Contains Nonbinding Recommendations 
Qualification of Medical Device 
Development Tools 
Guidance for Industry, Tool 
Developers, and Food and Drug 
Administration Staff 
Document issued on July 17, 2023. 
Document originally issued on August 10, 2017. 
This document supersedes Qualification of Medical Device Development Tools: 
Guidance for Industry, Tool Developers, and Food and Drug Administration 
Staff issued August 10, 2017. 
For questions about this document, contact the Medical Device Development Tools program by e-
mail at MDDT@fda.hhs.gov.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2013-D-1279. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number GUI00001882 and complete title of the guidance in the request. 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
I.  Introduction .............................................................................................................................1 
 
II.  Definition of Key Concepts ....................................................................................................2 
 
III.  Overview .................................................................................................................................4 
 
A.  What is an MDDT & MDDT qualification? ........................................................................4 
B.  Why is the MDDT qualification beneficial? ........................................................................5 
C.  How could MDDTs be used in device evaluation and regulatory decision-making? ..........6 
 
IV.  CDRH Qualification Decision Framework .............................................................................7 
 
A.  Proposal Phase .....................................................................................................................7 
B.  Qualification Phase ............................................................................................................10 
C.  Potential Changes to Qualification Status..........................................................................12 
D.  Regulatory Considerations and Related Recommendations ..............................................12 
 
V.  Communication to Public of FDA Qualification Decisions .................................................14 
 
 
  Contains Nonbinding Recommendations 
 
 
Qualification of Medical Device 
Development Tools 
  
 
Guidance for Industry, Tool 
Developers, and Food and Drug 
Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
 
This document provides guidance on a voluntary program for qualification of medical device 
development tools (MDDTs) for use in evaluating devices subject to regulation by Center for 
Devices and Radiological Health (CDRH). CDRH believes that this policy will facilitate the 
development and timely evaluation of medical devices, by providing a more efficient and 
predictable means for collecting the necessary information to support regulatory submissions and 
associated decision-making.  
 
The purpose of this guidance is to describe the framework for voluntary proposal and 
qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an 
MDDT for a specific context of use, considerations for qualification, and the contents of a 
qualification package. For purposes of this guidance, a submitter is a person, group, consortium, 
or organization (including the federal government) that takes responsibility for and initiates the 
MDDT qualification process using the procedures described in this guidance. 
 
This guidance does not discuss the review of MDDTs (also referred to as tools in this 
guidance) that are submitted in individual premarket regulatory submissions for use with a 
particular medical device, nor does it address the specific evidentiary or performance 
expectations for the qualification of an individual MDDT submission.   
 
In general, FDA's guidance documents, including this guidance, do not establish legally 
enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
1  Contains Nonbinding Recommendations 
 
 
requirements are cited. The use of the word should in Agency guidances means that something is 
suggested or recommended, but not required. 
 
II.  Definition of Key Concepts 
 
For the purposes of this guidance, the following definitions apply and are consistent with the 
recent Biomarkers, Endpoints, and other Tools (BEST) resource.1 This section includes brief 
definitions followed by examples and other explanatory information about the terms.  
 
  Medical Device Development Tool (MDDT) is a method, material, or measurement 
used to assess the safety, effectiveness, or performance of a medical device. An MDDT is 
scientifically substantiated and can be qualified for use in device evaluation and to 
support regulatory decision-making within a specified context of use.   
 
  Context of Use (COU) is a statement that fully and clearly describes the way the MDDT 
is to be used and the medical device development-related purpose of the use.  
 
  Performance Criteria are objective performance measures of the MDDT outlined in the 
qualification plan that describe how the tool can be considered as suitable within the 
proposed context of use. Performance criteria may include, for example, measures of the 
proposed tools consistency (across different sites and operators), accuracy and 
sensitivity. The performance criteria should be accompanied by acceptance criteria that 
outline when the performance criteria are satisfied and when the tool can be relied upon 
for regulatory decision making.  
 
  Proposal Package is the initial MDDT submission or MDDT Proposal where the MDDT 
submitter provides the tool description, regulatory utility (how the tool supports safety, 
effectiveness, or performance of a medical device in a regulatory submission), 
qualification plan, and performance criteria to describe the expected performance of the 
tool. 
 
  Qualification Package is the documented evidence, following the proposed qualification 
plan, comparing the actual performance of the proposed MDDT to the performance 
criteria detailed in the Proposal.  
 
