FDA Guidances and Legislation: Patient Reported Outcome in COPD, Pediatric Study Plan, MEDTECH Act – Drug and Device Digest

FDA Brief: Week of Mar 7, 2016

fda guidances


COPD guidance

  • Drug Development Tool (DDT) : Clinical Outcome Assessment (COA) for Patient-reported outcome (PRO) instrument for Chronic Obstructive Pulmonary Disease (COPD)
  • For exploratory use  to measure respiratory symptoms in patients with stable COPD
  • Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary : E-RS: COPD
  • E-RS: COPD total score qualified for exploratory use as a PRO instrument to measure respiratory symptoms of stable COPD in clinical studies
  • Additional development work needed to further assess measurement properties, including ability to detect clinically meaningful change, treatment effect on reducing respiratory symptoms from baseline levels



PSP guidance

  • Provide information on submission of initial pediatric study plan (iPSP) and amendments
  • Addresses:
    • Who must submit
    • When it must be submitted
    • What should be included
    • What should be included in amendment
    • Use of template




  • Senate panel approved  legislation on clinical decision support (CDS) software
  • CDS represents a wide range of technologies, from common automated alerts and reminders to software that relays data to and from implanted devices
  • Commonly used CDS tools help providers with drug-prescribing decisions
  • MEDTECH Act Legislation bans FDA  from regulating certain categories of software, including CDS software and electronic health records
  • However, bill only exempts CDS if the software is designed to enable doctors to double-check the tool’s recommendation.
  • Thus, majority of the software affected by the MEDTECH legislation is very low risk





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