section provides the key definitions for part 860. FDA 
proposes to amend Sec.  860.3 to remove the paragraph designations and 
to list the definitions alphabetically. This proposed amendment would 
simplify adding any new definitions to this part. FDA is also proposing 
to change the term from ``life-supporting or life-sustaining device'' 
to the term ``supporting or sustaining human life'' to conform to the 
language of section 513 of the FD&C Act.

[[Page 16255]]

1. Definitions of Class I, II, and III
    FDA proposes to amend the definitions of class I, class II, and 
class III by revising the definitions to reflect a key principle 
underlying device classification, namely, that a reasonable assurance 
of safety and effectiveness is necessary for all three device classes; 
however, the level of regulation necessary to provide such assurance 
should be closely tailored to the risk presented by a type of device. 
Explanatory language about general and special controls has been 
removed from the definitions of class I and II, respectively, to avoid 
repetition with the new proposed definitions for the terms ``general 
controls'' and ``special controls''. Other minor changes are intended 
to improve the clarity and structure of these definitions.
    FDA is also proposing changes to the definition of class III to 
provide greater clarity regarding which devices fall within this class, 
and to improve transparency and predictability in device classification 
and reclassification decisions. Section 513(a)(1)(C) of the FD&C Act 
provides a definition for class III devices.
    An important aspect of this definition is that FDA must first 
determine that a device falls into one of the three categories that 
make the device potentially high risk to be eligible to be classified 
by FDA in class III because the FD&C Act explicitly reserves class III 
to devices that are intended for use in supporting or sustaining human 
life, of substantial importance in preventing impairment of health, or 
that present a potential unreasonable risk of illness or injury. The 
proposed definition retains this concept, reserving class III for 
devices that present heightened potential risks because they fall into 
one of three statutory categories. As a shorthand, this preamble will 
refer to devices described by section 513(a)(1)(C)(ii) of the FD&C Act 
as potentially high risk devices, although in some cases, such devices 
may be known to be high risk. Importantly, the proposed definition of 
class III refers to the initial statutory classification of 
postamendment (21 U.S.C. 360c(f)) and transitional devices (21 U.S.C. 
360j(l)(1)) to make clear that such devices are placed into class III 
automatically, rather than by operation of the definition of class III 
at section 513(a)(1)(C) of the FD&C Act. Thus, the second part of the 
proposed definition of class III (under paragraph (b)) will apply to 
initial classification of preamendments devices and reclassification 
decisions for a type of device, but will not control classification 
decisions FDA renders in reviewing a premarket notification under 
section 510(k) of the FD&C Act.
    The current regulatory definition closely tracks the statute, but 
it does not further explain the key statutory concept that determines 
which potentially high risk devices will be classified in class III--
namely, the concept of when insufficient information exists to 
determine that general and special controls would provide RASE. FDA's 
experience has shown that different stakeholders interpret this 
language differently. In some instances, FDA's stakeholders have 
suggested that premarket and postmarket controls typically associated 
with class III devices, such as requiring clinical trials to provide an 
independent assessment of the safety and effectiveness of a device, can 
be established as special controls. In other instances, FDA's 
stakeholders have suggested that all high risk devices should be 
classified in class III, even if those risks are well understood and 
may be able to be controlled through premarket studies showing 
equivalence to a marketed device, labeling, and other general or 
special controls.
    To address the need for greater clarity and promote consistent 
expectations about device classification, FDA is proposing to identify 
those potentially high risk devices for which insufficient information 
exists to determine that special and general controls would provide 
RASE. Under section 513(a)(2)(C) of the FD&C Act, the safety and 
effectiveness of a device are determined by evaluating its risks and 
benefits; thus, after FDA has determined a device is potentially high 
risk, FDA must still determine the risks, benefits, and appropriate 
regulatory controls to determine whether the device should be 
classified into class III. The proposed regulation would identify five 
categories of devices for classification into class III based on the 
risks, benefits, and available controls for the three device classes:
    Devices that present known risks that cannot be controlled. This 
category encompasses devices that have a favorable benefit- risk 
profile even though they present significant risks that cannot be 
adequately controlled through general and special controls. Because 
special controls cannot fully address the risks presented, the highest 
level of regulation is necessary to minimize those risks.
    Devices for which the risk-benefit profile is unknown or 
unfavorable. For most devices that enter the market each year after 
premarket review by FDA, FDA evaluates the safety and effectiveness of 
the device--and its risks and benefits--by determining in the context 
of the review of a premarket notification under section 510(k) of the 
FD&C Act whether the device is substantially equivalent to a legally 
marketed predicate device; thus, FDA assesses safety and effectiveness 
through a comparison to a predicate. FDA believes comparison to a 
predicate device is appropriate for the overwhelming majority of 
devices subject to premarket review, including many devices that are 
intended for use in supporting or sustaining human life, of substantial 
importance in preventing impairment of health, or that present a 
potential unreasonable risk of illness or injury.
    For certain potentially high risk technologies, however, the risks 
or benefits may not be sufficiently well understood to allow meaningful 
comparison of a device to a predicate device. If the risks and benefits 
of a device are unknown, FDA may be unable to identify the performance 
parameters relevant to risks and benefits that would allow FDA to 
assess safety and effectiveness through a comparison to a predicate. On 
the other hand, if FDA does have information concerning the risks and/
or benefits of a type of device, but the known benefits do not justify 
the known risks, there cannot be sufficient information to determine 
that general controls and special controls are sufficient to provide 
RASE, unless the applicant provides additional valid scientific 
evidence independently establishing a favorable benefit/risk profile 
for the device. The proposed rule would provide clear language 
classifying into class III potentially high risk devices for which the 
risk/benefit profile is unknown or unfavorable.
    Devices for which a full review of manufacturing information is 
necessary. Even when the risk/benefit profile of a device is well-
established, for certain potentially high risk devices, the risks may 
be of a type or degree that can only be adequately addressed by 
relatively stringent controls. Among the relatively stringent controls 
applied to class III devices are, in addition to the requirement for 
approval of an application containing valid scientific evidence 
independently establishing RASE for the device, the requirement to 
provide full manufacturing information about a device for FDA review 
before it may enter the market. FDA may be aware, for example, from 
experience with a particular device type, that certain aspects of the 
manufacturing process are critical to the safety or effectiveness of 
the device, which makes