  Qualification is a conclusion based upon FDA review of the MDDT Qualification 
Package. A qualification decision signifies that the MDDT can be relied upon to facilitate 
regulatory decision making when it is used according to the qualified COU. 
 
 
1 The qualification definition in this guidance is consistent with the BEST definition. See BEST (Biomarkers, 
EndpointS, and other Tools) Resource; Glossary, https://www.ncbi.nlm.nih.gov/books/NBK338448/. 
2  Contains Nonbinding Recommendations 
 
 
In general, MDDTs can be categorized into three types, distinguished primarily by how the tool 
measures relevant parameters: Non-clinical Assessment Models (NAMs), Biomarker Tests 
(BTs),2 and Clinical Outcome Assessments (COAs).3  
 
1.  A Non-clinical Assessment Model (NAM) is a non-clinical test model or method that 
measures or predicts parameters of interest in regard to device safety, effectiveness, or device 
performance. 
 
Examples of NAMs include:  
  human or animal-based models to replace clinical testing; 
  in vitro models to replace animal testing; 
  tissue and other material phantoms to evaluate imaging or other devices; and 
  physics-, chemical- or biological- based computational models.  
 
Qualified NAMs may be used to evaluate a new material property, modifications to an 
existing design, or a device feature historically evaluated through other bench, animal, or 
human testing.    
 
2.  A Biomarker Test (BT) is a test or instrument used to detect or measure a biomarker.   
 
Reliable biomarkers can help reduce uncertainty during device development and evaluation 
by providing predictions about device performance. BTs used to measure biomarkers in 
patients before treatment can be used to select patients for inclusion in a clinical trial. BTs 
used to detect changes in biomarkers following treatment may predict or identify safety 
problems related to a therapeutic device or reveal the response to an intervention expected to 
predict clinical benefit from treatment.  
 
It is important to note that a BT being considered for qualification is conceptually 
independent of the biomarker (e.g., sphygmomanometer vs. blood pressure). A biomarker, 
however, cannot be qualified without a reliable means to measure it. In assessing BTs for 
qualification, CDRH will evaluate both the strength of evidence supporting the biomarker for 
the specified COU, as well as the performance characteristics of the test(s) used to provide 
the biomarker data. Test validity (e.g., precision and accuracy) should be demonstrated for 
the proposed COU.4  
 
 
2 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.biomarker/ 
3 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.clinical-outcome-assessment/ 
4 The amount and type of new evidence needed to support qualification of a BT may also depend in part on whether 
there is any test or instrument for measurement of the biomarker that is already FDA cleared or approved for clinical 
use through premarket review, and if so, whether the proposed COU for the BT is consistent with the indication for 
use of the cleared or approved device. To qualify a BT to measure a biomarker for which there is no corresponding 
FDA cleared or approved device, test performance characteristics (e.g., precision and accuracy) should be 
demonstrated for the proposed COU.  In contrast, MDDT qualification proposals involving an FDA cleared or 
approved test, or involving biomarkers for which FDA has established the analytical performance criteria necessary 
for measurement for the specified COU, can make use of existing data that support the analytical validity of the test, 
so long as the MDDT submitter is legally authorized to do so. In either case, qualification depends on meeting 
performance criteria for the test as an MDDT for the proposed COU. 
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3.  A Clinical Outcome Assessment (COA) describes or reflects how a person feels, functions, 
or survives and can be reported by a health care provider, a patient, a non-clinical observer 
(such as a parent), or through performance of an activity or task. COAs could be collected in 
the clinic or remotely (e.g., collected with the use of digital health technologies). 
 
A COA includes not only the measure that produces a score, but also the clearly defined 
methods and instructions for administering the tool, a standard format for data collection, and 
well-documented methods for scoring, analysis, and interpretation of results in the targeted 
patient population. COAs can measure treatment benefit directly or indirectly (e.g., a diary of 
rescue pain therapy used for pain intensity).   
 
The four common types of COAs are patient-reported outcome (PRO) measures,5 clinician-
reported outcome (ClinRO) measures,6 observer-reported outcome (ObsRO) measures,7 and 
performance outcome (PerfO) measures.8 Other COAs used as a measure of patient benefit, 
safety, may be qualified as MDDTs. 
 
