FDA Guidances: UDI Enforcement, Patient-Specific Information Dissemination – Drug and Device Digest

FDA BRIEF: Week of August 29, 2016

fda guidances


UNIQUE DEVICE IDENTIFICATION (UDI) rule, published 9/2013, for medical devices

  • Standardized identification system to rapidly and definitively identify device and key attributes
  • Phased enforcement over 7 years based primarily on device classification

RESCINDS legacy identifiers

  • NHRIC or NDC numbers on  labels and packages
  • 11-digit reimbursement number, typically using an NHRIC or NDC number


  • Pharmacies and payers rely on NHRIC and NDC numbers for reimbursement
  • Removal could cause disruption to existing reimbursement, supply chain, and procurement processes

REVISED FDA Enforcement Policy

  • Provide additional time to remove dependence on NHRIC/NDC
  • Labeler may continue use of previously assigned FDA labeler code under a system for the issuance of UDIs – for use in reimbursement numbers
  • New UDI implementation compliance dates
  • UDI Webpage Webpage.JPG




APPROPRIATE & RESPONSIBLE dissemination of patient-specific information

  • Recorded, stored, processed, retrieved, and/or derived from medical devices
  • From manufacturers to patients
  • To empower patients to be more engaged with their healthcare providers in making sound medical decisions


  • Any information unique to an individual patient or unique to patient’s treatment or diagnosis
  • May include recorded patient data, device usage/output statistics, healthcare provider inputs, alarms, records of device malfunctions/failures
  • Does not include data interpretations


  1.  Data from healthcare provider to record status and ongoing treatment of patient
  2. Information stored by device to record usage, alarms, or outputs


  • No additional premarket review if consistent with cleared label
  • Does not impact HIPAA Privacy Rule
  • Content:
    • Interpretable and useful to patient
    • Prevent confusing or unclear information that could be misinterpreted
    • Consider  intended audience characteristics that may affect interpretability
    • May provide supplementary information to aid patient understanding
  • Context:
    • Include relevant context to avoid misinterpretation, incorrect conclusions
    • Information on contact for follow-up information – healthcare provider at a minimum.


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