FDA BRIEF, Week of August 1, 2016
Prepared by : Office for Human Research Protections (OHRP) and FDA
For: IRBs and institutions responsible for review and oversight of human subject research
Required Written procedures:
- Conducting initial and continuing review of research
- Reporting findings and actions to investigator/institution
- Determining which projects require review more often than annually
- Determining which projects need verification from sources other than investigator
- Ensuring prompt reporting to the IRB of proposed changes in a research activity
- Ensuring prompt reporting to the IRB, OHRP, FDA of any unanticipated risks, noncompliance, suspension or termination of IRB approval
IRB Written Procedures Checklist
Clarify: When a medical device change would trigger submission a new premarket notification – 510(k)
Guiding Principles:
- Modifications significantly affect safety or effectiveness
- “Could significantly affect” evaluation and the role of testing
- Unintended consequences of changes
- Use of risk management
- Evaluating simultaneous changes
- Appropriate comparative device and cumulative effect of changes
- Documentation requirement
- Submissions for modified devices
- Substantial equivalence determinations
Considerations for:
- Labeling changes
- Technology, Engineering, Performance changes, Materials Changes for In Vitro Diagnostic Devices
- Risk Assessments of Modified Devices
Flowcharts provided
WEBINAR on Aug 25th
Clarify: When a software (including firmware) change to a 510(k)-cleared device may require new 510(k)
Software modifications:
- Adaptive – modification of software to keep it usable in a changed or changing 197 environment
- Corrective – reactive modification of software to address discovered faults
- Perfective – modification of software to improve performance or maintainability.
Guiding Principles:
- Modifications significantly affect safety or effectiveness
- “Could significantly affect” evaluation and the role of testing
- Unintended consequences of changes
- Use of risk management
- Evaluating simultaneous changes
- Appropriate comparative device and cumulative effect of changes
- Documentation requirement
- Submissions for modified devices
- Substantial equivalence determinations
Considerations:
- Solely to strengthen cybersecurity
- Solely to return system into specification of the most recently cleared device
- Introduce a new cause or modify an existing cause of a hazardous situation
- Introduce a new hazardous situation or modify an existing hazardous situation
- Create or necessitate a new risk control measure or modification of existing measure
- Significantly affect clinical functionality or performance specifications associated with intended use
Common Software Change Types: Infrastructure, Architecture, Algorithm, Core algorithm, Clarification of Requirements – No change to Functionality, “Cosmetic Changes – No change to Functionality, “Reengineering” and “refactoring”
Flowcharts and Examples provided
WEBINAR on Aug 25th