III.  Overview 
 
A.  What is an MDDT & MDDT qualification? 
 
An MDDT is a method, material, or measurement used to assess the safety, effectiveness, or 
performance of a medical device. An MDDT is scientifically substantiated and can be qualified 
for use in device evaluation to support regulatory decision-making. Examples of MDDTs 
are non-clinical assessment models (NAMs), biomarker tests (BTs), and clinical 
outcome assessments (COAs). The use of a qualified MDDT by a medical device manufacturer 
is voluntary.  
 
Qualification is a conclusion based upon FDA review of the MDDT Qualification Package. 
Qualification reflects CDRHs expectation that, within a specified context of use (statement that 
describes the conditions and boundaries within which the MDDT has been qualified for use), the 
results of an assessment that uses an MDDT can be relied upon in device evaluation and to 
support regulatory decision-making. In brief, qualification is a voluntary process to establish the 
scientific rigor associated with an MDDT for a specific use in supporting regulatory decision-
making. 
 
The intent of this voluntary CDRH MDDT program is to promote the development and use of 
MDDTs to streamline device development and regulatory evaluation. Once an MDDT is 
qualified for a specific COU, CDRH encourages MDDT developers to make their qualified 
MDDT(s) publicly available, which can include under a licensing arrangement, so that the 
MDDT(s) can be used by any medical device manufacturer for the qualified COU. CDRH 
reviewers should accept the MDDT for the qualified COU without the need to reconfirm the 
 
5 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.patientreported-outcome/ 
6 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.clinicianreported-outcome/ 
7 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.observerreported-outcome/ 
8 https://www.ncbi.nlm.nih.gov/books/NBK338448/def-item/glossary.performance-outcome/ 
4  Contains Nonbinding Recommendations 
 
 
suitability and utility of the MDDT when used in a CDRH regulatory submission. CDRH review 
divisions maintain the responsibility for evaluating regulatory submissions using the totality of 
evidence in addition to the information obtained from a qualified MDDT. 
 
The existence of a qualified MDDT does not convey a requirement that the tool must be used 
during the device development or regulatory evaluation processes. Other scientifically valid tools 
or approaches may also be used. Moreover, the qualification of a tool does not prohibit the 
qualification of a similar tool with the same COU. 
 
The availability of qualified MDDTs that can be utilized by many medical device manufacturers 
is expected to aid in streamlining device development and regulatory evaluation. To advance 
these goals, FDA only intends to qualify tools where FDA can make public certain high-level 
information about the existence of qualified tools and their utility. FDA will not make public any 
proprietary information without permission from the MDDT developer. FDA communication 
related to qualified MDDTs is discussed in more detail in Section V below. 
 
B.  Why is MDDT qualification beneficial? 
 
Qualification, as described in this guidance, is intended to increase predictability in device 
evaluation and improve efficiency in regulatory decision-making by making it clear to medical 
device manufacturers that FDA accepts assessments from a qualified MDDT in support of 
demonstrating safety, effectiveness, or performance of a medical device, without need to 
reconfirm suitability and utility of the MDDT, when used within the qualified COU. 
 
Furthermore, the MDDT program provides a mechanism for leveraging advances in regulatory 
science. Advancements in regulatory science help bridge the gap between research and 
development of medical devices and the delivery of high quality, safe, and effective devices to 
patients. CDRH is committed to advancing regulatory science,  which provides the tools, 
standards, and approaches needed to evaluate the safety, effectiveness, and performance of the 
devices we regulate. Through continued advances, such as with the MDDT program, CDRH is 
modernizing the regulatory evaluation process and reducing the time and resources needed to 
develop and assess new medical devices.  
 
Qualification also facilitates tool development and adoption, including through collaboration in a 
non-competitive setting, where multiple interested parties (individuals/stakeholders, 
companies/consortia, or organizations) may work together and pool resources to expedite 
development, validation, and use of an MDDT. CDRH encourages the formation of consortia or 
other collaborations to foster MDDT development programs to increase the efficiency of tool 
development through joint efforts and to reduce the resource expenditure of any individual 
person or company. As further detailed in this guidance, stakeholders who wish to discuss 
developing an MDDT for potential qualification should contact FDA.  
 