[[Page 16256]]

review of the manufacturing process necessary prior to marketing.
    Because the statutory provision concerning special controls 
provides only an illustrative list of controls, leaving open the 
possibility other controls could be available as special controls, FDA 
believes it is important to identify those controls that are 
appropriate only for class III devices. FDA believes the flexibility 
provided by the statutory definition of special controls--and retained 
in the proposed regulatory definition--is appropriate and facilitates 
the goal of regulating device classes in the lowest regulatory class 
consistent with the protection of the public health. FDA also believes, 
however, that the statutory classification scheme contemplates that 
certain regulatory controls are appropriately reserved to class III 
devices subject to approval under section 515 of the FD&C Act. For 
example, section 515(c) of the FD&C Act specifically provides that a 
PMA is to include a full description of the methods used in, and the 
facilities and controls used for, the manufacture, processing, and, 
when relevant, packing and installation, of [a] device. This provision 
is in stark contrast to section 513(i) of the FD&C Act, which limits 
FDA's review of a premarket notification to a review of the intended 
use and technology of a device. In addition, section 513(f)(5), 
provides that FDA may not withhold a determination of the initial 
classification of a device under section 513(f)(1) because of a failure 
to comply with any provision of this chapter unrelated to a substantial 
equivalence decision, including a finding that the facility in which 
the device is manufactured is not in compliance with good manufacturing 
requirements as set forth in regulations of the Secretary under section 
360j(f) of this title (other than a finding that there is a substantial 
likelihood that the failure to comply with such regulations will 
potentially present a serious risk to human health).
    Differences in the types of information FDA reviews in 510(k)s and 
PMAs correspond to different review timeframes for these two 
application types; indeed, on the rare occasions that FDA has required 
a manufacturing inspection before clearance of a premarket notification 
for a device, FDA has found scheduling the inspection within the 90-day 
statutory timeframe for 510(k)s challenging. For all of these reasons, 
when a review of a full description of the methods used in, and the 
facilities and controls used for, the manufacture, processing, and, 
when relevant, packing and installation, of a device is necessary to 
provide RASE for a potentially high risk device, general and special 
controls are inadequate to provide RASE and the device thus meets the 
statutory definition of class III.
    Devices for which premarket review of any change affecting safety 
or effectiveness is necessary. Similarly, when approval of a premarket 
submission for any change to a device that affects safety or 
effectiveness is necessary to provide RASE, general and special 
controls are insufficient to provide RASE, and classification in class 
III is necessary. Section 515(d)(6) of the FD&C Act provides explicit 
authority to require premarket approval of a supplemental application 
for any change to an approved device that affects safety or 
effectiveness (with the exception of changes to certain manufacturing 
methods or procedures, for which a notice to FDA must be submitted 30 
days prior to implementation). FDA considers this to be a regulatory 
control reserved for class III devices. For higher risk devices with 
unique design characteristics or manufacturing processes, it is 
essential for FDA to assess any change that affects safety or 
effectiveness premarket to ensure that RASE is maintained, for example 
because of the cumulative impact that multiple changes may have on the 
safety or effectiveness of the device over time. FDA proposes that 
devices for which premarket review of any change that affects safety or 
effectiveness is necessary to provide RASE be classified in class III.
    Combination products. The last proposed category of class III 
devices are devices that provide the primary mode of action for 
combination products that include a drug constituent part for which a 
finding is required that the drug constituent part be safe and 
effective, or include a biological product constituent part for which a 
finding is required that the biological product constituent part be 
safe, pure, and potent, and such a finding has not been made. 
Accordingly, the proposed rule would classify such devices in class 
III, subject to premarket approval.
2. Other Definitions
    FDA proposes to amend the definition of generic type of device to 
address confusion about the inter-relationship among product code 
(procode), generic type, and classification regulation. In general, 
these represent levels of device categorization, with the lowest range 
of differences at the procode level and the highest range of 
differences at the classification regulation level, though sometimes 
the levels are coextensive. The terms ``device,'' ``device type,'' and 
``generic device type'' are often used in the FD&C Act and implementing 
regulations interchangeably. As explained in the guidance entitled 
``Medical Device Classification Product Codes--Guidance for Industry 
and Food and Drug Administration Staff,'' CDRH assigns three letter 
``procodes'' to devices to group and track them for various purposes. 
FDA proposes to amend the definition of ``generic type of device'' to 
make clear that a generic type may include one or more procodes, and a 
single classification regulation may include one or more generic types 
of device and may even, in some instances, straddle device classes.
    FDA proposes to remove the definitions for classification 
questionnaire and supplemental data sheet because FDA is proposing to 
remove the requirement that this form be included as part of the 
reclassification procedures under Sec.  860.84 and a reclassification 
petition under Sec.  860.123. FDA believes the proposed definitions, 
when finalized, will clarify the classification criteria for panels, 
FDA, and all stakeholders and thus obviate the need for this form.
    FDA proposes to add a definition of general controls for medical 
devices that harmonizes with the definition in section 513(a)(1)(A) of 
the FD&C Act. While explanations of general controls have been provided 
in guidance, adding the definition to this regulation will provide 
another opportunity to clarify which controls are included as general 
controls.
    FDA proposes to replace the term ``implant'' with the term 
``implantable device,'' which FDA proposes to have the same definition 
as ``implant.''
    FDA proposes to add a definition of special controls to clarify the 
regulatory significance of special controls as the controls necessary 
to provide RASE for a type of device classified in class II, which must 
be met for a device to be in class II.
    FDA proposes to add a definition of ``special controls guideline.'' 
Under section 513(a) of the FD&C Act, a special controls guideline is a 
means for providing RASE for a class II device. While the guideline 
establishes a mandatory level of regulatory controls that must be met 
for the device to be in class II, manufacturers may comply with the 
guideline either by following the particular controls described in the 
guideline or by using alternative mitigation measures but demonstrating 
to the Agency's satisfaction that those alternative measures provide 
the same or greater level of assurance of safety and effectiveness.

[[Page 16257]]

B. Proposed Amendments to 21 CFR 860.7--Determination of Safety and 
Effectiveness

    This section provides the relevant factors FDA and classification 
panels will consider in reviewing evidence of device safety and 
effectiveness. The proposed provision clarifies class II classification 
or reclassification requirements for safety and effectiveness. FDA 
proposes to amend Sec.  860.7(b) and (g)(1) to include establishment of 
special controls for class II devices, replacing the term performance 
standards because special controls include performance standards. Under 
section 513(a)(1)(B) of the FD&C Act, special controls includes the 
issuance of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines (including 
guidelines for the submission of clinical data in premarket 
notification of submissions in accordance with section 510(k)), 
recommendations and other appropriate actions as the FDA deems 
necessary to provide such assurance.
    FDA is proposing additional minor changes in paragraphs Sec.  
860.7(c)(2) and (d)(2) to update terminology and to reflect changes in 
the FD&C Act.

C. Proposed Amendments to 21 CFR Part 860.84--Classification Procedures 
for ``Preamendments Devices''

    This section explains the procedures and criteria for original 
classification of preamendments devices. FDA proposes to amend Sec.  
860.84 by removing the term ``old devices'' as a reference to medical 
devices in commercial distribution before May 28, 1976. The terminology 
FDA more commonly uses is ``preamendments devices.'' May 28, 1976, is 
the date of enactment of the Medical Device Amendments of 1976.
    FDA further proposes removing the requirement to answer the 
classification questionnaire and provide information using the 
supplemental data sheet. The classification questionnaire provides 
recommendations and information for FDA to consider during the 
classification process. The supplemental data sheet is information 
compiled by a classification panel or submitted in a petition for 
reclassification. As FDA has gained experience with the classification 
processes, questions concerning the utility of the classification 
questionnaire and supplemental data sheet have arisen. FDA believes 
that a more efficient use of FDA and petitioner resources would be to 
focus on the information the petitioner provides concerning review of 
available valid scientific evidence, appropriate regulatory controls 
given the risks presented by the device, and regulatory standards to 
understand whether general controls are sufficient to provide RASE or 
whether general controls and special controls are sufficient to provide 
RASE.
    FDA proposes to amend Sec.  860.84(d)(5) and (g)(2) to include 
establishment of special controls for class II devices. ``Special 
controls'' is the more inclusive term. Under section 513(a)(1)(B) of 
the FD&C Act, special controls includes the issuance of performance 
standards, postmarket surveillance, patient registries, development and 
dissemination of guidelines (including guidelines for the submission of 
clinical data in premarket notification of submissions in accordance 
with section 510(k)), recommendations, and other appropriate actions as 
the FDA deems necessary to provide such assurance.
    FDA proposes additional minor changes to Sec.  860.84(a), (d)(4), 
(d)(6), (e), and (g)(3) to reflect the changes in the FD&C Act and to 
update terminology.

