Presentations from #FDAPreCert 30JAN2018 workshop are up. @CMMI_Institute presentation starts on p. 29. https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM597304.pdf Contact @2HarborsConsult about #MDDAP if interested in pilot program providing regulatory benefits now @KimKaplan_US @bltfitz @MDIConline
FDA Commissioner Scott Gottlieb (@SGottliebFDA) wants to create a Center of Excellence on Digital Health “to establish the regulatory paradigm, build new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. To modernize and expand its existing capabilities to ensure the cybersecurity of medical devices, the FDA would enhance its ability to coordinate device-specific responses to cybersecurity vulnerabilities and incidents. The FDA also would implement […]
Interested in the Medical Device Discovery Appraisal Program (#mddap) and how it uses @CMMI_Institute framework to help medical device companies and get regulatory modifications from the @FDAcdrhIndustry? Attend the next CfQ webinar Feb 27: http://mdic.org/mdicx/ In 2017, CDRH launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (http://mdic.org/cfq/enroll/). CDRH expects the pilot to continue through 2018 and MDIC […]
Just over an hour long, Dan Matlis sat down with the Program Manager for the Case for Quality, Cisco Vicenty to discuss the goals and state of the program. https://www.youtube.com/watch?v=Z4BLB3yZuGw. Cisco discusses the objectives of the CfQ, what FDA have been learning from the program and the CMMI Medical Device Discovery Appraisal Program (MDDAP).
“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/
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 can be adapted for the medical device industry was selected for this CfQ Pilot Program. The CMMI system is a […]
The FDA’s commissioner Scott Gottlieb made several large announcements this week that reflect a continued drive to reduce regulatory burden to industry to foster an environment for innovation and allowing greater speed to market for regulated products. Earlier in the week the Agency announced its intentions to publish a guidance to “modernize” the 510(k) process: “FDA intends to publish a draft guidance, again in early 2018, setting forth factors that the agency may consider when assessing […]
Presentations from the latest CfQ forum are up on the MDIC site (https://lnkd.in/e3hvHsb). We strongly recommend reviewing Rob Becker’s presentation regarding his medical device organization’s experience going through a CMMI appraisal, what he found valuable and what were challenges: https://lnkd.in/ga4SHm7
Curious as to where FDA inspections have been the last 10 years? Checkout the inspections database: https://www.fda.gov/ICECI/Inspections/ucm222557.htm
Two Harbors Consulting has been working closely with partners in industry, the Medical Device Innovation Consortium, the Food & Drug Agency, and the CMMI Institute to further the Case for Quality program leveraging the CMMI Maturity Model as a framework to assess and drive quality improvements in medical device firms. As background, please review FDA Director of CDRH, Dr. Jeff Shuren describes the Case for Quality here. The CMMI Institute has provided a comprehensive FAQ […]
