In line with the aim of accelerating medical device development, the FDA has issued its as-yet latest guideline, entitled “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (called just the “Draft Guidance”) on November 13, 2013.
This guideline is a voluntary process for the qualification of Medical Device Development Tools (MDDT) used in device development and evaluation programs in the Center for Devices and Radiological Health (CDRH). The aim of this qualification process is to foster “the development and timely evaluation of innovative medical devices”. The FDA seeks to do this by putting in place a relatively more competent and predictable way of garnering the necessary information needed to make regulatory assessments.
The Draft Guidance applies to therapeutic and diagnostic devices. It is specifically aimed at biomarker tools, which are considered critical to some personalized medicine diagnostics.
Applications and uses
The Draft Guidance lists the parameters that the CDRH looks for among qualified Biomarker Tests (BT’s) that it considers as being worthy of relying upon for device-related regulatory decision-making for the designated use. To quote some examples, these guidelines may be used to select patients for a device clinical trial. They could also serve as instructions to monitor treatment response. They could also relate to prediction or identification of safety problems related to treatment with a medical device. Or, they could be used to identify patients who are or are not candidates for certain forms of tests or therapies.
The FDA says it has four clear cut goals in setting out these guidelines:
o To enable quicker and more efficient development of devices
o To promote the development of new MDDT’s
o To help optimize the developments in the field of regulatory science into new MDDTs
o To engender faster and more effective communication to stakeholders the MDDT’s that are appropriate for use in development programs.