Document Center has many customers in the Medical Device field, and many of those have devices under development. Recently, companies have been turning to MDDT’s (Medical Device Development Tools) during the process of FDA regulatory review. However, this has been happening on a case-by-case basis. So those of you in this situation will be pleased to know that there’s a new draft document that offers a plan for a validation of such tools. It’s titled “Medical Device Development Tools – Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff.” You can get a copy from Document Center now.
The proposed validation process would cover 3 distinct types of tools, based on how the tool measures the relevant parameters –
- COA (Clinical outcome assessments): tools that measure clinical parameters by a subjective metric
- BT (Biomarker tests): tools that measure clinical parameters using physical measurement or chemical analysis (an objective approach)
- NAM (Nonclinical assessment models): tools that measure nonclinical parameters
These tools will also be categorized by the context of use. This is the way the MDDT is to be used and why. An accepted tool would need to be validated for one or more of the following uses:
- Aid in diagnosis – either to define adverse events or as a reference to assist in the diagnosis process
- Patient selection – not only to select patients, but to sort them by the predicted risk
- Clinical endpoints – for either the intermediate endpoint or surrogate endpoints, that is points in the process that show improvements in symptoms or in patient functions that should lead to the desired effect
- Non-clinical device assessment – bench or animal studies that reduce the test duration or sample size, or other approaches like in vitro or in silico studies to reduce the use of animals for testing.
The FDA goes on to describe a plan for accepting and qualifying these types of tools for future use. This would mean that if a particular tool has been qualified for a specific usage, that tool would no longer need to be reviewed for each application. Net result? A reduction in the time and cost to the FDA (and to device developers) for the acceptance of devices.
This document is a draft, circulated for 90 days for public comment. Should this material impact your business, you should get a copy right away and review the contents carefully. At the minimum, you’ll be better prepared for possible changes in the regulatory review process that it represents. At the best, you may find sections where you can offer improvements or other comments of importance.
Medical device manufacturers use Document Center to monitor and deliver documents like this. Why? Because we are perhaps the only standards dealer that monitors regulatory material like this. And because we can provide superior support services to support the compliance documentation needs of organizations like yours. Use our web store, www.document-center.com, to order the publications you need. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have any number of services that can improve the way you do business. Make us your Standards Experts!
