Industry comments positively on the Digital Health Precertification Program

“When it comes to digital health, the FDA has leapfrogged industry” and  “Industry adherence to slow-moving, old-school regulations and guidance documents has had terrible unintended consequences that have been detrimental to public health.” Wow.  Incredible read written by one of the participants in the Digital Health Precert program: https://tidepool.org/fda-precert-site-visit-recap/  Advertisements

FDA announces “Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program”

FDA has announced “Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program” at https://www.federalregister.gov/documents/2017/12/28/2017-28044/fostering-medical-innovation-case-for-quality-voluntary-medical-device-manufacturing-and-product – contact us at Two Harbors for details. “Through collaboration with the Medical Device Innovation Consortium (MDIC) over the last 2 years, a maturity model and appraisal system (i.e., Capability Maturity Model Integration (CMMI) system) that … More FDA announces “Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program”