D. Proposed New 21 CFR 860.90--Consultation With Panels

    FDA proposes to add a new section to explain how FDA consults with 
panels regarding classification of preamendments devices. This 
provision for the most part mirrors Sec.  860.125, which outlines the 
means by which FDA consults with panels for reclassifications.

E. Proposed Amendments to 21 CFR 860.93--Classification of Implantable 
Devices and Devices Intended for a Use in Supporting or Sustaining 
Human Life

    This section explains the special requirements for classifying any 
implantable device or device intended for a use in supporting or 
sustaining human life. FDA proposes to replace the term ``implant'' 
with the newly proposed term ``implantable device'' throughout this 
section. We also propose to add clarifying provisions that any class II 
classification recommendation for any implantable device or device 
intended for a use in supporting or sustaining human life from a 
classification device panel must identify and describe any special 
controls that are necessary to provide RASE. For any implantable device 
or device intended for a use in supporting or sustaining human life the 
Commissioner of Food and Drugs classifies or reclassifies into class 
II, the Commissioner must identify and describe any special controls 
that are necessary to provide RASE.

F. Proposed Amendments to 21 CFR 860.95--Exemptions From Sections 510, 
519, and 520(f) of the FD&C Act

    This section discusses exemptions from registration, product 
listing, and premarket notification in section 510 of the FD&C Act, 
records and reports in section 519 of the FD&C Act (21 U.S.C. 360i), 
and good manufacturing practice requirements in section 520(f) of the 
FD&C Act. FDA proposes additional changes to paragraphs Sec.  860.95(a) 
and (b) to reflect changes in the FD&C Act that a class II device may 
be exempted from the premarket notification requirements if premarket 
notification is not necessary to assure the safety and effectiveness of 
the device.

G. Proposed Amendments to 21 CFR 860.120--General

    This section explains the criteria for reclassifying medical 
devices under sections 513(e), 513(f), 514(b) (21 U.S.C. 360d(b)), 
515(b), and 520(l) of the FD&C Act. FDA proposes to remove the term 
``substantial equivalence'' in Sec.  860.120(b) to clarify that 
reclassifying one device within a generic type of device reclassifies 
all devices within a generic type of device. As clarified in the 
proposed amendment to the definition of ``generic type of device,'' a 
classification may include more than one generic type. Thus a 
reclassification may reclassify all of the devices within a 
classification (either because a classification only includes one 
generic type or because FDA has decided to reclassify more than one 
generic type) or only one or more generic types within a 
classification. FDA proposes to revise Sec.  860.120(c) to clarify that 
the Commissioner may reclassify class I, class II, and class III 
devices into any of the other of the three classes and to add 
provisions that list the sections of the FD&C Act under which the 
Commissioner may initiate reclassification of a medical device.

H. Proposed Amendments to 21 CFR 860.123--Reclassification Petition: 
Content and Form

    This section provides the form and content of reclassification 
petitions. FDA proposes to remove the requirement to include in a 
reclassification petition a completed classification questionnaire and 
supplemental data sheet. The classification questionnaire provides 
recommendations and information for FDA to consider during the 
classification process. The supplemental data sheet is information 
compiled by a classification panel or submitted in a petition for 
reclassification. As FDA has

[[Page 16258]]

gained experience with the classification processes, questions 
concerning the utility of the classification questionnaire and 
supplemental data sheet have arisen. FDA believes that a more efficient 
use of FDA and petitioner resources would be to focus on the 
information the petitioner provides concerning review of available 
valid scientific evidence, appropriate regulatory controls given the 
risks presented by the device, and regulatory standards to understand 
whether general controls are sufficient to provide RASE or whether 
general controls and special controls are sufficient to provide a 
reasonable assurance of safety and effectiveness.
    In paragraph Sec.  860.123(b)(2), FDA proposes to clarify a 
reference to section 513(f) in the FD&C Act to the more specific 
section 513(f)(3).

I. Proposed Amendments to 21 CFR 860.125--Consultation With Panels

    This section provides the procedures under which FDA's Commissioner 
consults with classification panels in the context of reclassification. 
FDA proposes to add language to clarify when consultation with a panel 
is required and when consultation is optional. In particular, FDA 
proposes to add language to Sec.  860.125(c) to reflect the FDASIA 
change that requires FDA to convene a classification panel meeting 
prior to reclassifying a device under section 513(e) of the FD&C Act.

J. Proposed Amendments to 21 CFR 860.130--General Procedures Under 
Section 513(e) of the FD&C Act

    This section provides the procedures for reclassifying a device 
based on new information under section 513(e) of the FD&C Act. FDA 
proposes to revise the procedure in Sec.  860.130(c) to reflect the 
FDASIA requirement that devices reclassified under section 513(e) of 
the FD&C Act be reclassified using an administrative order procedure. 
FDA also proposes to add language to clarify that the Commissioner may 
reclassify class I, class II, and class III devices into any of the 
other of the three classes under the criteria set forth in Sec.  860.3 
for each class of device.
    In Sec.  860.130(d) FDA proposes revisions to reflect the FDASIA 
process that FDA will use to reclassify a device under section 513(e) 
of the FD&C Act. Prior to the publication of a final order, FDA must 
also publish a proposed order in the Federal Register and consider any 
comments submitted on the proposed order. FDA must, in addition, hold a 
device classification panel meeting (21 U.S.C. 360c(b)). The panel 
meeting must occur before the final order is published, and may occur 
either before or after the proposed order is published. The proposed 
order must include the following: (1) A substantive summary of valid 
scientific evidence, including the public health benefits and risks of 
the device; (2) when reclassifying from class II to class III, an 
explanation that general and special controls are insufficient to 
reasonably assure safety and effectiveness; and (3) when reclassifying 
from class III to class II an explanation that general and special 
controls are sufficient to reasonably assure safety and effectiveness.
    FDA proposes revisions to Sec.  860.130 (f) and (g) to reflect the 
change to an administrative order process. FDA further proposes to 
revise Sec.  860.130(g) to reflect that the administrative order may 
establish special controls to provide RASE of the device.

