FDA BRIEF: Week of May 16, 2016
STATUTORY CRITERIA
- Food and Drug Modernization Act (FDAMA), 1997, amended section 522 of Safe Medical Devices Act for postmarket surveillance for a class II or class III device:
- failure would cause serious adverse health consequence
- have significant use in pediatric populations
- implanted in the human body for more than one year
- intended to be life-sustaining/supporting
IMPLEMENTATION
- Surveillance Plans: Agreement by FDA an Manufacturer
- Surveillance Reports: Interim/Final Format and Content, possible FDA actions
- Postmarket Surveillance Status Determination
- Failure to Comply with Postmarket Surveillance Requirements
- Public Disclosure of Postmarket Surveillance Plan Information and Reports.
ELECTRONIC HEALTH RECORD IN FDA-REGULATED CLINICAL INVESTIGATIONS
- Assist sponsors, clinical investigators, CROs, IRBs
- For clinical investigations of drugs, biologics, devices, combination products
RECOMMENDATIONS
- Whether and how to use
- Interoperability with supporting electronic systems
- Data quality and the integrity
- Inspection, recordkeeping, record retention requirements
BEST PRACTICES
- ONC-Certified Health Information Technology
- Data Modifications
- Audit Trails
- Informed Consent
- Privacy and Security of Data