Capture.JPGFDA’s Patient Affairs Staff (PAS)-  FDA Puts Patients First

PAS works with patients, caregivers, and advocates in 2019
  • Understanding patient experience and incorporating patient feedback into FDA’s work

PAS launched several initiatives to support and connect with patients


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The Least Burdensome Provisions: Concept and Principles

Final guidance on use of least burdensome approach to medical device regulation
  • Support timely patient access to high quality, safe and effective medical devices
  • Remove or reduce unnecessary burdens throughout total product lifecycle
  • Maintaining statutory requirements for clearance and approval
  • Principles are based on sound science, intent of the law, use of alternative approaches, efficient use of resources to effectively address regulatory issues

Guiding principles

  • FDA to request minimum information necessary to adequately address regulatory question or issue at hand
  • Industry should submit material, including premarket submissions, that are least burdensome for FDA to review
  • FDA to use most efficient means to resolve regulatory questions and issues
  • Right information provided at right time (e.g., just-in-time data collection) to address right questions
  • Regulatory approaches designed to fit technology, taking into account unique innovation cycles, evidence generation needs, timely patient access
  • FDA to leverage outside US data to the extent appropriate and feasible

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Improving security of Drug Supply Chain through innovations that improve tracking and tracing of medicines

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Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements

Intent to exempt certain unclassified medical devices from premarket notification requirements

  • Devices are sufficiently well understood
  • Do not require premarket notification (510(k)) to assure their safety and effectiveness.

Device categories

  • Ear, Nose, and Throat
  • Gastroenterology-Urology
  • General and Plastic Surgical
  • Neurological
  • Obstetrical and Gynecological Devices
  • Physical Medicine Devices

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Image credit: FDA


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