K. Proposed Amendments to 21 CFR 860.132--Procedures When the 
Commissioner Initiates a Performance Standard or Premarket Approval 
Proceeding Under Sections 514(b) or 515(b) of the FD&C Act

    This section explains the procedures for an interested person to 
request reclassification of a device after FDA initiates a proceeding 
for the establishment of a performance standard or for requiring 
premarket approval. FDA proposes removing premarket approval 
proceedings from the process currently outlined in Sec.  860.132(b) 
since the corresponding statutory requirement was removed by FDASIA 
(pre-FDASIA section 515(b)(2)(B)) of the FD&C Act). Instead, FDA 
proposes new Sec.  860.132(b) and (c), providing that reclassification 
requests received during premarket approval proceedings will either be 
denied, if FDA does not agree that a change in classification is 
warranted, or granted, in which case FDA will follow the 
reclassification process under section 513(e) of the FD&C Act.
    FDA proposes new Sec.  860.132(d) for requests for reclassification 
during a performance standard proceeding, the process for which would 
remain largely unchanged. FDA proposes to remove the requirement in 
current Sec.  860.132(b)(3) that a grant or denial of a petition to 
reclassify a device must be by order published in the Federal Register. 
Publishing the administrative order in the Federal Register is not 
required by statute and adds an unnecessary step to the process. FDA 
proposes to extend the time for filing a petition for reclassification 
in Sec.  860.132(b)(1) to 30 days.

L. Proposed Addition of 21 CFR 860.133--Procedures When the 
Commissioner Initiates a Proceeding to Require Premarket Approval Under 
Section 515(b) of the FD&C Act

    FDA proposes to add Sec.  860.133 to describe the process for 
requiring the filing of a PMA for class III preamendments devices under 
section 515(b) of the FD&C Act (also referred to as a ``call for 
PMAs''). FDASIA changes the process that FDA uses to require the filing 
of PMAs or completion of PDPs from a rulemaking process to an 
administrative order process. Under proposed Sec.  860.133(b), a final 
order will include any recommendation to the Commissioner from a 
classification panel regarding the classification. Prior to the 
publication of a final order, FDA must also publish a proposed order in 
the Federal Register and consider any comments submitted on the 
proposed order. FDA must, in addition, hold a device classification 
panel meeting (21 U.S.C. 360c(b)). The panel meeting must occur before 
the final order is published, and may occur either before or after the 
proposed order is published. The proposed order must include the 
following: (1) A substantive summary of valid scientific evidence, 
including the public health benefits and risks of the device; (2) when 
reclassifying from class II to class III, an explanation that general 
and special controls are insufficient to reasonably assure safety and 
effectiveness; and (3) when reclassifying from class III to class II an 
explanation that general and special controls are sufficient to 
reasonably assure safety and effectiveness.

M. Proposed Amendments to 21 CFR 860.134--Procedures for 
``Postamendment Devices'' Under Section 513(f)(3) of the FD&C Act and 
Reclassification of Certain Devices

    This section explains the procedures for reclassifying 
postamendments devices that are class III by operation of section 
513(f)(1) of the FD&C Act. FDA proposes to amend Sec.  860.134 by 
removing the term ``new devices'' as a reference to medical devices in 
commercial distribution after May 28, 1976. The terminology FDA more 
commonly uses is ``postamendment devices.'' May 28, 1976, is the date 
of enactment of the Medical Device Amendments of 1976. FDA further 
proposes to clarify a reference to section 513(f) in the FD&C Act to 
the more specific section 513(f)(3) and to add a reference to ``de 
novo'' classification under section 513(f)(2) to Sec.  860.134(a) to 
reflect a change made by FDASIA to section 513(f)(1).

[[Page 16259]]

    FDA proposes to add new Sec.  860.134(c), detailing the process 
where reclassification is initiated by FDA rather than a petition. This 
process would consist of a proposed reclassification order, optional 
panel consultation, and a final reclassification order published in the 
Federal Register following consideration of comments and any panel 
recommendations or comments. FDA further proposes to add new paragraph 
860.134(d) to reflect that the administrative order may establish 
special controls to provide RASE of the device.

N. Proposed Amendments to 21 CFR 860.136--Procedures for Transitional 
Products Under Section 520(l) of the FD&C Act

    FDA proposes to revise Sec.  860.136(a) to add reclassification 
initiated by FDA and proposes to revise Sec.  860.136(b) to apply to 
reclassification initiated by manufacturer or importer.
    FDA proposes to add new Sec.  860.136(c), detailing the process 
where reclassification is initiated by FDA rather than a petition. This 
process would consist of a proposed reclassification order, optional 
panel consultation, and a final reclassification order published in the 
Federal Register following consideration of comments and any panel 
recommendations or comments. The proposed amendments to Sec.  860.136 
also include provisions making clear that reclassification orders under 
this section may establish special controls for a device reclassified 
into class II to provide RASE of the device. FDA also proposes to 
remove the requirement for a part 16 hearing because we believe the 
process providing for a proposed order, panel consultation, 
consideration of comments, and final order provide sufficient 
opportunity for participation and review of reclassifications of 
transitional devices.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

V. Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule imposes no significant new 
burdens, the Agency proposes to certify that the final rule would not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

B. Summary

    The reclassification process provides manufacturers a pathway to 
reclassify medical devices (e.g., reclassify from class III to class 
II). Although the process is intended to be straightforward, FDA has 
found that certain aspects of it lack clarity and as a result petitions 
have been submitted for devices that are not suitable candidates for 
reclassification. To make the process clearer, the rule proposes the 
following changes: (1) Removing repetitive sentences in the regulatory 
language; (2) using definitions that are consistent with the current 
statutory language; (3) and adding clarity to the definition of class 
III devices, which would make it more clear which devices currently 
regulated in class III are not suitable for down-classification.
    Adopting the proposed rule is expected to impose a modest net 
monetized benefit (estimated benefits minus estimated costs) on 
society. Benefits are attributed to making the reclassification process 
clearer, which would reduce the costs associated with preparing and 
reviewing reclassification petitions. We estimate annual benefits to 
roughly range from $1,535 to $2,880 per year. Using a 20-year time 
period, we estimate present discounted benefits to range between 
$22,837 to $42,847 at a 3 percent discount rate and $16,262 to $30,511 
at a 7 percent discount rate.
    FDA also examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires Agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. This proposed rule would impose no new burdens on small 
entities, and thus would not impose a significant economic impact on a 
substantial number of small entities.

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). A description of these provisions is given in the 
``Description'' section of this document with an estimate of the annual 
reporting burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility;

[[Page 16260]]

(2) the accuracy of FDA's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) ways to minimize 
the burden of the collection of information on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Reclassification Petitions for Medical Devices
    Description: This proposed rule would eliminate the requirement for 
petitioners to complete Form FDA 3429 (Classification Questionnaire) 
and Form FDA 3427 (Supplemental Data Sheet).
    Description of Respondents: The reporting requirements referenced 
in this document are imposed on any person petitioning for 
reclassification of a preamendments device and any manufacturer or 
importer of the device petitioning for reclassification of a 
postamendments or transitional device.
    Requirements Reflected in the Burden Estimates: FDA has identified 
the following requirements as having burdens that must be accounted for 
under the PRA; the burdens associated with these requirements are 
summarized in the tables that follow:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
860.123 Supporting data for                    6               1               6             497           2,982
 reclassification...............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Section 860.123 is being amended to eliminate the requirement for 
petitioners to complete Form FDA 3429 (Classification Questionnaire) 
and Form FDA 3427 (Supplemental Data Sheet).
    Based on current trends, FDA anticipates that six petitions will be 
submitted each year. The time required to prepare and submit a 
reclassification petition, including the time needed to assemble 
supporting data and to prepare the form, averages 497 hours per 
petition. This average is based upon estimates by FDA administrative 
and technical staff who are familiar with the requirements for 
submission of a reclassification petition, have consulted and advised 
manufacturers on these requirements, and have reviewed the 
documentation submitted.
    This proposed rule also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in Sec.  860.123 have been approved under OMB control number 0910-0138.
    To ensure that comments on these revised information collection 
requirements are received, OMB recommends that written comments be 
faxed to the Office of Information and Regulatory Affairs, OMB, Attn: 
FDA Desk Officer, FAX: 202-395-6974, or emailed to [email protected]. All comments should be identified with the 
title ``Reclassification Petitions for Medical Devices.'' In compliance 
with the PRA (44 U.S.C. 3507(d)), the Agency has submitted the 
information collection provisions of this proposed rule to OMB for 
review. These requirements will not be effective until FDA obtains OMB 
approval. FDA will publish a notice concerning OMB approval of these 
requirements in the Federal Register.

