7:30 Registration and Continental Breakfast

Co-Chairs’ Opening Remarks: The New Administration and FDA Law

“Medical Devices” & FDA’s Regulatory Framework

• What is a “Device”?
• Differentiating medical devices from drugs and non-medical devices
• The 3 risk-based classes of medical devices
• Overview of FDA regulation of devices & paths to market for devices
• Understanding combination products: definitions, processes, strategies & implications
• Working with FDA’s Center for Devices & Radiological Health
• Office of Regulatory Affairs realignment

FDA Keynote Address: Jonette Foy, Ph.D.

We are honored that Jonette Foy, Ph.D., Acting Associate Director for Policy at the Center for Devices and Radiological Health, FDA will present the keynote address and provide us with an update on latest developments at FDA.

Morning Coffee Break

Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways

This session is a ready-to-use strategic primer covering the 510(k) clearance and de novo pathways, the key components of each one, and practical tips for successfully working through each process to get to market. The panel will discuss the current and future changes for the 510(k) process at the FDA, and when the de novo pathway is appropriate.

High-Risk Devices: Parsing the Premarket Approval Process (PMA)

• Determining eligibility for PMA
•  Navigating through the steps of the PMA process
  • Pre-Submission and Pre-PMA processes
  • Original PMA Submission
  • Planning for Day 100 Meetings
  • Amendments and responding to Agency Deficiencies
  • PMA Decision
  • Withdrawal of approval/temporary suspension of PMA approval
  • Post-approval requirements
•   Other Considerations
  • Expedited Access Pathway for unmet medical needs for life threatening or irreversibly debilitating diseases or conditions
  • Priority Review
• Understanding Clinical Trials and Investigational Device Exemption (IDE)
• Humanitarian Use Devices
  • HDE applications and amendments
  • Denial of approval or withdrawal of approval of an HDE

Networking Luncheon

Examining the Implementation of the 21 Century Cures Act and the Effects for Medical Devices

• Expedited Review Process for Breakthrough Devices
  • Broadening the use of expedited review to include 510(k) and de novo pathways
• Expanding the use of the Humanitarian Device Exception (“HDE”)
• Clarifying Medical Software Regulation
  • Reviewing the classes of software excluded from device classification

Cybersecurity and Digital Health

• Determining when software is classified as a medical device and navigating the review process
• Reviewing FDA’s “Postmarket Management of Cybersecurity in Medical Devices” Guidance
• Best practices for mitigating and controlling cybersecurity threats while maintaining patient safety and product performance
  • Controlling cybersecurity threats arising with intercommunication between devices
• The world of mobile medical applications
• Maintaining compliance with FTC’s data security requirements

Afternoon Refreshment Break

Understanding FDA Enforcement Tools, Policies, Practices, and Trends

• Enforcement Overview- Identifying the players and their positions
• Reviewing FDA Compliance and Enforcement Mechanisms and Best Practices
  • Inspections
  • EIRs
  • Form FDA 483 Observations
  • Untitled and Warning Letters
    • Related to inspections
    • Resulting from non-inspection data or information
  • Imports and Exports
• Understanding potential punishments including civil seizure, injunction, civil money penalties, and criminal prosecution
• Current Trends and Key Areas of Focus for CDRH

Labeling, Promotion, Off-Label Communications, and First Amendment Concerns

• FDA v. FTC regulation
  • Advertising v. labeling
  • Restricted devices, prescription devices, and OTC devices
• FTC Requirements for Advertising
  • Introduction to FTC Act
  • FTC requirements for substantiation of health claims
  • FTC requirements for endorsements
• FDA Regulation of Promotion
  • Reviewing FDA’s two recent Guidances on communications related to medical devices
    • “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities”
    • “Medical Product Communications That Are Consistent With the FDA-Required Labeling”
• Analyzing FDA’s position on First Amendment
  • Examining FDA’s “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

Conference Adjourns to Day 2

Continental Breakfast

Co-Chairs’ Opening Remarks and Recap of Day One

Unique Considerations in the Approval of Combination Products and Companion Diagnostics

• Companion diagnostics
  • The regulation of laboratory developed tests (LTDs)
  • In vitro diagnostic devices (IVDs) and Next
  • Generation Sequencing (NGS) IVDs
• Combination Products
  • What are the requirements for approval of combination products?
  • What is the regulatory pathway?
  • Request for designation process (RFD) and the newly-created pre-RFD process
  • Role of the Combination Product Policy Council

Quality Systems Regulation and UDI

• The Seven subsystems of the Quality Systems Regulation
  • Management Controls
  • Corrective Action and Preventive Action
  • Design Controls
  • Production and Process Controls
  • Materials Controls
    • supplier quality and design issues
    • third-party supplier programs
  • Facilities
  • Document Controls
• Quality Systems Inspection Technique (QSIT)
• Voluntary ISO 13485 Inspection Program
• International Medical Device Regulators Forum (IMDRF)
• Determining whether a device is subject to UDI
• Software and other “virtual” devices
• Update on Class 2 compliance
• How to reshape systemic activities within your organization in order to comply with UDI requirements

Morning Coffee Break

Medical Device Reporting

• Requirements for developing, maintaining, and implementing written MDR procedures, files, and records
• Handling intake of complaint files and determining what is reportable
• Generally applicable requirements for individual adverse event reports
• Exemptions, variances, or alternative forms of adverse event reporting requirements
• Identifying what information will be disclosed to the public
• Staying conscious of including admissions that the device caused or contributed to the reportable event
• Common errors and how to avoid them
• Identifying the latest trends in MDR

Recalls and Withdrawals

• Differentiating device recalls from drug recalls
• Evaluating FDA reporting requirements for device recalls
• Examining FDA’s recall and oversight authority
  • 21 CFR part 7
  • Voluntary vs. mandatory recalls
  • Seizure and injunction powers
  • 21 CFR part 810 – Mandatory Medical Device Recall Procedures
    • Cease distribution and notification order
    • Regulatory hearing
    • Mandatory recall order
    • Public notice
  • Part 806, Corrections and removals reporting
• Weighing the pros and cons of working with FDA vs. alone
• Consequences of not instituting a recall
• Post-recall surveillance issues
• Reintroducing a product to the market

Luncheon for Skills Session Participants