FDA BRIEF: Week of June 6, 2016
Globalization and FDA’s New Partnerships to Ensure Product Safety
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.
- 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)
- 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
OBJECTIVE: Provide harmonized principles of genomic sampling and management of genomic data in clinical studies
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
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