VIII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become 
effective 90 days after date of publication of a final rule in the 
Federal Register or at a later date if stated in the final rule.

IX. 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 
submit 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.

List of Subjects in 21 CFR Part 860

    Administrative practice and procedure, 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 860 be amended as follows:

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
1. The authority citation for 21 CFR part 860 continues to read as 
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
2. Section 860.3 is revised to read as follows:


Sec.  860.3  Definitions.

    For the purposes of this part:
    Act means the Federal Food, Drug, and Cosmetic Act.
    Class means one of the three categories of regulatory controls for 
medical devices. Class I, class II, and class III are defined below.
    Class I means the class of devices that are subject to only the 
general controls of the Federal Food, Drug, and Cosmetic Act. A device 
is in class I if:
    (1) General controls are sufficient to provide reasonable assurance 
of the safety and effectiveness of the device, or
    (2) There is insufficient information from which to determine that 
general controls are sufficient to provide reasonable assurance of the 
safety and effectiveness of the device or to establish special controls 
to provide such assurance, but the device:
    (i) Is not intended for a use in supporting or sustaining human 
life;
    (ii) Is not intended for a use that is of substantial importance in 
preventing impairment of human health; and
    (iii) Does not present a potential unreasonable risk of illness or 
injury.
    Class II means the class of devices for which general controls 
alone are insufficient to provide reasonable assurance of safety and 
effectiveness and for which sufficient information exists to establish 
special controls to provide such assurance. For a device that is 
intended for a use in supporting or sustaining human life, the 
Commissioner shall examine and establish the special controls, if any, 
that are necessary to provide a reasonable assurance of safety and 
effectiveness and describe how such controls provide such assurance.
    Class III means the class of devices for which premarket approval 
is or will be

[[Page 16261]]

required in accordance with section 515 of the Federal Food, Drug, and 
Cosmetic Act.
    (1) A device is in class III:
    (i) If so classified by the Federal Food, Drug, and Cosmetic Act 
under section 513(f)(1) or section 520(l)(1); or
    (ii) If the device:
    (A) Is intended for a use in supporting or sustaining human life, 
or
    (B) Is intended for a use that is of substantial importance in 
preventing impairment of human health, or
    (C) Presents a potential unreasonable risk of illness or injury; 
and
    (D) Insufficient information exists to determine that general 
controls and/or special controls are sufficient to provide reasonable 
assurance of safety and effectiveness.
    (2) The Commissioner may find that there is insufficient 
information to determine that general controls and/or special controls 
are sufficient to provide reasonable assurance of a device's safety and 
effectiveness. For example, the Commissioner may make this finding when 
any of the following apply:
    (i) The device presents known risks that cannot be adequately 
controlled by general and special controls;
    (ii) Evaluation under section 513(i) of the Federal Food, Drug, and 
Cosmetic Act is not adequate to establish that the benefit to health 
from use of the device justifies the risk of illness or injury from use 
of the device because:
    (A) The benefits of the device are unknown;
    (B) The risks of the device are unknown; or
    (C) The known benefits do not justify the known risks;
    (iii) Review of a full description of the methods used in, and the 
facilities and controls used for, the manufacture, processing, and, 
when relevant, packing and installation of, each device within the 
generic type is necessary to provide a reasonable assurance of safety 
and effectiveness;
    (iv) Review of a supplemental application in accordance with 
section 515(d)(6) of the Federal Food, Drug, and Cosmetic Act for any 
change to the device that affects safety or effectiveness is necessary 
to provide a reasonable assurance of safety and effectiveness; or
    (v) The device is part of a combination product as defined in 
section 3.2(e) of this chapter, the device constituent part provides 
the primary mode of action under section 503(g) of the Federal Food, 
Drug, and Cosmetic Act and part 3 of this chapter, and a finding is 
required that the drug constituent part be safe and effective or that 
the biological product constituent part be safe, pure, and potent, but 
such a finding has not been made.
    Classification panel means one of the advisory committees 
established by the Commissioner under section 513 of the Federal Food, 
Drug, and Cosmetic Act and part 14 of this chapter for the purpose of 
making recommendations to the Commissioner on the classification and 
reclassification of devices and for other purposes prescribed by the 
Federal Food, Drug, and Cosmetic Act or by the Commissioner.
    Commissioner means the Commissioner of Food and Drugs, Food and 
Drug Administration, United States Department of Health and Human 
Services, or the Commissioner's designee.
    General controls mean the controls authorized by or under sections 
501 (adulteration), 502 (misbranding), 510 (registration, listing, 
premarket notification, etc.), 516 (banned devices), 518 (notification 
and other remedies), 519 (records, reports, and unique device 
identification) and 520 (general provisions) of the Federal Food, Drug, 
and Cosmetic Act.
    Generic type of device means a grouping of devices that do not 
differ significantly in purpose, design, materials, energy source, 
function, or any other feature related to safety and effectiveness, and 
for which similar regulatory controls are sufficient to provide 
reasonable assurance of safety and effectiveness. Devices within a 
generic type of device are sometimes, but not always, grouped together 
under the same product code. Devices within a single classification 
sometimes, but not always, form a generic type of device.
    Implantable device means a device that is intended to be placed in 
a surgically or naturally formed cavity of the human body. A device is 
regarded as an implantable device for the purpose of this part only if 
it is intended to remain implanted continuously for a period of 30 days 
or more, unless the Commissioner determines otherwise in order to 
protect human health.
    Petition means a submission seeking reclassification of a device in 
accordance with Sec.  860.123.
    Special controls mean the controls necessary to provide a 
reasonable assurance of safety and effectiveness for a generic type of 
device within class II and that must be met to establish and maintain 
classification within the generic type. Special controls can include a 
wide variety of regulatory controls necessary to provide reasonable 
assurance of the safety and effectiveness of the device, such as the 
promulgation of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines (including 
guidelines for the submission of clinical data in premarket 
notification submissions in accordance with section 510(k) of the 
Federal Food, Drug, and Cosmetic Act), recommendations, and other 
appropriate actions as the Commissioner deems necessary to provide such 
assurance.
    Special controls guideline is a type of document referenced in the 
codified text of the applicable classification regulation that 
establishes the special controls necessary to provide a reasonable 
assurance of safety and effectiveness for a generic type of class II 
device, such as the type and level of data (clinical or other 
performance data) to be included in premarket notification submissions, 
labeling, postmarket reporting, and/or other controls. Special controls 
guidelines establish a mandatory level of regulatory control, but 
permit flexibility in how to meet the level of control necessary to 
provide a reasonable assurance of safety and effectiveness. A 
manufacturer of a device subject to a special controls guideline must 
comply with the guideline, in order for the device to be in class II, 
by complying with the particular mitigation measures described in the 
guideline or by using alternative mitigation measures but demonstrating 
to the Agency's satisfaction that those alternative measures provide at 
least an equivalent assurance of safety and effectiveness.
    Supporting or sustaining human life means essential to, or yields 
information that is essential to, the restoration or continuation of a 
bodily function important to the continuation of human life.
0
3. Section 860.7 is amended by revising paragraph (b) introductory 
text, the last sentence in paragraph (c)(2), paragraph (d)(2), and the 
last sentence in paragraph (g)(1) to read as follows:


Sec.  860.7  Determination of safety and effectiveness.

