[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Notices]
[Pages 48170-48172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19360]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1279]


Pilot Program for Qualification of Medical Device Development 
Tools

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting proposals 
to participate in a pilot program for Medical Device Development Tools 
(MDDT) qualification (MDDT Pilot Program). Under the MDDT Pilot 
Program, FDA intends to work together with developers of tools that 
meet the criteria for the proposed program, to determine whether 
certain tools may be developed and qualified in order to facilitate 
more predictable, efficient, and transparent regulatory evaluation when 
MDDTs are used to generate valid scientific evidence for medical device 
premarket applications.

DATES: FDA will begin accepting nominations for participation in the 
voluntary MDDT Pilot Program September 15, 2014.

FOR FURTHER INFORMATION CONTACT: Joan Adams-White, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3650, Silver Spring, MD 20993-0002, 301-
796-5421, Joannie.Adams-White@fda.hhs.gov; or Kathryn O'Callaghan, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3614, Silver 
Spring, MD 20993-0002, 301-796-6349, Kathryn.ocallaghan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 14, 2013 (78 FR 68459), the 
Food and Drug Administration (FDA) announced the availability of the 
draft guidance entitled ``Medical Device Development Tools'' (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm374427.htm) (MDDT draft guidance). When finalized, 
the draft guidance will represent FDA's current thinking on 
qualification of MDDTs for use in device development and evaluation. 
The proposed MDDT qualification process is intended to support the 
development of MDDTs--tools that manufacturers and FDA use to assess 
and measure the performance,

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safety, and effectiveness of medical devices. MDDT tools qualified by 
FDA can then be relied upon by the medical device industry in support 
of their device submissions to the Agency, potentially reducing time 
and other resources needed to develop new products. This proposed 
voluntary qualification process is intended to enable submitters of 
MDDT proposals chosen for this pilot program to work closely with FDA 
to determine the amount and type of evidence and other information 
needed to support qualification for a specific tool and context of use.
    The anticipated benefits of the proposed MDDT qualification process 
include facilitating timely development of tools that manufacturers and 
FDA use to assess and measure the performance, safety, and 
effectiveness of medical devices. FDA expects that manufacturers can 
better rely on MDDTs that have been FDA reviewed and accepted 
(qualified), and made available through this voluntary program, which 
supports innovative medical device development and promotes regulatory 
science. The proposed MDDT qualification process supports the FDA's 
plan to advance regulatory science--the science of developing new 
tools, methods and approaches to assess the safety, effectiveness, 
performance, and quality of medical devices. Advancements in regulatory 
science help to bridge the gap between research and discovery of 
medical devices and the actual delivery of the device to patients. The 
proposed qualification process also supports FDA's strategic priority 
of strengthening the clinical trial enterprise by potentially 
increasing the efficiency of the clinical studies. Finally, this 
proposed qualification process supports FDA's strategic priority 
actions to strike the right balance between premarket and postmarket 
data collection, leading to earlier access to beneficial innovative 
technologies for patients in the United States. For example, an MDDT 
qualified for use as an intermediate or surrogate endpoint could 
facilitate more efficient development and evaluation of devices, 
especially for those intended to address unmet medical needs.
    FDA is proposing a new voluntary MDDT Pilot Program. Information 
learned and experiences gained from the MDDT Pilot Program will help 
inform the final guidance document and processes. FDA plans to 
prioritize proposals based on public health need or potential to impact 
multiple device development programs. Additionally, for the purposes of 
the pilot, proposals are expected to be prioritized based on 
feasibility, timeline, and FDA resources. See section II.B. Appropriate 
Candidates, for details.

II. MDDT Pilot Program

    FDA has developed a pilot program for interested tool developers. 
This document outlines: (1) The guiding principles underlying the MDDT 
Pilot Program, (2) appropriate candidates for the MDDT Pilot Program, 
and (3) the procedures FDA intends to follow in the MDDT Pilot Program.

A. Guiding Principles

    The following basic principles underlie the MDDT Pilot Program 
described in this document. FDA intends that these principles create a 
common understanding between the submitter and FDA about the goals and 
parameters of the MDDT Pilot Program:
    1. For qualified MDDTs, FDA intends to make public the context of 
use, summary of evidence, and basis of the qualification determination 
(analogous to summaries of approved devices). FDA will keep proprietary 
information confidential. Submitters must consent to make MDDTs 
accessible to the public for use (e.g. through sales, open source, 
etc.), and not restrict to certain private entities, such as a single 
manufacturer.
    2. FDA and the MDDT Pilot Program places no requirements on 
licensing/cost/degree of access to intellectual property associated 
with a tool, nor does it consider restrictions related to patent 
claims. An MDDT submitter may include and protect proprietary methods 
as long as access to the tool is not restricted to certain private 
entities.
    3. Participating in this MDDT Pilot Program does not guarantee 
qualification of an MDDT, nor is a submitter precluded from withdrawing 
from the MDDT Pilot Program.
    4. Due to FDA resource constraints, FDA intends to limit the MDDT 
Pilot Program to no more than 15 candidates.

