FDA ’s Still Fledgling MDDT Program

FDA released its final guidance on Medical Device Development Tools (MDDT) in August 2017, following the draft of November 2013. MDDT’s are pre-qualified methods, materials, or measurements that can be used to assess, at least in part, the effectiveness, safety, or performance of a medical device for regulatory submission purposes. The idea behind MDDTs is that the evaluation of a device for market entry (i.e., 510(k) or PMA) would be streamlined if the things that were necessary to perform the evaluation were known in advance to have been proven appropriate. Once a tool was qualified by FDA, it would be accepted without further proof that it was appropriate, thereby reducing the regulatory burden. The burden reduction would be especially true if a tool was going to be used multiple times. As noted in an FDA webinar, CDRH reviewers should accept a qualified MDDT for the already identified context of use without the need to reconfirm the appropriateness of the tool. As shown on the MDDT web page, two MDDTs have been qualified to date, both of which are patient questionnaires in the cardiovascular arena. FDA identified three types of MDDTs that could be qualified: Clinical Outcome Assessments. Survey instruments that measure how a patient feels or functions (e.g., the questionnaires noted above). Biomarker Tests. Tests or instruments used to detect or measure a biomarker. Non-Clinical Assessment Models. An in vitro, ex vivo, or in vivo (animal) model or method that measure...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news