March 14, 2019

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements. Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...

Mar

FDA qualifies software module biomarker test

March 14, 2019Brian PateNews

Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...

Mar

FDA Medical Device Development Tool (MDDT) Qualification

March 14, 2019Brian PateNews

Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices. The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...

FDA Exempts Flow Cytometry from 510(k) requirements

FDA qualifies software module biomarker test

FDA Medical Device Development Tool (MDDT) Qualification

SoftwareCPR Training Courses

Corporate Office

Day

FDA Exempts Flow Cytometry from 510(k) requirements

FDA qualifies software module biomarker test

FDA Medical Device Development Tool (MDDT) Qualification

SoftwareCPR Training Courses

Corporate Office