De Novo Classification Process (Evaluation of Automatic Class III Designation); Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 47651-47653 [2014-19253]
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Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
products. The 2009 draft guidance
provided guidance on the Clinical
Pharmacology section of the
prescription drug labeling under the
PLR.
tkelley on DSK3SPTVN1PROD with NOTICES
II. Revised Draft Guidance
FDA is announcing the availability of
a draft guidance entitled ‘‘Clinical
Pharmacology Labeling for Human
Prescription Drug and Biological
Products—Considerations, Content, and
Format,’’ which is a revision of the 2009
draft guidance. The revised draft
guidance provides clarifications of
recommendations in the 2009 draft
guidance based on consideration of
public comments on the 2009 draft
guidance and the Agency’s increased
regulatory experience implementing the
PLR. This draft guidance provides
clarity on the information that should be
included in section 12 Clinical
Pharmacology and provides guidance
on the inclusion of clinical
recommendations based on clinical
pharmacology findings in other sections
of the labeling.
A. Clinical Pharmacology Section of
Labeling
The draft guidance is intended to
assist applicants in preparing the
Clinical Pharmacology section of
product labeling to meet the
requirements of FDA regulations (21
CFR 201.57(c)(13)). The draft guidance
is also intended to ensure consistency,
as appropriate, in labeling of the
Clinical Pharmacology section for all
prescription drug products approved by
FDA.
The draft guidance outlines the use of
subsections, headings, and subheadings
to provide organization to the Clinical
Pharmacology section. The draft
guidance also emphasizes the
importance of providing variability
measures related to pharmacokinetic
measures and parameters,
pharmacodynamic measures, and other
clinical pharmacology study results.
This draft guidance provides a general
framework and set of recommendations
that should be adapted to specific drugs
and their conditions of use. Not all of
the information identified in this draft
guidance for inclusion in the Clinical
Pharmacology section of product
labeling will be applicable for every
drug. For the purposes of this notice, all
references to drugs include both human
drugs and biological products unless
otherwise specified.
B. Cross-Referencing of Clinical
Pharmacology Information
Detailed information on clinical
pharmacology topics is included in the
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Clinical Pharmacology section, while
other sections of labeling contain
summary information and clinical
recommendations that may be related to
clinical pharmacology information.
Optimal pharmacotherapy is driven by
an understanding of a drug product’s
clinical pharmacology as well as the
clinical context in which the drug will
be used. Important clinical
pharmacology attributes to consider in
therapeutic decisionmaking include, but
are not limited to, drug mechanism of
action, pharmacodynamic effects (e.g.,
on target, on pathway, and off target/
pathway), and pharmacokinetic
properties in a variety of settings and
specific populations. Clinical
pharmacology information collected
throughout a drug product’s life can
contribute to the product’s labeling.
Specifically, FDA considers what
clinical pharmacology information can
be directly translated to patient care
management and provides specific
recommendations that should be
included in relevant sections of the
labeling. Examples include strategies for
dose selection, therapeutic
individualization, and adverse reaction
risk minimization. In these cases,
supportive information (i.e., the clinical
pharmacology basis for the specific
recommendation) is expected to be
concise to enable unambiguous
application to patient care.
Occasionally, depending on the
complexity of the patient care
recommendations, it can be appropriate
to provide expanded versions of this
supportive information in the labeling.
The reason for including this
information is to provide sufficient
detail for the health care provider to
determine the relevance of the
information for a given patient or
clinical scenario; this information is
typically included in the Clinical
Pharmacology section of product
labeling and is the main focus of the
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 inclusion of clinical pharmacology
information in section 12 Clinical
Pharmacology of product labeling. 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 requirement
of the applicable statutes and
regulations.
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47651
III. Paperwork Reduction Act of 1995
This revised draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572;
the collections of information related to
pharmacogenomic data have been
approved under OMB control number
0910–0557.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19264 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘De Novo Classification Process
SUMMARY:
E:\FR\FM\14AUN1.SGM
14AUN1
tkelley on DSK3SPTVN1PROD with NOTICES
47652
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
(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 https://
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
VerDate Mar<15>2010
16:42 Aug 13, 2014
Jkt 232001
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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
E:\FR\FM\14AUN1.SGM
14AUN1
47653
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
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
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:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Submission of information for de novo classification
program
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
respondent
(in hours)
Total hours
CDRH (21 U.S.C. 513(f)(2)(i)) .............................................
CBER (21 U.S.C. 513(f)(2)(i)) ..............................................
CDRH (21 U.S.C. 513(f)(2)(ii)) ............................................
CBER (21 U.S.C. 513(f)(2)(ii)) .............................................
25
1
25
1
1
1
1
1
25
1
25
1
100
100
180
180
2,500
100
4,500
180
Total ..............................................................................
........................
........................
........................
........................
7,280
tkelley on DSK3SPTVN1PROD with NOTICES
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
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16:42 Aug 13, 2014
Jkt 232001
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.
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 https://
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
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
PO 00000
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E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov or https://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\
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 7,280
----------------------------------------------------------------------------------------------------------------
\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 https://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 https://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
