FDA BRIEF, Week of August 1, 2016

fda guidances

IRB.JPG

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 

READ


 

510k changes.JPG

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

READ


software.JPG

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

READ


 

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