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In December the FDA issued two rules that will affect the classification and reclassification of medical devices. The first rule, which will become final on 18MAR2019, the agency is amending 21 CFR Part 860 to establish new processes for PMA applications for...

In December, the FDA issued their first report on the impact of changes to the regulation of non-device software functions under the 21st Century Cures Act. These changes removed certain software functions from the definition of a medical device in the amended...

Guidance on When and What to File for Holders of PMAs/HDEs/IDEsCDRH and CBER have issued a new guidance clarifying the definitions of changes to a manufacturing site for medical devices and giving clearer instructions on what type of supplement to file for each type...

In early December the FDA published their Framework for Real World Evidence (RWE) Program. The intent of the program is to allow the agency to work with sponsors to evaluate the use of RWE to support approval of new indications or satisfy post-approval study...

I have many interesting topics and ideas to share with you in 2019, including new ways to look at device approvals, some new reading lists, and posts on topics as varied as data integrity, clinical trials design, and medical software apps. Have a wonderful new...

In a recent issue of SBIA Chronicles, the agency is encouraging sponsors to request type C meetings early in the development process when they plan to use novel surrogate endpoints (SE) as primary measures of efficacy in trials for a new drug. These SE are biomarkers...

– For New Medical DevicesPatients whose insurance policies don’t cover innovative new treatments are often excluded from treatments that could be beneficial because they can’t afford them. The FDA is working on approaches to minimize the delay between approval and...