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

FDA BRIEF: Week of August 29, 2016

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

CONCERN

• 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 

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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

DEFINITION

• 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

CATEGORIES

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

DISSEMINATION POLICY

• 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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