FDA News and Views: Software PreCert Pilot, Medical Device Tool Development, GUDID Data Quality, China joins ICH – Drug and Device Digest

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


Collage; 1st picture is cross section of a human head; 2nd is a body with skeleton showing; 3rd is hand holding a blood pressure meterMedical 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


  • Clinical outcome assessment
  • Biomarker test
  • Nonclinical assessment model


Final Guidance

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


Group photo from trip to China


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


Scroll to Top