The Food and Drug Administration (FDA) on Wednesday concluded a guidance which was initially drafted in 2013, to formalize a program that qualifies medical device development tools (MDDT) for use in device improvement and assessment programs.
The MDDT program is an approach for the FDA to qualify tools to develop and evaluate medical devices used by medical device sponsors. Qualification, here, implies that the FDA has assessed the tool and agrees, with accessible supporting evidence, that MDDT creates scientifically-plausible measurements, and also works in accordance to the predetermined context of use. When an MDDT is submitted in line with the new FDA guidance, and gets qualified for a definite framework of use, it allows its use by any device sponsor for that context of utilization. For example, Vextec’s virtual life management certification was one of the first to be accepted into the MDDTs program.
Categorization of the MDDT Program
The FDA guidance has defined three categories for the MDDT program – clinical outcome assessment, biomarker test and nonclinical assessment model. To participate voluntarily in the MDDT program, there are no fees in relation with submitting a tool for qualification. Any medical device manufacturer, tool developer or organization can submit a proposal for their tool at the website.
The finalized guidance further confers regulatory concerns, such as situations in which an MDDT is in line with the definition of a device, using MDDTs in clinical trials and several phases of the voluntary qualification process. The voluntary qualification process comprises of the following phases:
- Proposal phase
- Incubator phase (optional)
- Pre-Qualification phase (optional)
- Qualification phase
MDDTs to Go Public Soon
Further, the FDA considers MDDT description, the context of use, public health impact, the strength of evidence, and the assessment of advantages & disadvantages while determining whether to qualify a proposed MDDT. The FDA won’t put constraints or prerequisites on MDDT licensing or fees, or limit the level of access to intellectual property related with an MDDT that a tool developer may provide to a device sponsor. The FDA will list MDDTs in public as soon as they are qualified, with a summary of evidence and basis of qualification for the tool.
Before participating in the program, the tool submitter can consult with the FDA, within the proposal phase, the level of data they consider proper for public revelation. The FDA just expects to qualify tools, where the data is contained in the summary of evaluation, and where basis for qualification can be made public. The US FDA will also host an event to explain this finalized guidance more on 24 August.