News from and about the FDA.
- The FDA will host a webinar on Thursday, June 2, at 2:00 to 3:00PM to discuss how the FDA regulates diabetes devices and ongoing efforts to accelerate the availability of artificial pancreas devices. The dial in for the US is provided as: 888-603-9738; passcode: 8218260.
- The FDA has updated its CDRH Early Feasibility Study (EFS) elearning module to include a new section on the Device Evaluation Strategy. “A Device Evaluation Strategy within the Report of Prior Investigations describes and justifies the appropriate testing to support initiation of a clinical study.” This may be of interest to mHealth developers or those considering mobile medical apps.
Source: FDA Website
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