Qualification also presents advantages for CDRH pertaining to review resources. Historically, if 
there was interest in using a particular tool to generate evidence in support of regulatory 
decisions, such as a PRO measure, each FDA device review team evaluated the data justifying 
the tool use for each regulatory submission on a case-by-case basis. With this program, the 
5  Contains Nonbinding Recommendations 
 
 
review of the tool and its relevant data takes place outside the review of the individual regulatory 
submission and instead, is reviewed during the MDDT qualification process. Once qualified, the 
tool can then be relied upon by FDA staff within the qualified COU, without further detailed 
review of the suitability of the MDDT. Stakeholders can find instructions for using a particular 
qualified MDDT in the publicly available qualification summary documentation (i.e., the 
MDDT Summary of Evidence and Basis of Qualification (SEBQ)) available at: 
https://www.fda.gov/medical-devices/medical-device-development-tools-mddt#mddts.     
 
C.  How could MDDTs be used in device evaluation and 
regulatory decision-making? 
 
MDDTs can be used in demonstrating safety, effectiveness, or device performance and to 
support regulatory decision-making by facilitating the efficient provision of supporting evidence 
in non-clinical or clinical settings. MDDTs may be used in a variety of ways to collect, evaluate, 
and/or predict bench or in vivo performance. In addition, MDDTs may have a variety of roles in 
a device clinical study such as patient selection, study population enrichment, monitoring 
treatment response, predicting or identifying safety problems related to treatment with a medical 
device or identifying patients who are or are not candidates for certain forms of therapy. 
Appropriate use of qualified MDDTs may increase the efficiency of the device development and 
evaluation process by providing reliable predictions about device performance or by identifying 
patients more likely to respond to treatment or experience disease progression in the near future. 
Some examples of the specific roles for MDDTs in device evaluation include: 
 
  to reduce test duration or minimize sample size, or replace a standardized non-clinical 
bench performance test, e.g., using as a computational model; 
  to replace an evaluation typically conducted in human studies with an evaluation done in 
animal or engineering models;  
  to reduce or minimize the use of animals, e.g., using a simulation, tissue scaffolds; 
  for selection of clinical study subjects; 
  to stratify patient population by predicted risk and/or effectiveness outcomes; 
  for study population enrichment; 
  for an intermediate endpoint measurement to support predictions for successful study 
outcomes;9, 11 
  to determine technical parameters to inform labeling to ensure patient safety (e.g., MRI 
Safety Information, toxicology); 
 
9 An intermediate endpoint is itself a clinical endpoint concerning a symptom or measure of function that is not the 
ultimate outcome of the disease. Improvement according to an intermediate endpoint is of value to patients even if 
this does not lead to reduced morbidity or mortality. An intermediate endpoint may also be a clinical endpoint 
measured at an earlier timepoint than has historically been accepted. A treatment effect shown by an intermediate 
endpoint may also be taken as reason to expect a favorable ultimate outcome; in this sense the intermediate endpoint 
plays the role of a surrogate. For example, exercise tolerance is sometimes used as an intermediate endpoint in trials 
of treatments for heart failure. 
6  Contains Nonbinding Recommendations 
 
 
  to develop a surrogate endpoint;10, 11  
  for remote monitoring and endpoint collection; 
  to provide standardized verification or validation tools for device algorithms or models; 
and 
  for developing post-market surveillance methodologies such as methods or models 
capturing real world outcomes. 
 
IV.  CDRH Qualification Decision Framework 
 
The voluntary qualification process consists of two phases, the Proposal Phase and Qualification 
Phase, which are described below.  
 
We recommend eCopy submission packages be submitted electronically via the CDRH 
Customer Collaboration Portal (CDRH Portal) as discussed in the following website:  
https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-
premarket-submissions-online-cdrh-portal. Once submitted via the CDRH Portal, the submission 
will be received by the CDRH Document Control Center (DCC). Alternatively, submission 
packages may be mailed to the CDRH DCC. The current mailing address for CDRHs DCC is 
provided on the eCopy Program for Medical Device Submissions webpage at 
https://www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-
medical-device-submissions. 
 
Use of the CDRH Premarket Review Submission Cover Sheet12 for submissions made to CDRH 
is highly recommended to facilitate correct login and prompt routing to the appropriate review 
group. Submissions for these requests should be identified as an MDDT in the cover letter. 
Note that MDDT proposals and qualification packages, previously tracked as Informational 
Meeting Q-Submissions, are now tracked with a universal tracking number (UTN). 
 