* * * * *
    (b) In determining the safety and effectiveness of a device for 
purposes of classification, establishment of special controls for class 
II devices, and premarket approval of class III devices, the 
Commissioner and the classification panels will consider the following, 
among other relevant factors:
* * * * *
    (c) * * *
    (2) * * * Such information may be considered, however, in 
identifying a device with questionable safety or effectiveness.
    (d) * * *

[[Page 16262]]

    (2) Among the types of evidence that may be required, when 
appropriate, to determine that there is reasonable assurance that a 
device is safe are investigations using laboratory animals, 
investigations involving human subjects, and nonclinical 
investigations, and analytical studies for in vitro diagnostic devices.
* * * * *
    (g)(1) * * * The failure of a manufacturer or importer of a device 
to present to the Food and Drug Administration adequate, valid 
scientific evidence showing that there is reasonable assurance of the 
safety and effectiveness of the device, if regulated by general 
controls alone, or by general controls and special controls, may 
support a determination that the device be classified into class III.
* * * * *
0
4. Section 860.84 is amended by revising the section heading and 
paragraph (a), removing paragraphs (c)(3) and (4), redesignating 
paragraph (c)(5) as paragraph (c)(3), and revising paragraphs (d)(2), 
(d)(4) through (6), (e), and (g)(2) and (3).
    The revisions read as follows:


Sec.  860.84  Classification procedures for ``preamendments devices.''

    (a) This subpart sets forth the procedures for the original 
classification of a generic type of device that was in commercial 
distribution before May 28, 1976. Such a device will be classified by 
regulation into either class I (general controls), class II (special 
controls) or class III (premarket approval), depending upon the level 
of regulatory control required to provide reasonable assurance of the 
safety and effectiveness of the device (Sec.  860.3). This subpart does 
not apply to a device that is classified into class III by statute 
under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act 
because the Food and Drug Administration has determined that the device 
is not ``substantially equivalent'' to any device subject to this 
subpart or under section 520(l)(1) of the Federal Food, Drug, and 
Cosmetic Act because the device was regarded previously as a new drug. 
In classifying a device under this section, the Food and Drug 
Administration will follow the procedures described in paragraphs (b) 
through (g) of this section.
* * * * *
    (d) * * *
    (2) A summary of the data upon which the recommendation is based;
* * * * *
    (4) In the case of a recommendation for classification into class 
I, a recommendation as to whether the device should be exempt from the 
requirements of one or more of the following sections of the Federal 
Food, Drug, and Cosmetic Act: section 510 (registration, product 
listing, and premarket notification), section 519 (records and reports) 
and section 520(f) (good manufacturing practice requirements of the 
quality system regulation) in accordance with Sec.  860.95, and, in the 
case of a recommendation for classification into class II, whether the 
device should be exempted from the premarket notification requirement 
under section 510;
    (5) In the case of a recommendation for classification into class 
II or class III, to the extent practicable, a recommendation for the 
assignment to the device of a priority for the application of a 
performance standard or a premarket approval requirement, and in the 
case of classification into class II, a recommendation on the 
establishment of special controls and whether the device should be 
exempted from premarket notification;
    (6) In the case of a recommendation for classification of an 
implantable device or a device intended for a use in supporting or 
sustaining human life into class I or class II, a statement of why 
premarket approval is not necessary to provide reasonable assurance of 
the safety and effectiveness of the device, accompanied by references 
to supporting documentation and data satisfying the requirements of 
Sec.  860.7, and an identification of the risks to health, if any, 
presented by the device.
    (e) A panel recommendation is regarded as preliminary until the 
Commissioner has reviewed it, discussed it with the panel if 
appropriate, and published a proposed regulation classifying the 
device. Preliminary panel recommendations are filed in the Division of 
Dockets Management's office upon receipt and are available to the 
public and posted on FDA's Web site at http://www.regulations.gov.
* * * * *
    (g) * * *
    (2) If classifying the device into class II, establish the special 
controls for the device and prescribe whether the premarket 
notification requirement will apply to the device;
    (3) If classifying an implantable device, or a device intended for 
a use in supporting or sustaining human life, comply with Sec.  
860.93(b).
0
5. Section 860.90 is added to read as follows:


Sec.  860.90  Consultation with panels.

    (a) When the Commissioner is required to consult with a panel 
concerning a classification under Sec.  860.84, the Commissioner will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members; or
    (2) Discussion at a panel meeting.
    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter 
involved and the time available for action. When time and circumstances 
permit, the Commissioner will consult with a panel through discussion 
at a panel meeting.
0
6. Revise Sec.  860.93 to read as follows:


Sec.  860.93  Classification of implantable devices and devices 
intended for a use in supporting or sustaining human life.

    (a) A classification panel will recommend classification into class 
III of any implantable device or device intended for a use in 
supporting or sustaining human life unless the panel determines that 
such classification is not necessary to provide reasonable assurance of 
the safety and effectiveness of the device. If the panel recommends 
classification or reclassification of such a device into a class other 
than class III, it shall set forth in its recommendation the reasons 
for so doing and an identification of the risks to health, if any, 
presented by the device. In the case of such a device being recommended 
for classification or reclassification into class II, the panel shall 
describe the special controls that, in addition to general controls, 
are necessary to provide a reasonable assurance of safety and 
effectiveness of the device and how such controls provide such 
assurance.
    (b) The Commissioner will classify an implantable device or a 
device intended for a use in supporting or sustaining human life into 
class III unless the Commissioner determines that such classification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. If the Commissioner proposes to classify 
or reclassify such a device into a class other than class III, the 
regulation or order effecting such classification or reclassification 
will be accompanied by a full statement of the reasons for so doing. A 
statement of the reasons for not classifying or retaining the device in 
class III may be in the form of concurrence with the reasons for the 
recommendation of the classification panel, together with supporting

[[Page 16263]]

documentation and data satisfying the requirements of Sec.  860.7 and 
an identification of the risks to health, if any, presented by the 
device. In the case of such a device being classified or reclassified 
into class II, the Commissioner shall describe the special controls 
that, in addition to general controls, are necessary to provide a 
reasonable assurance of safety and effectiveness of the device and how 
such controls provide such assurance.
0
7. Section 860.95 is amended by revising the section heading and 
paragraphs (a) and (b) to read as follows:


Sec.  860.95  Exemptions from sections 510, 519, and 520(f) of the 
Federal Food, Drug, and Cosmetic Act.

