Guidances: Blood Glucose Monitoring Systems, Software as Medical Device, Custom Device Exemptions – Drug and Device Digest

FDA BRIEF: Week of Oct 10, 2016

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SCOPE: Studies and Criteria for 510(k)s) for blood glucose monitoring systems (BGMSs)

  • Product Codes: CGA (glucose oxidase method) CFR (hexokinase method)  LFR (glucose dehydrogenase method)
  • Studies to demonstrate performance in diverse professional healthcare settings
  • Intended use patients in all professional healthcare settings, patients in specific healthcare settings (e.g., in emergency response vehicles), patients in long-term care facilities, or patients at a physician’s office
  • Account for factors such as disease state, patient condition, physiological state, medications that might affect device performance in intended use population

OVERVIEW:

  • REDUCING THE RISK OF BLOODBORNE PATHOGEN TRANSMISSION: Validated cleaning and disinfection, Robustness of cleaning
  • PERFORMANCE EVALUATION FOR PRESCRIPTION-USE: Precision, Linearity, Method Comparison/User Evaluation,  Interference Evaluation, Flex Studies, Meter Calibration and Quality Control
  • TEST STRIP LOT RELEASE CRITERIA
  • THIRD PARTY TEST STRIPS
  • SOFTWARE
  • LABELING

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glucose

SCOPE: Studies and Criteria  for 510(k)s) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users

  • Regulated under 21 CFR 862.1345, Glucose Test System, product code NBW
  • Use capillary whole blood from fingertip
  • NOT intended for use in healthcare or assisted-use settings

OVERVIEW

  • REDUCING THE RISK OF BLOODBORNE PATHOGEN TRANSMISSION: Validated cleaning and disinfection, Robustness of cleaning
  •  PERFORMANCE EVALUATION AND CRITERIA: recision, Linearity, Method Comparison/User Evaluation,  Interference Evaluation, Flex Studies, Meter Calibration and Quality Control
  • TEST STRIP LOT RELEASE CRITERIA
  • THIRD PARTY TEST STRIPS
  • SOFTWARE
  • LABELING

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SCOPE:  To establish the scientific validity, clinical performance, and analytical validity for a Software as a Medical Device (SaMD)

  • Prepared by IMDRF- voluntary group of global medical device regulators including FDA FDA’s IMDRF webpage.
  • Globally harmonized, risk-based principles of  clinical evaluation
  • Clinical evaluation is assessment and analysis of clinical data pertaining to a medical device in order to verify the safety, effectiveness and performance. Ongoing process conducted during the lifecycle of device.

OVERVIEW:

  • DEFINITIONS:: Clinical Validity,  Scientific Validity,  Clinical Performance,  Analytical Validity of a SaMD
  • GENERAL PRINCIPLES: Clinical Evaluation,
  • CLINICAL EVALUATION METHODS, EVIDENCE, APPRAISAL: Evidence Goals,  Required Level of Clinical Evaluation,  Scientific Validity Evidence,  Generating Analytical Validity Evidence,Generating Clinical Performance Evidence,  Appraisal of Clinical Evaluation Evidence
  • LEVEL OF EVIDENCE ACCORDING TO SaMD CATEGORY: Categories, Importance of Clinical Evidence and Expectations by Category, Importance of Independent Review of Evidence by Category, Pathway for Continuous Learning Leveraging Real World Clinical Evidence

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Custom Device Exceptions

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FDA guidance on CUSTOM DEVICE EXCEPTIONS, explains the new statutory provisions and defining certain terms

  • AMENDMENT to introduce new concepts and procedures

Some of the clauses  for“custom device” qualification:

  • created or modified in order to comply with order of individual physician
  • not generally available in the US
  • designed to treat a unique pathology or physiological condition that
    no other device is domestically available to treat
  • assembled from components or manufactured and finished on a case-by-
    case basis to accommodate unique needs
  • treating a “sufficiently rare condition, such that conducting clinical
    investigations on such device would be impractical;’
  • production `limited to no more than five units per year of a particular device type
  • annual report to FDA

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