A.  Proposal Phase 
 
The goal of the proposal phase is an initial assessment to determine if the MDDT is suitable for 
qualification through the MDDT program. When determining whether to qualify a proposed 
MDDT, CDRH will first review the MDDT Proposal Package. The ability to review a proposal 
will depend on available FDA resources. Note that even if the tool is not yet fully developed, 
 
10 A surrogate endpoint is a measurement used in trials as a substitute for a clinical endpoint, and is expected to 
reflect clinical outcomes based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence.  For 
example, blood pressure measurements are sometimes used as endpoints in trials of antihypertensive therapeutics, as 
a surrogate for clinical endpoints of stroke, myocardial infarction, or mortality. 
11 Use of intermediate or surrogate endpoints may allow for smaller trials or shorter follow-up, or be easier to 
measure than traditional clinical outcomes of a disease or condition. Optimal conditions for using intermediate or 
surrogate endpoints include when the traditional endpoint is a rarely occurring event or delayed in its presentation 
(as in certain chronic diseases); when measurement of the endpoint is invasive, uncomfortable, costly, or easily 
confounded; or when the treatment effect is small, and therefore would require trials of impractical size in order to 
meet statistical significance. 
12 See Form 3514, https://www.fda.gov/media/72421/download 
7  Contains Nonbinding Recommendations 
 
 
CDRH intends to review proposals for these tools. If the proposal is accepted, CDRH will review 
the Qualification Package with the qualification data.  
 
Those interested in seeking qualification should begin by submitting a proposal. A complete 
Proposal Package should include the following: 
 
  MDDT Description 
  A description of the MDDT with sufficient detail for CDRH to understand the 
tool and how the tool is intended to support an assessment of safety, effectiveness, 
or performance to facilitate regulatory decision making. 
  The category of the MDDT (NAM, BT, COA) with appropriate explanation as 
described in Section IV.   
  A statement declaring if the proposed MDDT is a cleared or approved medical 
device. 
  A statement if the MDDT has been previously submitted to the MDDT Program 
or through the Drug Development Tool Program.13 
  A description of how the MDDT achieves the specified output. This could include 
schematics, photos, figures, engineering drawings, as well as labeling and 
instructions for use.  
 
  Context of Use (COU) 
The COU is a key aspect of qualification. The amount and strength of evidence needed to 
support qualification depends largely on the defined COU. 
 
Once an MDDT is qualified, the COU defines the boundaries within which the available 
data adequately support use of the MDDT. 
 
The COU should describe the specific role of the MDDT in device development. A 
complete COU should include the following: 
 
  What the MDDT is intended to measure or assess (i.e., input and output of the 
tool). 
  How the tool is intended to be used, by whom, and the role of the MDDT in 
regulatory evaluation (e.g., for use in clinical studies, this includes the study 
population or disease characteristics, as well as specific use  diagnosis, patient 
selection, study endpoints). 
  The phase(s) of medical device development in which tool measurements can be 
used (e.g., design evaluation, animal testing, early clinical study, pivotal clinical 
studies to support market application, post-market study, or changes). 
  The limitations and constraints to the applicability of the tool (e.g., intended 
population, input parameters, environment of use). 
 
 
13 https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-
programs 
8  Contains Nonbinding Recommendations 
 
 
Since the COU is central to the appropriate use of the MDDT, we recommend that the 
COU be conveyed prominently when a tool developer offers its MDDT to medical device 
manufacturers. 
 
  Performance criteria  
  The performance criteria for the MDDT should be objectively defined (where 
possible). The performance criteria should be accompanied by acceptance criteria 
that outline when the performance criteria are satisfied and when the tool can be 
relied upon for regulatory decision making.  
 
  Qualification Plan  
  The MDDT submitter should provide a complete plan for collecting evidence to 
demonstrate that the tool reliably and accurately meets its intended purpose.  
  The qualification plan should include information and protocols describing how 
each performance criterion will be addressed. 
 
  Assessment of advantages and limitations (see Section IV.B for additional details) 
  For the proposed COU and plan for evidence generation, the advantages and 
limitations around tool use should be identified.  
  The advantages should highlight the impact of tool use in support of regulatory 
decision making.  
  The limitations should accurately detail the conditions under which the tool 
should not be used or may not provide a meaningful assessment of safety, 
effectiveness, or performance of a medical device.  
 
The advantages and limitations may be further refined in the Qualification Phase, after a 
review of the evidence. 
 
