FDA Issues Final Guidance on Medical Device Development Tools
September 5, 2017
On August 10, 2017, the U.S. Food and Drug Administration (FDA) issued its final guidance on the Medical Device Development Tools (MDDT) program. Per the final guidance, an MDDT is “a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device. An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making.” The program is voluntary and can be developed by any interested party.

3 Defined Categories of MDDTs:

  1. Clinical outcome assessment (COA) — measures a patient experience or function. A COA could include patient-reported, observer-reported, or clinician-reported rating scales or performance outcome measures, such as measures of gait speed or memory recall. These tools may be subjective parameters.
  2. Biomarker test (BT) — defined as a lab test or instrument used to measure a biologic processes or response to a treatment such as hormone levels. A BT may include tests used in diagnosis (including imaging and assays), patient selection, clinical study endpoints, or to predict or identify outcomes. These tools are generally objective measures.
  3. Nonclinical assessment model (NAM) — a nonclinical test method or computational model that measures or predicts device function or in vivo device performance. Examples include models that help reduce or replace animal testing. These may include assessments such as computational fatigue simulations or wear simulation protocols.

Qualification of an MDDT includes consideration of the specific “context of use” (COU). Context of use defines the boundaries of evidence and justification that supports the use of the MDDT. 

The COU Should Include 4 Key Components:

  • Device or product area being qualified (e.g., total hip implant)
  • Specific output/measure from the MDDT
  • Role in regulatory evaluation (e.g., performance data for 510k) 
  • Stage of development supported (e.g., design verification).

Qualification means that the MDDT is qualified for the specific context of use and can be relied on by industry for device evaluation and to support regulatory decision making by the Center for Devices and Radiological Health (CDRH). There is no need to reconfirm suitability after qualification assuming the context is appropriate.

CDRH Qualification Process

  • Proposal phase: determines suitability of MDDT for qualification through the program.Incubator phase (optional): enables CDRH to work with submitters to foster development of tools with potential for high impact to public health.
  • Prequalification phase (optional): includes feedback from CDRH on MDDT evidence generation.
  • Qualification phase: includes determination of qualification based on specific context of use.

In qualifying an MDDT, the FDA considers the description, context of use, public health impact, strength of evidence, and the advantages and disadvantages of the MDDT (within context of use). The FDA intends to make public information on qualified tools, context of use, summary of evidence, and the justification for the decision.

MDDT Benefits

An important intent of this voluntary, no-fee program is to accelerate effective, innovative medical devices getting to patients who would benefit from them. Currently many innovative, novel technologies lack standardized bench tests and study trial designs. Manufactures find themselves “reinventing the wheel” and having to demonstrate test validity multiple times between each submission. Having access to validated standards and qualification tools facilitates agreement on device design development, verification, and validation. Additionally, relying on a qualified MDDT means there is no need to reconfirm or requalify the test suitability.

Benefits for the device industry are clear, and include more predictable product evaluation and reduced regulatory risk as well as the likelihood of less costly preclinical and clinical studies. For patients, MDDTs translate into more rapid access to innovative medical devices.

How Exponent Can Help

Exponent’s scientists and engineers have extensive expertise across many medical device specialties and product sectors. Our staff applies scientific engineering protocols to characterize and evaluate the performance of biomaterials, biologic tissues, and medical devices throughout the development process.

Our well-equipped laboratories and computational modeling capabilities enable our team to assist clients in the development of an MMDT for their innovative product or in the utilization of established MDDTs as part of the product development design process.