[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41413-41415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Medical Devices: The Pre-Submission Program and Meetings With 
FDA 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availability of the draft guidance entitled ``Medical Devices: The Pre-
Submission Program and Meetings with FDA Staff.'' The purpose of this 
guidance is to describe the Pre-Submission program (formerly the pre-
Investigational Device Exemption (IDE) program) for medical devices 
reviewed in the Center for Devices and Radiological Health (CDRH) and 
the Center for Biologics Evaluation and Research (CBER). In addition, 
the guidance provides recommendations regarding information that should 
be included in a Pre-Submission Package. This guidance also describes 
the procedures that CDRH and CBER intend to follow when industry 
representatives or application sponsors request a meeting with review 
staff. This draft guidance is not final nor is it in effect at this 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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 11, 2012. Submit either written or electronic 
comments on this collection of information by September 11, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Medical Devices: The Pre-Submission 
Program and Meetings with FDA Staff'' 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 Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, 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:

Angela Krueger, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, 
Silver Spring, MD 20993-0002, 301-796-6380; 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: 

I. Background

    Since its establishment in 1995, the pre-IDE program has been a 
successful resource for both medical device applicants and the FDA. 
Originally, this program was designed to provide applicants a mechanism 
to obtain FDA feedback on future IDE applications prior to their 
submission. Over time, the pre-IDE program evolved to include feedback 
on other device submission program areas, such as Premarket Approval 
(PMA) applications, Humanitarian Device Exemption (HDE) applications, 
and Premarket Notification (510(k)) Submissions, as well as to address 
questions related to whether a clinical study requires submission of an 
IDE. The purpose of this guidance is to update the pre-IDE program to 
reflect this broader scope and make important modifications to reflect 
changes in the premarket program areas as a result of the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85). This 
guidance also broadens the scope of the program to include those 
devices regulated by CBER. Accordingly, FDA is changing the name for 
this program from the pre-IDE program to the Pre-Submission (Pre-Sub) 
program.
    The main purpose of the Pre-Sub program remains the same as the 
pre-IDE program: to facilitate providing advice to applicants when they 
have specific questions during product development and early protocol

[[Page 41414]]

planning, about device studies that present significant risk(s) (SR) as 
well as non-significant risk(s) (NSR) or when developing protocols for 
clinical studies conducted outside of the United States to support 
future U.S. marketing applications (Ref. 1). Consequently, the Pre-Sub 
program can provide an efficient path from device concept to market 
while facilitating the Agency's goal of meeting FDAAA and Medical 
Device User Fee Act of 2008 (MDUFA II) review milestones.
    The Pre-Sub program has also faced several challenges, and the 
guidance is intended to address these challenges and improve the Pre-
Sub program by: (1) Describing the types of information that FDA would 
recommend submitting in order to get the best possible feedback from 
FDA; (2) outlining the process by which FDA meetings should be 
scheduled; and (3) explaining the Agency's expectations regarding 
advice given during the Pre-Sub process.
    This guidance outlines clear recommendations for sponsors and for 
FDA staff and managers as well as expected timeframes for scheduling 
meetings. FDA intends to provide the best possible advice in accordance 
with the information provided, ensure it is captured accurately in the 
meeting minutes drafted by the sponsor, and commit to that advice 
unless the circumstances sufficiently change such that our advice is no 
longer applicable, such as when a sponsor changes the intended use of 
their device after we provide feedback. It is also our intention to 
hold timely meetings with appropriate staff and managers present, if 
resources permit. However, both our ability to provide advice and to 
hold timely meetings are dependent on our receiving the necessary 
information in advance of the meeting.
    In addition, this guidance also describes the procedures that CDRH 
and CBER intend to follow when industry representatives or application 
sponsors request a meeting with review staff, either as the preferred 
method of feedback in response to a Pre-Sub, or to discuss an existing 
regulatory submission. This guidance also recommends how to prepare for 
meetings with FDA staff. FDA plans to revise the document as necessary 
to reflect any MDUFA III agreements.

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 Medical 
Device Pre-Submissions and Meetings with CDRH and CBER Staff. 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. To receive ``Medical Devices: Pre-Submissions 
and Meetings with FDA Staff,'' you may either send an email 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 1677 to identify the guidance you are requesting. A 
search capability for all CDRH guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm; a search capability for all CBER 
guidance documents is available at  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents are also available at  http://www.regulations.gov.

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; 
Medical Devices: The Pre-Submission Program and Meetings With FDA Staff

    This draft guidance describes the Pre-Submission program for 
medical devices reviewed in CDRH and CBER. The guidance provides 
recommendations regarding the information that should be submitted in a 
Pre-Submission Package and procedures that should be followed for 
meetings between CDRH and CBER staff and industry representatives or 
application sponsors. When final, this document will supersede ``Pre-
IDE Program: Issues and Answers--Blue Book Memo D99-1'' dated March 25, 
1999.
    A Pre-Submission is defined as a formal written request from an 
applicant for feedback from FDA to be provided in the form of a formal 
written response or, if the manufacturer chooses, a meeting or 
teleconference in which the feedback is documented in meeting minutes. 
A Pre-Submission is appropriate when FDA's feedback on specific 
questions is necessary to guide product development and/or application 
preparation. The proposed collections of information are necessary to 
allow the Agency to receive Pre-Submission Packages in order to 
implement this voluntary submission program.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41415]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
  Submission of information for      Number of       Numer of      Total annual     burden per
     Pre-Submission Program         respondents    responses per     responses      respondent      Total hours
                                                    respondent                      (in hours)
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CDRH............................            2465               1            2465             137         337,705
CBER............................              79               1              79             137          10,823
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    Total.......................            2544               1            2544             137         348,528
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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 subject to FDA's laws 
and regulations. FDA estimates that it will receive approximately 2544 
pre-submission packages annually. The Agency reached this estimate by 
reviewing the number of submissions received by the Agency under the 
Pre-IDE program over the past 10 years. Based on FDA's experience with 
the Pre-IDE program, FDA expects the Pre-Submission program to continue 
to be utilized as a viable program in the future and expects that the 
number of pre-submission packages will increase over its current rate 
and reach a steady state of approximately 2544 submissions per year.
    FDA estimates from past experience with the Pre-IDE program that 
the complete process involved with the program takes approximately 137 
hours. This average is based upon estimates by FDA administrative and 
technical staff that is familiar with the requirements for submission 
of a Pre-Submission 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 
348,528 hours.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                 Total burden
                    Number of respondents                           hours         Hourly wage       Total cost
                                                                  annualized          rate          annualized
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2544.........................................................             137             $150      $52,279,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The average to industry per hour for this type of work is $150, 
resulting in a cost of $20,550 per respondent. The estimated submission 
cost of $20,550 multiplied by 2544 submissions per year equals 
$52,279,200, which is the aggregated industry reporting cost 
annualized.
    This draft guidance also refers to previously approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 803 are approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 807, subpart E is approved 
under OMB control number 0910-0120; and the collections of information 
in 21 CFR part 812 are approved under OMB control number 0910-0078.

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. 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.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see Comments) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Please see 21 CFR 812.3(m) and FDA's Web page on Clinical 
Trials, available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

    Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17078 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P