CDRH plans to review proposals with strong potential to meet a public health need and facilitate 
regulatory decision making. Each of the following include factors that would weigh in favor of 
the regulatory utility of the tool: 
 
  MDDT provides a safety, effectiveness, or performance assessment of medical devices 
intended for life-threatening and/or serious diseases or conditions, underserved 
populations such as pediatric patients, or to promote and advance health equity. 
 
  MDDT provides a safety, effectiveness, or performance assessment for novel or 
innovative technology with no established paradigm for regulatory assessment. 
 
  MDDT provides an assessment where there are no/poor alternatives or an unmet 
scientific need (e.g., no consensus standards or established methods). 
 
  Use of the MDDT allows for safer or less invasive, easier, more convenient, or less 
variable measurements than the alternative. 
 
9  Contains Nonbinding Recommendations 
 
 
  Use of the MDDT has the potential to impact multiple device development programs. 
 
For proposals that potentially meet one or more of the above factors, CDRH intends to notify 
MDDT submitters of its decision regarding proposal acceptance in writing approximately 90 
days from receipt of the proposal. For proposals that are accepted, CDRH intends to recommend 
suitable next steps for the submission (e.g., request for revision, advance to qualification). For 
those proposals not accepted, CDRH plans to also provide the factor(s) contributing to this 
decision.  
 
B.  Qualification Phase 
 
The goal of the qualification phase is to determine whether, for a specific COU, the tool is 
qualified based on the evidence provided. CDRH intends to review the evidence submitted in the 
Qualification Package in support of the proposed COU, and determine whether that evidence 
meets the performance criteria and supports the agreed upon Qualification Plan that was defined 
in the accepted MDDT Proposal. If the performance of the tool does not meet the performance 
criteria, then CDRH may make a determination to not qualify the tool, or may recommend a 
change to the COU within which the tool can be used to support regulatory decision-making. A 
complete Qualification Package should include: 
 
  MDDT Description (as described above in Section IV.A). 
 
  COU (as described above in Section IV.A). 
  The COU may be further refined during the Qualification Phase, based upon the 
review of the evidence submitted in support of the MDDT. 
 
  Qualification Plan with all descriptive elements and protocols (as described above in 
Section IV.A). 
 
  Tool Evidence:  
The amount and strength of evidence needed to support qualification of an MDDT will 
vary depending on the COU and the tool type. For example, an MDDT proposed for use 
for a specific medical device may need less data than a tool for use across different 
device types. The latter use may need more evidence of its validity due to the broader 
applicability or due to potential limitations of accepting an inaccurate MDDT. Submitters 
should explain how the strength of evidence for use of the MDDT is adequate to support 
the proposed COU. Evidence may include performance characteristics of the tool that 
would affect the usefulness of an MDDT, such as:  
 
  Tool Performance Characteristics: This evidence should demonstrate that the 
tool provides accurate and precise measurements. Sufficient data should be 
provided to adequately describe performance characteristics of the tool. 
Depending on the tool type, this evidence may include analytical, clinical, 
construct validity, external validity, reduction of bias, verification of the 
constitutive model, uncertainty quantification, and/or numerical convergence.  
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The type of evidence needed will vary depending on the tool type and COU and 
may include (but is not limited to): 
  design verification; 
  simulation results from computational models; 
  bench performance data (including full test reports and protocols); 
  animal performance data (including full test reports and protocols); 
  clinical data (including full test reports, protocols, and all appropriate (pre-
specified) statistical analyses to demonstrate the relationship between the 
tool and the COU); 
  human factors testing; and/or 
  literature articles (the full text article, a summary and a description of how 
the article supports qualification). 
 
  Reliability and Reproducibility: This evidence should describe the degree to 
which the tool measurement is related to the outcome of interest. This should 
include evidence on the strength of that relationship and that the outcome of 
interest is repeatedly demonstrated in multiple studies or as a class effect.   
 
  Assessment of Advantages and Limitations of Qualification 
   
When assessing advantages and limitations, CDRH intends to consider the following 
factors:  
 
  Assessments of Advantages of Using the MDDT:   
 
  Type of advantage(s). Advantages may include: significantly accelerating 
the time to develop and evaluate devices; allowing for shorter or smaller 
clinical or non-clinical studies; allowing for safer or less invasive, easier, 
more convenient, or less variable measurements than the alternative; and 
expediting the development of a novel technology of public health 
importance. 
 