B. Appropriate Candidates

    The process for MDDT qualification can be initiated in one of three 
ways: (1) A tool developer chooses to pursue qualification for his or 
her tool to allow for use across multiple device development programs; 
(2) need and interest in an area is determined by individual or 
consortia of stakeholders (may include academia, industry, medical 
societies); or (3) FDA identifies an area of need and calls for 
development of tools in a specific area.
    Appropriate candidates for the MDDT Pilot Program are:
    1. Tools which fit into one of the following categories:
     Clinical Outcome Assessments such as patient-reported 
outcomes or clinical outcomes based on clearly defined subjective 
clinical decision making as a measure of treatment benefit;
     Biomarker Tests such as in vitro laboratory tests or 
medical imaging methods, or other objective measurement methods used to 
detect or measure a biomarker; or
     Nonclinical Assessment Models such as in vitro (``bench'') 
models, animal models, or computer models to measure a parameter of 
interest or to substitute for another generally accepted test or 
instrument.
    2. Tools which address the following factors:
     Public health need met by one or more of the following:
    [cir] Context of use includes life-threatening or serious chronic 
diseases/conditions, or both;
    [cir] No/poor alternatives or unmet scientific need;
    [cir] Innovative technology with no established paradigm for 
regulatory assessment; or
    [cir] Gain major efficiencies in device development and evaluation 
time.
     Scope of impact:
    [cir] Potential to impact multiple device development programs; or
    [cir] Potential to impact multiple device sponsors.
    3. FDA intends to prioritize candidates for the pilot program based 
on the following factors:
     Tool readiness: Does the tool exist in prototype or final 
form?
     Acceptance of proposed context of use: Does available 
information support acceptance of the tool principle/method of 
measurement for the proposed context of use, or for any use?
     Timeline: What is the expected timeline to submission of a 
qualification package?
     Potential for public health impact: Does the tool address 
an unmet public health need or significantly reduce product development 
timelines, or both?
    FDA encourages any interested developers who believe their tool is 
an appropriate candidate for the MDDT Pilot Program to contact FDA 
before initiating the procedures referenced under the following section 
titled ``Procedures.''

C. Procedures

    FDA has developed the following procedures to ensure adequate 
information to assess a candidate's suitability for the MDDT Pilot 
Program is provided to FDA without creating a burdensome new 
application process:
    1. Nomination. The submitter may nominate his or her tool for

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participation in the MDDT Pilot Program by submitting a proposal to 
MDDT@fda.hhs.gov. FDA intends to acknowledge receipt of nominations via 
email.
    A submitter's proposal for the MDDT Pilot Program should include 
the following information to assist FDA in processing and responding to 
nominations:
     A cover letter and a brief statement explaining why the 
tool is an appropriate candidate for the MDDT Pilot Program as 
described under section II., B. Appropriate Candidates; and
     A description of the tool, the proposed context of use, a 
synopsis of the available evidence and plans for additional evidence 
gathering, and an assessment of the advantages or disadvantages related 
to the capabilities and limitations of the tool for the proposed 
context of use.
    2. Submitter Notification. FDA intends to notify the submitter via 
email whether or not the tool is an appropriate candidate for the MDDT 
Pilot Program within approximately 30 days of receipt of the complete 
information.
    3. Pre-qualification Plan. If the nominee is deemed an appropriate 
candidate, the submitter will be notified by FDA and invited to submit 
a pre-qualification plan within approximately 30 days of being notified 
by the FDA that its nominee was accepted. One way to present the pre-
qualification plan is included in Appendix 1 of the MDDT draft 
guidance. FDA recommends the pre-qualification and qualification plans 
be submitted in accordance with FDA guidance entitled ``Medical 
Devices: Pre-Submission Program and Meetings with FDA Staff'' 
(www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf) as the process for the MDDT pilot 
program is expected to be modeled after the Pre-Submission Program.
    4. Pre-qualification Meeting. FDA intends to meet with the 
submitter, either in person or by phone, in accordance with the process 
outlined in the FDA guidance on ``Medical Devices: Pre-Submission 
Programs and Meetings With FDA Staff.'' The qualification review team 
(which may include FDA as well as external expertise, where 
appropriate) will interact with the submitter to identify the amount 
and type of data or information needed for qualification of the tool 
for the proposed context of use.
    5. FDA Review. Under the MDDT Pilot Program, the Agency intends to 
work interactively with submitters as follows:
     Where appropriate, FDA may seek input from external 
individuals or groups for specific expertise, consistent with all 
applicable statutory and regulatory requirements, including those 
respecting confidentiality.
     During the process for MDDT qualification, FDA intends to 
interact with submitters to efficiently determine the amount and type 
of information needed to support qualification for a specific tool and 
context of use, and as needed for clarification or to request 
additional information.
     When the submitter has the data and information necessary 
for a complete qualification package, they may submit it to justify 
qualification of the tool for the proposed context of use. FDA intends 
to hold a qualification meeting or teleconference to facilitate 
discussion once the package has been reviewed.

D. Duration of the MDDT Pilot Program

    FDA intends to accept requests for participation in the MDDT Pilot 
Program until such time that the MDDT draft guidance is finalized. FDA 
may decide to terminate the MDDT Pilot Program at any time or extend 
the MDDT Pilot Program. The decision to terminate or extend the MDDT 
Pilot Program will be announced in the Federal Register. FDA may also 
decide to modify the MDDT Pilot Program while it is in effect. Any 
significant modifications will also be announced in the Federal 
Register.

E. Evaluation

    FDA intends to use the experience gained from the MDDT Pilot 
Program to inform the final version of the MDDT guidance and processes.

III. Paperwork Reduction Act of 1995

    This notice contains information collection that is 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 part 812 have been approved under OMB control 
number 0910-0078 (Investigative Device Exemption); the collections of 
information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231 (Premarket Approval); the collections of information 
in 21 CFR part 807, subpart E have been approved under OMB control 
number 0910-0120 (Premarket Notification); and the collections of 
information in 21 CFR part 809 have been approved under OMB control 
number 0910-0485.

    Dated: August 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19360 Filed 8-14-14; 8:45 am]
BILLING CODE 4164-01-P