
[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47651-47653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]


De Novo Classification Process (Evaluation of Automatic Class III 
Designation); Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``De Novo Classification 
Process

[[Page 47652]]

(Evaluation of Automatic Class III Designation).'' The purpose of this 
document is to provide FDA's proposals for guidance to FDA staff and 
industry on the process for the submission and review of petitions 
submitted under the Evaluation of Automatic Class III Designation 
section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
also known as the de novo classification process. FDA is issuing this 
draft guidance to provide proposed updated recommendations for 
efficient interaction with FDA, including what information to submit 
when seeking a path to market for a novel device via the de novo 
process. This draft guidance has been revised and is being reissued for 
comment because the Food and Drug Administration Safety and Innovation 
Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act to 
provide for the submission of de novos without a preceding premarket 
notification (510(k)) submission. This draft guidance is not final nor 
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 14, 2014. Submit either electronic or written 
comments concerning proposed collection of information by October 14, 
2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``De Novo Classification Process (Evaluation 
of Automatic Class III Designation)'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616, 
melissa.burns@fda.hhs.gov; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    A medical device that is of a new type that FDA has not yet 
classified, and therefore cannot be found to be substantially 
equivalent to a legally marketed predicate device, is ``automatically'' 
or ``statutorily'' classified into class III by operation of section 
513(f)(1) of the FD&C Act (21 U.S.C. 360c(f)(1)) even if the risks it 
presents are relatively low. This is the scenario contemplated by 
Congress when it enacted section 513(f)(2) of the FD&C Act (21 U.S.C. 
360c(f)(2)) as part of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA). The process created by this provision is referred 
to in FDAMA as the Evaluation of Automatic Class III Designation (e.g., 
the de novo process). Congress included this section to limit 
unnecessary expenditure of FDA and industry resources that could occur 
if lower risk devices were subject to premarket approval under section 
515 of the FD&C Act (21 U.S.C. 360e).
    Section 513(f)(2) of the FD&C Act was amended again by Congress 
under section 607 of FDASIA (Pub. L. 112-144) in 2012. Section 
513(f)(2) provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1) of 
the FD&C Act. Under the first procedure, the person submits a premarket 
notification under section 510(k) of the FD&C Act for a device that has 
not previously been classified and, after receiving an order 
classifying the device into class III under section 513(f)(1), the 
person requests a classification under section 513(f)(2) of the FD&C 
Act. Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) of the FD&C Act and then a 
request for classification under the first procedure, the person 
determines that there is no legally marketed device upon which to base 
a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act.
    On October 3, 2011, FDA published a notice of availability of a 
draft guidance document on the de novo classification process (76 FR 
61103). The comment period closed on December 2, 2011. After the 
passage of FDASIA in 2012 added a procedure by which a person may 
request FDA to classify a device under 513(f)(2) of the FD&C Act, FDA 
decided it should revise the 2011 draft guidance to include 
recommendations regarding the second procedure. Accordingly, FDA is 
issuing this draft guidance to provide updated proposed recommendations 
designed to foster efficient interaction with FDA, including what 
information to submit, when seeking a path to market via the de novo 
process. This draft guidance describes a proposed mechanism to provide 
greater clarity about the process for de novo review and the type of 
data necessary to support de novo classification of an eligible device.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the de novo 
classification process. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``De Novo 
Classification Process (Evaluation of Automatic Class III 
Designation)'' may send an email request to CDRH-Guidance@fda.hhs.gov 
to receive an electronic copy of the document. Please use the document 
number 1769 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3502), Federal 
Agencies

[[Page 47653]]

must obtain approval from the Office of Management and Budget (OMB) for 
each collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c) (2)(A) of the PRA (44 U.S.C. 3506 (c) (2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these 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; (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.
Draft Guidance for Industry and Food and Drug Administration Staff: De 
Novo Classification Process (Evaluation of Automatic Class III 
Designation)
    This draft guidance describes how CDRH and CBER intend to implement 
section 513(f)(2) of the FD&C Act. Section 513(f)(2) provides two 
procedures by which a person may request FDA to classify a device under 
the criteria set forth in section 513(a)(1) of the FD&C Act. Under the 
first procedure (section 513(f)(2)(i)), the person submits a premarket 
notification under section 510(k) of the FD&C Act for a device that has 
not previously been classified and, after receiving an order 
classifying the device into class III under section 513(f)(1), the 
person requests a classification under section 513(f)(2) of the FD&C 
Act. Under the second procedure (section 513(f)(2)(ii) of the FD&C 
Act), rather than first submitting a premarket notification under 
section 510(k) of the FD&C Act and then a request for classification 
under the first procedure, the person determines that there is no 
legally marketed device upon which to base a determination of 
substantial equivalence and requests a classification under section 
513(f)(2) of the FD&C Act. When final, this document will supersede 
``New Section 513(f)(2)--Evaluation of Automatic Class III Designation, 
Guidance for Industry and CDRH Staff'' dated February 19, 1998.
    The proposed collections of information are necessary to satisfy 
the previously mentioned statutory requirements for implementing this 
voluntary submission program.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
Submission of information for de     Number of     responses per   Total annual   per respondent    Total hours
   novo classification program      respondents     respondent       responses      (in hours)
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CDRH (21 U.S.C. 513(f)(2)(i))...              25               1              25             100           2,500
CBER (21 U.S.C. 513(f)(2)(i))...               1               1               1             100             100
CDRH (21 U.S.C. 513(f)(2)(ii))..              25               1              25             180           4,500
CBER (21 U.S.C. 513(f)(2)(ii))..               1               1               1             180             180
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    Total.......................  ..............  ..............  ..............  ..............           7,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers seeking to market 
medical device products that have been classified into class III under 
section 513(f)(2) of the FD&C Act. Based on FDA's experience with the 
de novo classification program, FDA expects the program to continue to 
be utilized as a viable program in the future. It is expected that the 
number of de novos will increase over its current rate and reach a 
steady rate of approximately 50 submissions per year.
    FDA estimates from past experience with the de novo petition 
program that the complete process involved with the program under 
section 513(f)(2)(i) of the FD&C Act takes approximately 100 hours. FDA 
estimates from past experience with the de novo petition program that 
the complete process involved with the program under section 
513(f)(2)(i)(ii) FD&C Act takes approximately 180 hours. This average 
is based upon estimates by FDA administrative and technical staff who 
are familiar with the requirements for submission of a de novo petition 
(and related materials), have consulted and advised manufacturers on 
these requirements, and have reviewed the documentation submitted. 
Therefore, the total reporting burden hours is estimated to be 7,280 
hours.
    This draft guidance also refers to currently approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 807, subpart E, are approved under OMB control number 0910-
0120.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19253 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P


