FDA BRIEF: Week of June 6, 2016

Voice

Globalization and FDA’s New Partnerships to Ensure Product Safety

Howard Sklamberg

by: Howard Sklamberg,  Deputy Commissioner for Global Regulatory Operations and Policy

CHALLENGE: Ever-increasing volume and complexity of FDA-regulated products coming to US with has ramifications for our nation’s public health.

  • 34 million shipments
  • 130,000 importers
  • 300,000 foreign manufacturers

SOLUTION: Risk-based approach to oversight by partnering with foreign regulators in verifying safety standards

 

  • Medical Device Single Audit Program : International approach to auditing and monitoring of DEVICE manufacture and quality management systems. Australia, Brazil, Canada, Japan, and the U. S. in pilot
  • Mutual Recognition Agreements:  Recognize each other’s drug Good Manufacturing Practice (GMP) inspections for DRUG manufacturing US and EU

NEXT: Continued careful reliance on trusted foreign partners and minimization of public health risks globally.

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fda guidances

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SCOPE:

  • Appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices
  • From manufacturers to patients

CATEGORIES OF PATIENT-SPECIFIC INFORMATION:

  • Data a healthcare provider inputs to record  status and ongoing treatment
  • Information stored by device to record usage, alarms, or outputs (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a pacemaker)

DISSEMINATION POLICY:

  • Content:  Paitent specific, interpretable, comprehensive and contemporary. Provide supplementary instructions, materials or references to aid patient understanding – may extend to labeling
  • Context: Include relevant context to avoid misinterpretation; advise patients to contact healthcare providers to discuss

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E18

OBJECTIVE: Provide harmonized principles of genomic sampling  and management of genomic data in clinical studies

SCOPE:

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FR.JPG

triggerfish.JPG

REQUEST:

April 28, 2014:Sensimed AG requested classification of the SENSIMED Triggerfish® device under section 513(f)(2) of the FD&C Act. Recommended class II

FDA REVIEW:

March 4, 2016: FDA reviewed and believes special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.Issued  order classifying into class II; codified .21 CFR 886.1925.

GENERIC NAME: Diurnal pattern recorder system

Nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.

IDENTIFIED RISKS & MITIGATIONS:

  • Ocular Adverse Events (eg Hyperemia, Punctate keratitis, Dry eye, Foreign body sensation, Itching, burning, Swelling of eyelids, Pick eye, Excessive watering): Clinical testing, Biocompatibility, Labeling
  • Infection : Sterilization, Labeling
  • Adverse Tissue Reaction: Biocompatibility, Labeling
  • Software Malfunction: Software Verification & Validation, Hazard Analysis
  • Hardware Malfunction: Nonclinical Testing
  • User Error: Clinical Testing
  • Electromagnetic Interference with Other Devices: Electromagnetic Compatibility & Interference Testing, Labeling
  • Electrical Malfunction: Electrical Safety Testing, Labeling
  • Incorrect Graphical Representation of Variation due to measurement noise: Labeling

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