FDA BRIEF: Week of May 16, 2016

fda guidances

Surveillance.JPG

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.

READ

522

WEBPAGE


 

EHR

 

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

READ


 

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