  Magnitude of advantage(s). This may include: whether there is a 
potential to impact multiple device development programs; whether the 
COU addresses safety, effectiveness, or performance assessment of 
devices intended for life-threatening and/or serious chronic diseases or 
conditions, diseases/conditions where there are no or poor alternatives, 
underserved populations such as pediatric patients, or addresses health and 
healthcare disparities; or whether the MDDT is to be used for novel 
technology where there is no established paradigm for regulatory 
assessment. 
 
  Assessments of Limitations of Using the MDDT:   
 
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  Type of limitation(s). This includes an assessment of the conditions under 
which the performance of the tool is outside the performance criteria and 
the tool should not be applied or relied on for regulatory decision making.  
 
  Magnitude of limitation(s). The scope of impact of making a decision 
based on inaccurate conclusions from a MDDT is based on the severity of 
risk, a comparison of the MDDT to its alternatives, and considering the 
COU.  
 
  Likelihood of limitation(s). CDRH will consider how likely a particular 
risk is to occur. This could be based on the evidence in support of tool 
validity. For example, for a BT, this could be the likelihood of the MDDT 
reporting a false positive, false negative or false estimate of predictive 
value. 
 
  Mitigation of limitation(s). The use of mitigations may minimize the 
risks of relying on the MDDT. For example, alternative complementary 
sources of information or confirmatory data from later time points may 
mitigate risks of decision-making based on information from an MDDT. 
 
  Summary of Evidence and Basis of Qualification (see Section V) 
 
CDRH plans to review the qualification package based on the decision framework described in 
Section IV. CDRH intends to qualify the MDDT if the tool is adequately described, the proposed 
COU is appropriately defined, the strength of evidence supports use of the MDDT within the 
proposed COU, and the probable advantages of using a tool outweigh the limitations for the 
proposed COU. Once CDRH has determined whether or not to qualify a tool, CDRH intends to 
notify the MDDT submitter in writing of the decision.   
 
CDRH also intends to make public certain high-level information about MDDTs that are 
qualified, as described in Section V.  
 
C.  Potential Changes to Qualification Status 
 
After an MDDT is qualified, its developer may wish to modify or expand its COU in response to 
new data or changing science. Modification or incremental expansion of the qualified COU over 
time may be undertaken through the MDDT program. There may also be situations where the 
basis upon which an MDDT was qualified has changed, and CDRH may re-evaluate the 
qualification decision.   
 
D.  Regulatory Considerations and Related 
Recommendations 
 
Some MDDTs may meet the definition of a device in section 201(h) of the FD&C Act. Whether 
an MDDT is a medical device under section 201(h) of the FD&C Act will often depend on how 
12  Contains Nonbinding Recommendations 
 
 
it is intended to be used. For example, if the MDDT is only for use in device development/ 
evaluation and is not for use in diagnosing or treating patients or study subjects, it is unlikely that 
it would be a device. On the other hand, if the MDDT is intended for use in diagnosing or 
treating, or aiding in the diagnosis or treatment of subjects in a clinical study or in clinical 
settings (outside of a clinical study), it would likely be a device and would not be an MDDT. 
Some MDDTs may have both device and non-device uses.   
 
MDDT use in Clinical Studies  
Devices intended for use in clinical investigations are exempt from most requirements applicable 
to devices, including premarket clearance or approval, as long as the investigation complies with 
applicable requirements, such as those under 21 CFR Part 812, or is exempt from such 
requirements.14 As MDDTs would typically be used in the research or investigation of a medical 
device, MDDTs that are devices would typically be exempt from clearance, approval, and other 
device requirements, as long as the clinical investigation is compliant.  
 
The use of an MDDT in a medical device clinical study does not change the Investigational 
Device Exemption (IDE) requirements for a given investigation (see 21 CFR Part 812). MDDT 
qualification does not obviate the need for a device developer to meet existing regulatory 
requirements or alter the benefit-risk threshold for regulatory decision-making related to a 
medical device; rather, it can facilitate the development and regulatory evaluation of a medical 
device by providing a more efficient and predictable means for collecting the necessary 
information to make regulatory assessments.  
 
