Recent MTI articles regarding MDDAP

Below are two links to two articles regarding the Medical Device Discovery Appraisal Program (MDDAP) from the on-line publication, MedTech Insight.   These articles are part of a series that MTI has been doing on the program.  These articles specifically get into appraiser qualifications and their insights on this program and the possibility of FDA staff … More Recent MTI articles regarding MDDAP

FDA proposes a Center of Excellence for Digital Health

From https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm  “This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. Our Digital Health Innovation Action Plan demonstrates our commitment to spurring digital health innovation and safety. With the creation of a … More FDA proposes a Center of Excellence for Digital Health

Third in series MDICx webinar and Greenlight Guru series regarding the Case For Quality.

Last week was a third MDICx webinar regarding the MDDA program.  In addition to Kim Kaplan from the CMMI Institute and Cisco Vicenty from FDA CDRH providing updates regarding the program, Kathy Bardwell from Steris and Stephanie Fossat-Dominguez from Celonova presented on their experiences in the program.  You can rewatch the webinar here:  https://www.youtube.com/watch?v=wvwC97SGH-M Additionally, … More Third in series MDICx webinar and Greenlight Guru series regarding the Case For Quality.