[Federal Register Volume 76, Number 191 (Monday, October 3, 2011)]
[Notices]
[Pages 61103-61105]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``De Novo Classification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 FDA is issuing this draft guidance to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 This draft guidance is not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draft guidance before it begins work on the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comments on the draft guidance by December 2, 2011.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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``De Novo Classification Process (Evaluation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
[email protected] 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
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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]
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