What is the Medical Device Development Tools (MDDT) program?
The FDA initiated the Medical Device Development Tools (MDDT) program to facilitate device development and the timely evaluation of medical devices and promote innovation. With the help of a ready-to-use list of tools, manufacturers will be able to select tools (depending on the intended use or context of use) against which they can compare the safety, effectiveness and performance of their devices and collect the scientific evidence necessary for FDA to decide on whether the device is ready to be released in to the market. Examples of these tools are bio-marker tests, clinical reported outcomes by either the clinician or patient or non-clinical assessment models (such as cellular/animal studies or computational models). FDA would evaluate these tools and related supporting evidence by assessing whether the tool can produce scientifically proven plausible measurements within the specific context.
Why is the MDDT program essential?
A medical device manufacturer needs to demonstrate the safety, effectiveness, and performance of the device before it is released into the market and approved by the FDA. The FDA’s Medical Device Development Tools (MDDT) program will be able to accelerate this process by allowing manufacturers to choose from a list of MDDT already approved by the FDA against which they can compare and assess these attributes within the same context of use. The MDDT program will ensure that the FDA comprehends how the device works, and will help inform a decision while evaluating the safety, efficacy, and performance of the device from the regulatory point of view.
What is the Purpose of the MDDT Program?
The program intends to:
- Help in the evaluation of novel technologies. This can be done by fully comprehending the scientific principle/model of the device.
- Help medical device manufacturers in the assessment of their device by comparing it with a tool enlisted in the MDDT program.
- Improve the efficiency and practicality throughout the product lifecycle especially in the area of validation.
- Encourage medical device manufacturers to collaborate with the FDA in developing the tools for the MDDT program and help in the generation of supporting evidence.
What are the MDDT Categories?
There are mainly 3 categories the FDA has stated for MDDT created according to how the FDA measures the relevant parameters:
Clinical Outcome Assessment (COA)
Reports generated by a clinician, patient, non-clinical observer or performance-based assessment. It does not merely consist of a score or outcome but also contains information of defined methods and instructions for administering the tool and a standard format for data collection. Even the methods used for scoring analysis and results for interpretation are clearly defined. The following are the 4 common types of COAs:
Patient-reported outcome (PRO) measures
This is a report from the patient directly regarding the patient’s health condition without the interference of the clinician or anyone else. PRO is unique in a way that symptoms and other unobservable concepts (such as pain intensity and quality of life) can be measured only by this method. One such example is the EXAcerbations of Chronic Pulmonary Disease Tool – Patient Reported Outcome (EXACCT-PRO).
Observer-reported outcome (ObsRO) measures:
ObsRO measures are reported by a parent, caregiver or someone who observes the patient on a day-to-day basis. This method is used in the case when the patient cannot respond by themselves (for example, an infant or cognitively impaired patients).
Clinician-reported outcome (ClinRO) measures
These measurements come from the clinician in cases where their clinical judgment and interpretation of the observable signs or other physical manifestations can help provide feedback of the patient’s health status.
Performance outcome (PerfO) measures
PerfO is dependent on the patient’s motivation and cooperation and will be administered/assessed by a health care professional. Tests such as cognitive testing, memory recall, gait speed, etc. come under this category.
Biomarker Test (BT)
Test or instrument to measure a biomarker of a particular disease to assess risk, or identify safety concerns or predict treatment outcomes in patients. BTs can be used to define inclusion or exclusion criteria in order to determine patient selection and also asses the outcome of a treatment (before and after the treatment).
Nonclinical Assessment Model (NAM)
Bench tests (in vitro) or tests which do not involve human subjects in a hospital/clinical setting (ex vivo) to measure or predict device function. It can be a computational or animal model and have the following advantages:
- Measure/predict the parameter that the device of interest claims to measure.
- Replace/reduce animal or human testing, test duration or sample size.
In the area of AI, one such NAM is the tool Certify-AI which allows developers to choose from an array of services to test algorithm performance across varying imaging devices, clinical facilities and demographic populations. The FDA recognizes Certify-AI as a means of evaluating rigorous testing and guidance on algorithm performance.
In device development, MDDT can serve specific roles such as:
- Determination of clinical endpoints (sometimes even surrogate and intermediate endpoints).
- Stratification of patient population by determining predicted risk and definition/recognition of the occurrence of an adverse event.
- Enrichment of the study population and selection of clinical study subjects.
- Development of post-market surveillance methodologies for instance, the capture of methods to capture real world outcomes.
What is the Qualification Process?
The qualification process consists of the following two phases:
1. The Proposal Phase
In this phase the performance criteria of the tool should be determined to assess the qualification of the tool in the MDDT program. Submitters should provide information of the tool particularly focusing on the data collection plan and the context of use. FDA developed a Qualification Plan Template to help submitters provide all the relevant details to get through this phase.
2. The Qualification Phase
In this phase, the submitter has to provide the FDA with the full qualification package to determine whether the tool is qualified for a specific context of use. The evidence needs to be sent only after the FDA notifies that the MDDT has been accepted into the Qualification Program. The FDA also provides a template for this phase termed, “Summary of Evidence and Basis of Qualification (SEBQ)”.
How can RookQS help?
Depending on the scope of the device a manufacturer wishes to release in to the market RookQS can assist in:
- Determining the ideal tool from the MDDT list against which the device can be compared to demonstrate the safety, effectiveness and performance of the device.
- Provide advice on the best validation tests/methods to expedite the release of the device in the market throughout the product life cycle.
In addition, RookQS can also provide expert assistance in the preparation of the documents to be submitted to the FDA in the Proposal or Qualification Phase, ensuring all the requirements are met before submission if the submitter would like to enroll the device in the MDDT program.
- U.S. Food and Drug Administration, “Medical Device Development Tools (MDDT),”
- U.S. Food and Drug Administration, “Qualification of Medical Device Development Tools,”