
[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61103-61105]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Food and Drug Administration 
Staff; De Novo Classification Process (Evaluation of Automatic Class 
III Designation); 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availability of the draft guidance entitled ``De Novo Classification 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 (Evaluation of Automatic Class III Designation).'' The purpose 
of this document is to provide guidance to FDA staff and industry on 
the process for the submission and review of petitions submitted under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the 
de novo classification process. FDA is issuing this draft guidance to 
provide 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 This draft guidance is not 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draft guidance before it begins work on the

[[Page 61104]]

final version of the guidance, submit either electronic or written 
comments on the draft guidance by December 2, 2011. Submit either 
electronic or written comments concerning proposed collection of 
information by December 2, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``De Novo Classification Process (Evaluation 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 Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002 or 
to the Office of Communication, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your request, or fax 
your request to 301-847-8149. 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; 
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210.

I. Background

    A medical device that is of a new type that FDA has not yet 
classified based on risk, and therefore cannot be found to be 
substantially equivalent to a legally marketed predicate device, may 
remain in class III even if the risks it presents are relatively low. 
This is the scenario targeted 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).
    FDA issued a guidance document to explain the procedures involved 
with the de novo program, which has been in place since 1998. Over the 
past 13 years, even though a number of new medical devices have been 
evaluated by FDA under the de novo process, FDA believes that the 
program has been under-utilized, and has evaluated what improvements 
could be made to enhance the utility and productivity of the program. 
FDA evaluated its extensive experience gained with respect to the 
evidence necessary to conduct comprehensive reviews of de novo 
applications. Accordingly, FDA is issuing this draft guidance to 
provide updated 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 guidance 
describes a mechanism to provide greater clarity about the suitability 
of a device for de novo review, and timely input on 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 using 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 from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``De 
Novo Classification Process (Evaluation of Automatic Class III 
Designation),'' from CDRH you may either send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1769 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3502), Federal Agencies 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 FDA's Center for Devices and 
Radiological Health (CDRH) and Center for Biologics Evaluation and 
Research (CBER) intend to implement this provision of the law. 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.

[[Page 61105]]

    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
Submission of information for de     Number of     responses per   Total annual     burden per
      novo petition program         respondents   respondent per     responses      respondent      Total hours
                                                       year                         (in hours)
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CDRH............................              25               1              25             100           2,500
CBER............................               1               1               1             100             100
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,600
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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 petition program, FDA expects the program to continue to be 
utilized as a viable program in the future. It is expected that the 
number of petitions will increase over its current rate and reach a 
steady rate of approximately 26 submissions per year
    FDA estimates from past experience with the de novo petition 
program that the complete process involved with the program takes 
approximately 100 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 
2,600 hours.

                                                     Table 2
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                                                                 Total burden
                    Number of respondents                           hours         Hourly wage       Total cost
                                                                  annualized          rate          annualized
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26...........................................................             100             $150         $390,000
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    The average to industry per hour for this type of work is $150, 
resulting in a cost of $15,000 per respondent. The estimated submission 
cost of $15,000 multiplied by 26 submissions per year equals $390,000, 
which is the aggregated industry reporting cost annualized.
    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 to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

    Dated: September 27, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-25367 Filed 9-30-11; 8:45 am]
BILLING CODE 4160-01-P


