Guidances: OTC Hearing Aids, Emerging Device Signals, Electronic Informed Consent, Biomarker Qualification – Drug and Device Digest

FDA BRIEF: Week of Dec 5 and Dec 12, 2016


Immediately in Effect Guidance Document:  Flexible and adaptive regulatory approach to the oversight of hearing aids to increase availability and accessibility


  • Class I air-conduction hearing aids – 21 CFR 874.3300(b)(1)
  • Class II wireless air-conduction hearing aids- 21 CFR 874.3305


  • No enforcement of medical evaluation and recordkeeping requirements prior to the dispensing
  • Required to provide User Instructional Brochure containing specific labeling requirements prior to sale



Emerging signal:

  • New information about a marketed medical device
  • New causal association , New aspect of known association
  • Information can impact patient management decisions, benefit-risk profile


  • Signal and Signal Management
  • Considerations for FDA Public Notification
  • Content of Public Notification and Follow-up/Closure



Use of electronic systems and processes to obtain informed consent (eIC)

  • Ensure protection of rights, safety, and welfare of human subjects
  • Facilitate comprehension of information presented
  • Ensure appropriate documentation of consent
  • Ensure the quality and integrity of eIC data

Instituting eIC

  • Information presentation
  • How/Where
  • Answering questions from subjects
  • Steps to facilitate understanding
  • Electronic signatures
  • Identity verification
  • Pediatric subjects
  • Information access
  • Steps for privacy, security, confidentiality
  • HIPAA authorization
  •  IRB communications
  • Archival & FDA inspection



Aim: Create alignment among scientific stakeholders including FDA, NIH, industry, academia, patient groups and the non‐profit sector regarding a proposed framework for levels of evidence required to qualify biomarkers


  • Biomarker Categories & Milestones
  • Proposed Framework :  Assumptions, Components, Context of Use (COU)
  • Evidentiary Criteria (EC) Framework: COU, Benefits/Risks, EC data
  •  Evidentiary Criteria Level Assessment Map
  • Clinical Safety Module: Need Statement, COU, Benefit/Risk, Evidence Map , EC level assessment, References and related publications


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