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