miércoles, 9 de agosto de 2017

CDRH Industry: FDA Issues Final Guidance on Qualification of Medical Device Development Tools

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Today, the Food and Drug Administration (FDA) released the final guidance, Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff.  This guidance formalizes the Medical Device Development Tools (MDDT) program, which the FDA launched as a pilot in 2013.
An MDDT is a scientifically validated tool – a clinical outcome assessment (for example, patient-reported or clinician-reported rating scales), a test used to detect or measure a biomarker (for example, assay for a chemical analyte or medical imaging method), or a non-clinical assessment method or model (e.g. in vitro, animal or computational model) - that aids device development and regulatory evaluation. The MDDT program is a voluntary process intended to reduce regulatory burden for tool developers and FDA reviewers through the qualification of tools that can aid in the development and evaluation of medical devices.
The final guidance clarifies the qualification process for an MDDT, which reflects the FDA’s determination that the results of an assessment using an MDDT can support device development and regulatory decision-making within a specified context of use (the use parameters for which the MDDT has been validated). FDA qualification of an MDDT is different from FDA clearance or approval of a medical device. The type of evidence needed to support MDDT qualification is not the type of evidence that is needed to support marketing authorization for a medical device.
The FDA will publicly list MDDTs once they are qualified, along with a summary of evidence and basis of qualification for the tool. This information will include a brief description of the tool, the qualified context of use, a general summary of evidence to support qualification, a brief assessment of the advantages and disadvantages, and information on how to contact the tool developer about accessing the tool. Before publicly disclosing any of a tool developer’s proprietary information, the FDA will obtain written permission from the tool developer.  
On Thursday, August 24, 2017, from 1:00 PM - 2:30 PM, the FDA will host a webinar “CDRH Final Guidance: Qualification of Medical Device Development Tools” for tool developers and participants interested in learning more about the program. More information about the webinar is available at http://www.fda.gov/cdrhwebinar.
More information about the MDDT program is available on the FDA’s Medical Device Development Tools webpage.
Center for Devices and Radiological Health
Food & Drug Administration

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