FDA BRIEF: Week of August 7, 2017
Software Precertification Pilot program
Part of Digital Health Innovation Acton Plan, conforming to software
provisions of the 21st Century Cures legislation
- Voluntary program for medical device software manufacturers
- Need to demonstrate Culture of Quality and Organizational Excellence (CQOE)
Pre-Cert status allows
- Ability to get software to market faster
- Iterate based on real world experience
- Have regulatory predictability
FDA Goals
- Modern and efficient regulatory framework
- Easy to obtain and maintain FDA Pre-Cert
- High quality, safe and effective software throughout product life
- Enable companies to demonstrate CQOE and measure Key Performance Indicators
- Enable scalability, variation and evolution of software development
- Learn and adapt based on program effectiveness
Medical Device Tool Development (MDDT)
MDDT program for qualification of tools for medical device sponsors in the development and evaluation of medical devices
- Promotes innovation in medical device development
- Bridge gap between research of devices and the delivery of devices to patients
‘Qualification’ based on FDA evaluation of evidence that
- tool produces scientifically-plausible measurements
- works as intended within the specified context of use
Context of Use
- tool or product area
- specific output or measure
- role in device development
- applicable phases of device development
Categories
- Clinical outcome assessment
- Biomarker test
- Nonclinical assessment model
Optimizing GUDID Data Quality
The Global Unique Device Identification Database (GUDID)
- FDA database to serve as a reference device catalog device with an identifier
- Labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID
- UDI integration from manufacturing through supply chain to patients,electronic health records (EHRs) and registries
FDA’s Focus on GUDID Data
- Acceptable quality to realize public health benefits
- Accuracy and completeness of data
- Engage with stakeholders to optimize data quality and utility
China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards
By: Theresa M. Mullin, Ph.D., Director of FDA’s Office of Strategic Programs, CDER
Drug development is a global endeavor
- Requires consistent standards adopted and adhered to global drug makers and regulatory authorities
FDA meeting with China Food and Drug Administration (CFDA)
- CFDA joins the existing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Currently includes eight regulatory authorities and six industry associations from across the globe
Steps taken by CFDA
- Implemented reforms to align China’s regulations with global standards
- Reformed drug review system, dedicated additional resources, implemented ICH Guidelines
- Will visit FDA to continue conversation on regulatory modernization
Image credit: FDA