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

FDA BRIEF: Week of November 7, 2016

For: Reporting and record-keeping requirements

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

Scope:

• 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

General

• 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

Inclusion

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

Communication

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

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

To: Provide general study design considerations

Overview:

• 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

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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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