fda guidances


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Procedures for Meetings of the Medical Devices Advisory Committee

Background and Scope:

  • Provide information on  processes for Medical Devices Advisory
    Committee meetings
  • Excludes Medical Devices Dispute Resolution Panel (DRP)
  • Does not apply to Device Good Manufacturing Practice Advisory Committee,
    National Mammography Quality Assurance Advisory Committee, Technical
    Electronic Product Radiation Safety Standards Committee

Overview:

  • Panel Meeting Topics
    • Advice on a Premarket Submission
    • Regulatory Issues: Classification/Reclassification, General Issues
  • Panel Expertise
    • Two or more voting members with relevant clinical expertise
    • One voting member knowledgeable about device technology
  • Preparation for Panel Meetings:
    • Premarket Submission Meetings, Briefing Material Contents, CDRH-Applicant Interactions, Regulatory Issues Meetings
  • Conduct of Panel Meetings
    • Medical Device Industry Presentations
    • CDRH Presentation
    • Open Public Hearing
    • Panel Deliberations and CDRH Questions
    • Panel Voting
  • Post Meeting Activities
  • Teleconference Panel Meetings

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FY 2017 Medical Device User Fee Small Business Qualification and Certification

Background and Scope:

  • Business qualified and certified as a “small business” is eligible for a substantial reduction in most of these user fees
  • Process to request qualification and certification as a small business – US and Foreign

Overview:

  • Eligibility
  • U.S. Businesses
  • Foreign Businesses
  • National Taxing Authority

Small Business Fees:

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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Background and Scope:

  • Real-World Data (RWD): Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources
  • Real-World Evidence (RWE): Clinical evidence regarding the usage, and potential
    benefits or risks, of a medical product derived from analysis of RWD
  • Data derived from real world sources can be used to support regulatory decisions

Overview:

  • Regulatory Context in Which RWE May be Used: General  considerations,  Application of IDE Requirements
  • Characteristics of RWD:  Relevance,  Reliability (Data accrual, Data assurance)
  • Examples Where RWE is Used
    • Expanded Indications for Use
    • Postmarket Surveillance Studies
    • Post-Approval Device Surveillance as Condition of Approval
    • Control Group
  • Supplementary Data
  • Objective Performance Criteria and Performance Goals

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Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

Background and Scope:

  • Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices as well as other technology
  • Potential to increase efficiency in patient care
  • Promote development and availability of safe and effective interoperable
    medical devices

Overview:

  • Design Considerations for Interoperable Medical Devices
    • Purpose of the Electronic Interface
    • Anticipated Users.
    • Risk Management Considerations
    • Verification and Validation Considerations
    • Labeling Considerations
    • Use of Consensus Standards
  • Recommendations for Contents of Pre-market Submissions
    • Device Description
    • Risk Analysis
    • Verification and Validation
    • Labeling

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Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

Background and Scope:

  • Improve data quality, consistency, transparency regarding  device performance within specific age, racial, and ethnic groups
  • Can benefit patients, clinicians, researchers, regulators, and others
  • Recommendations to overcome barriers to enrollment

Overview:

  • FDASIA: Considerations for age-, race- and ethnicity-specific differences
    • Participation of subgroups in clinical trials.
  • Recommendations for Appropriate Enrollment
    • Study Design, Early Enrollment Stage
    • Premarket Submission Stage
    • Postmarket Submission Stage
  • Planning for Diverse Study Recruitment
    • Study Design, Early Enrollment Stage
    • Premarket Submission Stage
    • Postmarket Submission Stage
  • Considerations for Study Follow-Up Visits
  • Interpretation of Study Results
  • Assessing Heterogeneity Across Subgroups
  • Recommendations for Subgroup Specific Statistical Elements
  • Recommendations for Submissions to Agency

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