Pre-Conference Workshops

Workshop A – FDA Device Law 101: Introduction to the Fundamentals

Jul 26, 2017 1:00pm – 4:00pm

Speakers

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

Workshop B – Resolving Ethical Challenges Encountered during the Device B Approval Process

Jul 26, 2017 4:15pm – 5:15pm

Speakers

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

Day 1 - Thursday, July 27, 2017

7:30
7:30 Registration and Continental Breakfast
8:10
Co-Chairs’ Opening Remarks: The New Administration and FDA Law
8:30
“Medical Devices” & FDA’s Regulatory Framework
9:30
FDA Keynote Address: Jonette Foy, Ph.D.
10:15
Morning Coffee Break
10:30
Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways
11:30
High-Risk Devices: Parsing the Premarket Approval Process (PMA)
12:30
Networking Luncheon
1:45
Examining the Implementation of the 21 Century Cures Act and the Effects for Medical Devices
2:30
Cybersecurity and Digital Health
3:30
Afternoon Refreshment Break
3:45
Understanding FDA Enforcement Tools, Policies, Practices, and Trends
4:45
Labeling, Promotion, Off-Label Communications, and First Amendment Concerns
5:45
Conference Adjourns to Day 2

Day 2 - Friday, July 28, 2017

7:45
Continental Breakfast
8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
Unique Considerations in the Approval of Combination Products and Companion Diagnostics
9:30
Quality Systems Regulation and UDI
10:30
Morning Coffee Break
10:45
Medical Device Reporting
12:00
Recalls and Withdrawals
12:45
Luncheon for Skills Session Participants

Post-Conference Workshop

Workshop C – Workshop Skills Session: Tips and Strategies for Communicating with FDA

Jul 28, 2017 2:00pm – 5:00pm

Speakers

Paulette M. Mara
Partner
Michael Best & Friedrich LLP (Washington, DC)

Nancy Stade
Partner
Sidley Austin LLP (Washington, DC)

Day 1 - Thursday, July 27, 2017

7:30
7:30 Registration and Continental Breakfast
8:10
Co-Chairs’ Opening Remarks: The New Administration and FDA Law

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)

Paulette M. Mara
Partner
Michael Best & Friedrich LLP (Washington, DC)

8:30
“Medical Devices” & FDA’s Regulatory Framework

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)

Nathan A. Beaver
Partner
Foley & Lardner LLP

  • 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

9:30
FDA Keynote Address: Jonette Foy, Ph.D.

Jonette Foy, Ph.D.
Associate Director for Policy (Acting)
Center for Devices & Radiological Health U.S. Food and Drug Administration

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.

10:15
Morning Coffee Break
10:30
Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways

Christopher Mikson, M.D.
Partner
Mayer Brown (Washington, DC)

Jeffrey Gibbs
Director
Hyman, Phelps & McNamara, PC (Washington, DC)

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.

11:30
High-Risk Devices: Parsing the Premarket Approval Process (PMA)

Yarmela Pavlovic
Partner
Hogan Lovells US LLP (San Francisco, CA)

  • 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

12:30
Networking Luncheon
1:45
Examining the Implementation of the 21 Century Cures Act and the Effects for Medical Devices

Paulette M. Mara
Partner
Michael Best & Friedrich LLP (Washington, DC)

  • 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
    Identifying software functions that are “reasonably likely to have serious adverse health consequences”

2:30
Cybersecurity and Digital Health

Stephen Lieb
Partner
Wissing Miller LLP (New York, NY)

Melissa Markey
Attorney
Hall, Render, Killian, Heath & Lyman, PLLC (Troy, MI)

Gretchen Vandal
Associate Director, Device Regulatory Affairs
Biogen Inc. (Cambridge, MA)

  • 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

3:30
Afternoon Refreshment Break
3:45
Understanding FDA Enforcement Tools, Policies, Practices, and Trends