    (a) A panel recommendation to the Commissioner that a device be 
classified or reclassified into class I will include a recommendation 
as to whether the device should be exempt from some or all of the 
requirements of one or more of the following sections of the Federal 
Food, Drug, and Cosmetic Act: Section 510 (registration, product 
listing, and premarket notification), section 519 (records and reports) 
and section 520(f) (good manufacturing practice requirements of the 
quality system regulation), and, in the case of a recommendation for 
classification into class II, whether the device should be exempted 
from the premarket notification requirement under section 510.
    (b) A regulation or an order classifying or reclassifying a device 
into class I will specify which requirements, if any, of sections 510, 
519, and 520(f) of the Federal Food, Drug, and Cosmetic Act the device 
is to be exempted from or, in the case of a regulation or an order 
classifying or reclassifying a device into class II, whether the device 
is to be exempted from the premarket notification requirement under 
section 510, together with the reasons for such exemption.
* * * * *
0
8. Section 860.120 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  860.120  General.

* * * * *
    (b) The criteria for determining the proper class for a device are 
set forth in Sec.  860.3. The reclassification of any device within a 
generic type of device causes the reclassification of all devices 
within that generic type. Accordingly, a petition for the 
reclassification of a specific device will be considered a petition for 
reclassification of all devices within the same generic type.
    (c) Any interested person may submit a petition for 
reclassification under section 513(e), 514(b), or 515(b) of the Federal 
Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a 
petition for reclassification under section 513(f) or 520(l) of the 
Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the 
reclassification of a device under the following sections of the 
Federal Food, Drug, and Cosmetic Act:
    (1) Section 513(e) (for a device other than a device classified 
under section 513(f) or 520(l)(1) of the Federal Food, Drug, and 
Cosmetic Act);
    (2) Section 513(f)(3) (for a device classified into class III under 
section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or
    (3) Section 520(l)(2) (for a device classified into class III under 
section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).
0
9. Section 860.123 is amended by removing paragraphs (a)(3) and (4), 
redesignating paragraphs (a)(5) through (10) as paragraphs (a)(3) 
through (8), respectively; and revising paragraph (b)(2).
    The revision reads as follows:


Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (2) Marked clearly with the section of the Federal Food, Drug, and 
Cosmetic Act under which the petition is being submitted, i.e., 
``513(e),'' ``513(f)(3),'' ``514(b),'' ``515(b),'' or ``520(l) 
Petition'';
* * * * *
0
10. Section 860.125 is amended by revising paragraphs (a) introductory 
text and (a)(2), redesignating paragraph (c) as paragraph (d) and 
revising it, and adding a new paragraph (c) to read as follows:


Sec.  860.125  Consultation with panels.

    (a) When the Commissioner chooses to refer a reclassification 
petition to a classification panel for its recommendation under Sec.  
860.134(b), or the Commissioner is required to consult with a panel 
concerning a reclassification petition under Sec.  860.132(d) or Sec.  
860.136, or the Commissioner chooses to consult with a panel with 
regard to the reclassification of a device initiated by the 
Commissioner under Sec.  860.134(c) or Sec.  860.136, the Commissioner 
will distribute a copy of the petition, or its relevant portions, if 
applicable, to each panel member and will consult with the panel in one 
of the following ways:
* * * * *
    (2) Consultation by mail with at least a majority of current voting 
panel members and, when possible, nonvoting panel members; or
* * * * *
    (c) The Commissioner will consult with a classification panel prior 
to changing the classification of a device under section 513(e) of the 
Federal Food, Drug, and Cosmetic Act and Sec.  860.130 upon the 
Commissioner's own initiative or upon petition of an interested person, 
and in the latter case, the Commissioner will distribute a copy of the 
petition, or its relevant portions, to each panel member.
    (d) When a petition is submitted under Sec.  860.134 for a 
postamendments, not substantially equivalent device (``new device''), 
if the Commissioner chooses to consult with the panel, the Commissioner 
will obtain a recommendation that includes the information described in 
Sec.  860.84(d). In consulting with a panel about a petition submitted 
under Sec.  860.130, Sec.  860.132, or Sec.  860.136, the Commissioner 
may or may not obtain a formal recommendation.
0
11. Section 860.130 is amended by revising the section heading and 
paragraphs (c) through (g) to read as follows:


Sec.  860.130  General procedures under section 513(e) of the Federal 
Food, Drug, and Cosmetic Act.

* * * * *
    (c) By administrative order published under this section, the 
Commissioner may change the classification from:
    (1) Class I or II to class III if the Commissioner determines that 
the device meets the criteria set forth in Sec.  860.3 for a class III 
device; or
    (2) Class III or class I to class II if the Commissioner determines 
that the device meets the criteria set forth in Sec.  860.3 for a class 
II device; or
    (3) Class III or class II to class I if the Commissioner determines 
that the device meets the criteria set forth in Sec.  860.3 for a class 
I device.
    (d)(1) The Commissioner shall consult with a classification panel 
and may secure a recommendation with respect to reclassification of a 
device from a classification panel. The panel will consider 
reclassification in accordance with the consultation procedures of 
Sec.  860.125. A recommendation submitted to the Commissioner by the 
panel will be published in the Federal Register when the Commissioner 
publishes an administrative order under this section.
    (2) The Commissioner may change the classification of a device by 
administrative order published in the Federal Register following 
publication

[[Page 16264]]

of a proposed reclassification order in the Federal Register, a meeting 
of a device classification panel described in section 513(b) of the 
Federal Food, Drug, and Cosmetic Act, and consideration of comments to 
a public docket. The meeting of a device classification panel may take 
place at any time before or after the publication of a proposed 
reclassification order in the Federal Register.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner will either deny 
the petition by order published in the Federal Register or give notice 
of the intent to initiate a change in the classification of the device.
    (f) If a device is reclassified under this section, the 
administrative order effecting the reclassification may revoke any 
special control or premarket approval requirement that previously 
applied to the device but that is no longer applicable because of the 
change in classification.
    (g) An administrative order under this section changing the 
classification of a device to class II may provide that such 
classification will not take effect until the effective date of a 
performance standard for the device established under section 514 of 
the Federal Food, Drug, and Cosmetic Act or other special controls 
established under the order. An order under this section changing the 
classification of a device to class II may also establish the special 
controls necessary to provide reasonable assurance of the safety and 
effectiveness of the device.
0
12. Amend Sec.  860.132 as follows:
0
a. Revise the section heading and paragraph (a);
0
b. Redesignate paragraph (b) as paragraph (d);
0
c. Revise newly redesignated paragraphs (d) introductory text, (d)(1), 
and (d)(3); and
0
d. Add new paragraph (b) and paragraph (c).
    The revisions and additions read as follows:


Sec.  860.132  Procedures when the Commissioner initiates a performance 
standard or premarket approval proceeding under section 514(b) or 
515(b) of the Federal Food, Drug, and Cosmetic Act.

