FDA BRIEF: Week of Oct 10, 2016

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glucose.JPG

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

READ


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

READ


INDRF.JPG

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

READ


Custom Device Exceptions

Image result for Custom devices guidance

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

READ

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