Marian Lee
Partner
Gibson, Dunn & Crutcher LLP (Washington, DC)

Dan Kracov
Partner
Arnold & Porter Kaye Scholer LLP (Washington, DC)

  • 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

4:45
Labeling, Promotion, Off-Label Communications, and First Amendment Concerns

Scott Danzis
Partner
Covington & Burling LLP (Washington, DC)

Julie Tibbets
Partner
Alston & Bird LLP (Washington, DC)

  • 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”

5:45
Conference Adjourns to Day 2

Day 2 - Friday, July 28, 2017

7:45
Continental Breakfast
8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
Unique Considerations in the Approval of Combination Products and Companion Diagnostics

Nancy Stade
Partner
Sidley Austin LLP (Washington, DC)

  • 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

9:30
Quality Systems Regulation and UDI

Tricia Kaufman
Of Counsel
Stinson Leonard Street LLP (Minneapolis, MN)

Brian Malkin
Counsel
Arent Fox LLP (Washington, DC)

  • 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

10:30
Morning Coffee Break
10:45
Medical Device Reporting

Kevin Madagan
Partner
Reed Smith LLP (Washington, DC)

Stephanie Philbin
Counsel
Goodwin Procter LLP (Washington, DC)

Stephen Terman
Principal
Olson Frank Weeda Terman Matz, PC (Washington, DC)

  • 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

12:00
Recalls and Withdrawals

Amanda Klingler
Partner
King & Spalding LLP (Washington, DC)

Frederick A. Stearns
Partner
Keller and Heckman LLP (Washington, DC)

  • 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

12:45
Luncheon for Skills Session Participants

Workshop A – FDA Device Law 101: Introduction to the Fundamentals

Jul 26, 2017 1:00pm – 4:00pm

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

What is it about?

This workshop, tailored for professionals who have limited or no experience working with FDA on medical device regulatory matters, provides a basic overview of FDA device regulations. Topics addressed during this workshop will set the stage for the main conference by helping attendees thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, and postapproval process. Get the background you need to flow seamlessly into the more in-depth discussions that will take place throughout the conference. Topics include:
  • Introduction to FDA
  • History of FDA and device regulations
  • The Basics of Device Classification and FDA’s Review Process
  • Clinical Trials Process (IDEs)
  • Premarket Approvals (PMAs)
  • 510(k) Clearance Process
  • Labeling: Key Regulatory Requirements, Information, and Concepts
  • Post-Market Issues and Enforcement
  • Recalls and Withdrawals
  • Recent Developments at FDA

Workshop B – Resolving Ethical Challenges Encountered during the Device B Approval Process

Jul 26, 2017 4:15pm – 5:15pm

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

What is it about?

This one-hour ethics session will cover common ethical issues that arise while communicating with FDA during the approval process. The session will address various scenarios that raise questions on the extent of disclosure of adverse information such as:  
  • Scenario 1: 21 C.F.R. 10.30 requires a petitioner to certify that a citizen petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. This session will address the implications of this certification on an attorney in light of Rules 1.6, 1.7, and 1.8 of the Rules of Professional Responsibility.
  • Scenario 2: In the context of a Medical Devices Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. This segment will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
  • Hypothetical: Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending 510(k). This segment will cover the implications of Rule 1.11.

Workshop C – Workshop Skills Session: Tips and Strategies for Communicating with FDA

Jul 28, 2017 2:00pm – 5:00pm

Paulette M. Mara
Partner
Michael Best & Friedrich LLP (Washington, DC)

Nancy Stade
Partner
Sidley Austin LLP (Washington, DC)

What is it about?

Learn from our FDA experts as they lead you through the submission process demonstrating strategic practices and tips for each step, from the initial decision of choosing the best pathway, to creating an open communication with FDA along the way. This interactive workshop will provide practical guidance for building a positive working relationship with FDA, which is the key foundation to meaningful success with the Agency.