The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) is inviting manufacturers to participate in a pilot program to assess the qualification process for tools used to develop medical devices.
The Medical Device Development Tools (MDDT) program is part of a broader effort by the agency to improve the efficiency and transparency of its review process for premarket applications. Tools include clinical outcome assessments, biomarker tests, and nonclinical assessment methods that ultimately can be used by industry in device submissions. Once a tool is qualified—determined in part by its “context of use” and purpose—device developers would be able to use it without regulators needing to reconfirm the suitability of the tool for each submission.
“MDDT tools qualified by FDA can then be relied upon by the medical device industry in support of their device submissions to the agency, potentially reducing time and other resources needed to develop new products,” according to an Aug. 15, 2014 Federal Register notice.
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