Qualification of an MDDT versus Clearance or Approval of a Medical Device 
FDA qualification of an MDDT is different from FDA clearance or approval of a medical device. 
The type of evidence needed to support MDDT qualification is not the type of evidence that is 
needed to support marketing authorization for a medical device. As described in Section IV.B, 
FDA intends to evaluate tool performance characteristics, reliability and reproducibility when 
making qualification determinations. For clearance or approval, FDA evaluates whether the 
device is substantially equivalent or has a reasonable assurance of safety and effectiveness. As a 
result, using a qualified MDDT for clinical treatment or diagnosis of a patient when it is not 
cleared or approved could cause unexpected harm to patients. 
 
Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause 
serious adverse health consequences to patients, who are not aware they are being diagnosed or 
treated based on results of tests with research or investigational products. To avoid confusing or 
misleading healthcare providers or patients, we recommend that tool developers make clear to 
users that qualification does not constitute FDA clearance or approval of the product as a 
medical device. For example, prominent statements that a tool developer makes in MDDT 
labeling and promotional materials regarding the qualification of its product by FDA as an 
 
14 If the device that is the subject of the investigation is significant risk, as defined at 21 CFR 812.3(m), the 
investigation, including use of the MDDT, is subject to all requirements in 21 CFR Part 812.  If the device that is the 
subject of the investigation is not a significant risk device, the abbreviated requirements listed under 21 CFR 
812.2(b) apply to the investigation, including the use of the MDDT.  Investigations, including the use of an MDDT, 
that meet the criteria for one of the exemptions described at 21 CFR 812.2(c), including 812.2(c)(3), are not required 
to comply with 21 CFR Part 812 with the exception of section 812.119.     
13  Contains Nonbinding Recommendations 
 
 
MDDT could be accompanied by language clarifying that the qualification of an MDDT does not 
constitute FDA clearance or approval. As another example, a tool developer could prominently 
convey that the qualified COU only applies to the use of the product in device development or 
evaluation, and that the tool has not been cleared or approved by FDA. In addition, to avoid 
labeling that is misleading, manufacturers of MDDTs that are also legally marketed medical 
devices should separate FDA-regulated labeling from materials used for the product as an 
MDDT. Tool developers may see different ways to address these labeling concerns and are 
encouraged to discuss other approaches with the FDA review team when proposing its MDDT.   
 
MDDT qualification as compared to consensus standards and device-specific FDA guidance 
The MDDT program15 is not meant to replace the consensus standard development and 
recognition processor FDAs issuance of device-specific guidance documents. FDA views the 
MDDT program as a complementary program for evaluating and recognizing tools that are 
useful for medical device evaluation and to support regulatory decision-making.   
 
Consensus standards are typically technical methods. For methods and approaches that are 
mature and that the community recognizes as a consensus standard, obtaining FDA recognition 
of the voluntary consensus standard may be a more appropriate pathway than MDDT 
qualification.   
 
V.  Communication to Public of FDA Qualification 
Decisions 
 
Once an MDDT is qualified for a specific COU, FDA intends to accept its use by any medical 
device manufacturer for that COU. The intent of the voluntary FDA MDDT program is to 
promote the development and widespread use of tools to streamline device development and 
regulatory evaluation. FDA only intends to qualify tools where high-level information about 
such tools can be made publicly available. Specifically, FDA intends to publicly disclose a 
summary of evidence and basis of qualification (SEBQ) for qualified tools. An SEBQ includes:  
 
  A brief description of the tool and the principle of operation.  
  The qualified COU (as described in Section IV).  
  A general summary of the evidence reviewed in support of tool qualification and a 
discussion of the strength of that evidence.  
  An assessment of the advantages and limitations of using the MDDT for its qualified 
COU (as described in Section IV).  
  Contact information for how a medical device manufacturer can contact the tool 
developer for access to the tool.  
 
Any MDDT submitter with questions about the content and detail FDA intends to provide in an 
SEBQ should raise those with FDA during the proposal phase. FDA will obtain written 
permission from the tool developer before publishing the SEBQ to ensure that no proprietary 
information is shared. 
 
15 MDDT Program is available at https://www.fda.gov/medical-devices/medical-device-development-tools-mddt 
14  Contains Nonbinding Recommendations 
 
 
 
Nothing about the MDDT program is intended to place limitations or requirements on MDDT 
licensing or fees, or the degree of access to intellectual property associated with an MDDT that a 
tool developer may give to a medical device manufacturer.    
 
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