    (a) Sections 514(b) and 515(b) of the Federal Food, Drug, and 
Cosmetic Act require the Commissioner to provide, by notice in the 
Federal Register, an opportunity for interested parties to request a 
change in the classification of a device based upon new information 
relevant to its classification when the Commissioner initiates a 
proceeding to develop a performance standard for the device if in class 
II or to issue an order requiring premarket approval for the device if 
in class III.
    (b) If the Commissioner agrees that the new information submitted 
in response to a proposed order to require premarket approval of a 
device issued under section 515(b) of the Federal Food, Drug, and 
Cosmetic Act warrants a change in classification, the Commissioner 
shall follow the procedures under section 513(e) of the Federal Food, 
Drug, and Cosmetic Act and Sec.  860.130 to effect such a change.
    (c) If the Commissioner does not agree that the new information 
submitted in response to a proposed order to require premarket approval 
of a device issued under section 515(b) of the Federal Food, Drug, and 
Cosmetic Act warrants a change in classification, the Commissioner will 
deny the petition.
    (d) The procedures under section 514(b) of the Federal Food, Drug, 
and Cosmetic Act are as follows:
    (1) Within 30 days after publication of the Commissioner's notice 
referred to in paragraph (a) of this section, an interested person 
files a petition for reclassification in accordance with Sec.  860.123.
* * * * *
    (3) Within 60 days after publication of the notice referred to in 
paragraph (a) of this section, the Commissioner either denies the 
petition or gives notice of the intent to initiate a change in 
classification in accordance with Sec.  860.130.
0
13. Add Sec.  860.133 to read as follows:


Sec.  860.133  Procedures when the Commissioner initiates a proceeding 
to require premarket approval under section 515(b) of the Federal Food, 
Drug, and Cosmetic Act.

    (a) Section 515(b) of the Federal Food, Drug, and Cosmetic Act 
applies to proceedings to require premarket approval for a class III 
preamendments device.
    (b) The Commissioner may require premarket approval for a class III 
preamendments device by administrative order published in the Federal 
Register following publication of a proposed order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the Federal Food, Drug, and Cosmetic Act, and 
consideration of comments from all affected stakeholders, including 
patients, payors and providers. The meeting of a device classification 
panel may take place at any time before or after the publication of a 
proposed order in the Federal Register. Any recommendation submitted to 
the Commissioner by the panel will be published in the Federal Register 
when the Commissioner publishes an administrative order under this 
section.
0
14. Section 860.134 is amended by revising the section heading and 
paragraph (a)(3), adding paragraph (a)(4), revising paragraphs (b) 
introductory text and (b)(4) and (6), and adding paragraphs (c) and (d) 
to read as follows:


Sec.  860.134  Procedures for reclassification of ``postamendments 
devices'' under section 513(f)(3) of the Federal Food, Drug, and 
Cosmetic Act.

    (a) * * *
    (3) The Commissioner has classified the device into class I or 
class II in response to a petition for reclassification under this 
section.
    (4) The device is classified under a request for ``de novo'' 
classification under section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The procedures for effecting reclassification under section 
513(f)(3) of the Federal Food, Drug, and Cosmetic Act when initiated by 
a manufacturer or importer are as follows:
* * * * *
    (4) Within 90 days after the date the petition is referred to the 
panel, following the review procedures set forth in Sec.  860.84(c) for 
the original classification of a ``preamendments device'', the panel 
submits to the Commissioner its recommendation containing the 
information set forth in Sec.  860.84(d). A panel recommendation is 
regarded as preliminary until the Commissioner has reviewed it, 
discussed it with the panel, if appropriate, and developed a proposed 
reclassification order. Preliminary panel recommendations are filed in 
the Division of Dockets Management upon receipt and are available to 
the public and posted at http://www.regulations.gov.
* * * * *
    (6) Within 90 days after the panel's recommendation is received 
(and no more than 210 days after the date the petition was filed), the 
Commissioner denies or approves the petition by order in the form of a 
letter to the petitioner. If the Commissioner approves the petition, 
the order will classify the device into class I or class II in 
accordance with the criteria set forth in Sec.  860.3 and subject to 
the applicable requirements of Sec.  860.93, relating to the 
classification of implantable devices and devices intended for a use in 
supporting or sustaining human life, and Sec.  860.95, relating to 
exemptions

[[Page 16265]]

from certain requirements of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    (c) By administrative order published under section 513(f)(3) of 
the Federal Food, Drug, and Cosmetic Act, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 513(f)(1) either to class II, if the Commissioner 
determines that special controls in addition to general controls are 
necessary and sufficient to provide reasonable assurance of the safety 
and effectiveness of the device and there is sufficient information to 
establish special controls to provide such assurance, or to class I if 
the Commissioner determines that general controls alone would provide 
reasonable assurance of the safety and effectiveness of the device. The 
procedures are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) Before or after the publication of a proposed reclassification 
order, the Commissioner may consult with the appropriate classification 
panel with respect to the reclassification of the device. The panel 
will consider reclassification in accordance with the consultation 
procedures of Sec.  860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the 
safety and effectiveness of the device.
0
15. Amend Sec.  860.136 as follows:
0
a. Revise the section heading, paragraph (a), and paragraph (b) 
introductory text;
0
b. Remove paragraph (b)(3);
0
c. Redesignate paragraphs (b)(4) through (6) as paragraphs (b)(3) 
through (5), respectively;
0
d. Revise newly redesignated paragraph (b)(4); and
0
e. Add paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  860.136   Procedures for transitional products under section 
520(l) of the Federal Food, Drug, and Cosmetic Act.

    (a) Section 520(l)(2) of the Federal Food, Drug, and Cosmetic Act 
applies to reclassification proceedings initiated by the Commissioner 
or in response to a request by a manufacturer or importer for 
reclassification of a device currently in class III by operation of 
section 520(l)(1). This section applies only to devices that the Food 
and Drug Administration regarded as ``new drugs'' before May 28, 1976.
    (b) The procedures for effecting reclassification under section 
520(l) of the Federal Food, Drug, and Cosmetic Act when initiated by a 
manufacturer or importer are as follows:
* * * * *
    (4) Within 180 days after the petition is filed (where the 
Commissioner has determined it to be adequate for review), the 
Commissioner, by order in the form of a letter to the petitioner, 
either denies the petition or classifies the device into class I or 
class II in accordance with the criteria set forth in Sec.  860.3.
* * * * *
    (c) By administrative order, the Commissioner may, on the 
Commissioner's own initiative, change the classification from class III 
under section 520(l) of the Federal Food, Drug, and Cosmetic Act either 
to class II, if the Commissioner determines that special controls in 
addition to general controls are necessary and sufficient to provide 
reasonable assurance of the safety and effectiveness of the device and 
there is sufficient information to establish special controls to 
provide such assurance, or to class I if the Commissioner determines 
that general controls alone would provide reasonable assurance of the 
safety and effectiveness of the device. The procedures are as follows:
    (1) The Commissioner publishes a proposed reclassification order in 
the Federal Register seeking comment on the proposed reclassification.
    (2) Before or after the publication of a proposed reclassification 
order, the Commissioner may consult with the appropriate classification 
panel with respect to the reclassification of the device. The panel 
will consider reclassification in accordance with the consultation 
procedures of Sec.  860.125.
    (3) Following consideration of comments to a public docket and any 
panel recommendations or comments, the Commissioner may change the 
classification of a device by final administrative order published in 
the Federal Register.
    (d) An administrative order under this section changing the 
classification of a device from class III to class II may establish the 
special controls necessary to provide reasonable assurance of the 
safety and effectiveness of the device.

    Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06364 Filed 3-21-14; 11:15 am]
BILLING CODE 4160-01-P