FDA Guidances: Medical Device Reporting, Patient Connection Program, Neurological Devices IDE, Botanical Product Review – Drug and Device Digest

FDA BRIEF: Week of November 7, 2016fda guidances


For: Reporting and record-keeping requirements

  • manufacturers of medical devices
  • device-related adverse events
  • malfunctions


  • Regulations and Basic Requirements
  • Manufacturer Reporting Requirements
  • Written Procedures, Recordkeeping and Public Disclosure
  • Specific Issues and Situations
  • Questions Concerning Completion of the MDR Report

Webinar: Nov 30th INFORMATION


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CDRH Patient & Care-Partner Connection program (P&CC)

  • tied to one of CDRH’s strategic priorities to “Partner with Patients
  • build upon efforts at conducting meaningful patient engagement
  • also committed to engaging with family or care-partners who are integral to patient care and disease management

Seeking comments from interested persons FDA-2016-N-3462


  • Potential barriers to inclusion
  • What can FDA do to avoid or remedy
  • Appropriate and effective FDA engagement
  • Title appropriateness “Patient and Care-partner Connection”; other suggestions


  • Appropriate organizations for partnership
  • Barriers to effective communication between FDA, partner organizations, patients, and care-partners
  • Approaches for FDA engagement with underserved, underrepresented communities


  • Appropriate  lines of questioning
  • Positively and/or negatively viewed characteristics
  •  Preferred methods or qualities of communication



For: Neurological medical devices designed to slow, stop, or reverse disease progression

To: Provide general study design considerations


  • Biological Markers and Clinical Endpoints : Biomarker Tests, Clinical Outcome Assessments
  • Trial Designs: Study Approaches and Limitations
  •  Investigational Plans
  • Safety
  • Benefit-Risk Considerations
  • Informed Consent Documents
  • Labeling : Indications for Use, Warnings and Precautions



For: IND/NDA review process for botanical drug products and role of Botanical Review Team (BRT)

To: Ensure review quality and consistency

General:  BRT designated member of review team, provides pharmacognosy review, participate in submission meetings

Application Reviews: Regulatory business project managers, BRT, CMC and biopharmaceutics team members, clinical pharmacology review, nonclinical pharmacologist/toxicologist, clinical reviewers from OND and the statistical reviewers

Postapproval Activities and Surveillance




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