New Draft Guidance for Medical Device Development Tools

sagai

Quite Involved in Discussions
Bit of surprise for day 13th of November for me, new draft guidance released for Medical Device Development Tools.

An MDDT is a scientifically validated tool ? a clinical outcome assessment (e.g. patient-reported or clinician-reported rating scales), a test used to detect or measure a biomarker (e.g. assay for a chemical analyte or medical imaging method), or non-clinical assessment method or model (e.g. in vitro, animal or computational model) - that aids device development and regulatory evaluation.
The guidance describes a process for "qualification" of an MDDT, which reflects the FDA's determination that within a specified context of use (the use parameters for which the MDDT has been validated); the results of an assessment that uses an MDDT can support device development and regulatory decision-making. Definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the required contents of a qualification submission are also included.
The guidance does not discuss the review of MDDTs submitted as part of a premarket regulatory submission for a specific medical device, nor does it address the specific evidentiary or performance expectations for the qualification of a specific MDDT.
Once an MDDT is qualified for a specific context of use, the FDA's expectation is that it could be used by any medical device developer for that context of use. The FDA will accept the MDDT for the qualified context of use without the need to reconfirm the suitability of the MDDT. However, the existence of a qualified MDDT would not require that the tool be used during the device development or regulatory evaluation process. Other scientifically valid tools or approaches may also be used. Once the guidance is final, the FDA will make MDDT qualification decisions public by posting qualified MDDTs on its website.


I found difficult to digest its content as well as to foresee the potential extents and additional cost that may arise for manufacturers.
 

sagai

Quite Involved in Discussions
I am wondering if anyone could help to identify the scope and the measures determined in this guidance though.
 

Pads38

Moderator
Thanks for that Sagai - an interesting document that may have quite an impact.

From the brief look so far it would seem that they split the 'Tools' into 3 types, with examples given:
Clinical Outcome Assessment (COA) Examples of COA include: pain scales, quality of life or health status scores, NIH Stroke Scale.
Biomarker Test (BT)Examples of BT include: an instrument or method for measuring blood pressure (e.g., sphygmomanometry); an instrument or method for measuring certain concentrations of serum proteins.
Nonclinical Assessment Model (NAM)Examples of NAM include: in vitro models to replace animal testing, the use of tissue and other material phantoms to evaluate imaging devices, electromagnetic phantoms, and validated computational models.
To pick just one example from the last group you could have a process to allow you to qualify an alternative in-vitro test to replace all (or some of) the ISO 10993 tests - potentially saving money and avoiding delay.

The draft guidance states that they are trying to encourage innovation - for once I would suggest that this might actually do just that.
 

kreid

Involved In Discussions
I see they have issued the formal version of this now (10th Aug 2017). I am very confused by the content.

I understand how the content is linked to the title Qualification of Medical Device Development Tools.

How are:
Clinical Outcome Assessment
Biomarker Test

...development tools?

What am I missing here?

Can anyone translate for me?
 
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