Day 1 - Wednesday, July 20, 2016

1:00
Pre-Conference Primer: Fundamentals of FDA Regulatory Device Law

Day 2 - Thursday, July 21, 2016

7:00
Registration & Continental Breakfast
7:45
Co-Chairs’ Opening Remarks
8:00
Overview of Device Regulation
8:45
Understanding FDA Enforcement Tools, Policies, Practices, and Trends
9:45
Morning Coffee Break
10:00
FDA Keynote: Postmarket Benefit: Risk, A Proposed Approach to Making Compliance and Enforcement Decisions for Medical Devices
10:30
Low to Moderate-Risk Devices – Clarification of the 510(k) Clearance and Dissecting the De Novo Classification
11:30
High-Risk Devices – Parsing the Premarket Approval Process (PMA)
12:30
Networking Luncheon
1:30
The First Amendment and Off-Label Enforcement: Understanding the Impact of the Caronia/Amarin/Pacira/ Vascular Solutions Cases on the Medical Device and FDA-Related Industries
2:30
Digital Health
3:45
Afternoon Refreshment Break
4:00
Refurbishment and Reusable Devices
4:45
Unique Device Identification (UDI)
5:45
Conference Adjourns to Day Two

Day 3 - Friday, July 22, 2016

7:45
Continental Breakfast
8:35
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
Quality System Regulation
9:45
Medical Device Reporting
10:45
Morning Coffee Break
11:00
Recalls and Withdrawals
12:00
Labeling and Promotion
1:00
Conference ConcludesLunch for Master Class Participants
2:00
Post-Conference Master Class: Deep Dive into the Unique Regulatory Schemes for Specialized Devices: IVDs, LDTs, Companion Diagnostics, and Combination Products

Day 1 - Wednesday, July 20, 2016

1:00
Pre-Conference Primer: Fundamentals of FDA Regulatory Device Law

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

Aimed at providing a primer to professionals who have limited or no experience working with FDA on medical device regulatory matters, this workshop provides a basic overview of FDA device regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and walking you through the preapproval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp –Devices Edition.

Topics to include:

  • Introduction to FDA: Mission and Organization
  • History of FDA Device Laws
  • Acronyms, Terminology, and Definitions
  • Basic FDA Concepts
  • The Basics of Device Classification
  • Understanding how CDER and CBER Intersect with CDRH
  • Defining the Scope of FDA’s Jurisdiction
  • Clinical Trials Process (IDEs)
  • Premarket Approval (PMA)
  • 510(k) Clearance Process
  • The Review Process
  • Labeling: Key Regulatory Requirements, Information, and Concepts
  • Post-Market Issues and Enforcement
  • Recent Developments at FDA- Regulations and Guidance, Enforcement Initiatives, Product Clearances/Approvals
  • Recalls

Resolving Ethical Challenges Encountered During the Device Approval Process

This one-hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios in which FDA requires full disclosure of adverse information and authority. For example:

  • In the context of citizen petitions, FDA requires certification that the 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. 21 CFR 10.30. This segment will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7, and 1.8 of the Rules of Professional Responsibility.
  • 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.
  • 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.

​1:00 p.m. – 5:00 p.m. (Registration begins at 12:30 p.m.)

Day 2 - Thursday, July 21, 2016

7:00
Registration & Continental Breakfast
7:45
Co-Chairs’ Opening Remarks

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

8:00
Overview of Device Regulation

David Rosen
Partner
Foley & Lardner LLP

  • Navigating 21 CFR part 800, et seq.
  • What is a device and how is it different from a drug?
  • Understanding the concept of risk-based classification and the three main classes (I, II, and III) of medical devices
  • 513(g) Requests
  • Combination Products
    • Definition
    • Process for designations
    • Options for seeking a combination product
    • How to get the correct classification for a product
    • Implications of getting a product classified as a device or a drug
  • Registration and listing
    • Who must register and submit a device list and what information must be included?

8:45
Understanding FDA Enforcement Tools, Policies, Practices, and Trends

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare

Daniel A. Kracov
Partner
Arnold & Porter LLP

  • Enforcement Overview – What FDA Can Do & Players Beyond FDA
  • FDA Compliance & Enforcement Mechanisms & Best Practices
    • Inspections
    • EIRs
    • Form FDA 483 Observations
    • Untitled & Warning Letters
      • Inspection-related
      • Based on other data & information
    • Imports & Exports
    • Civil Seizure
    • Injunction
    • Civil Money Penalties
    • Criminal Prosecution
  • Current Key Areas of Focus for CDRH
  • Enforcement Trends: FDA, Park Doctrine, DOJ & OIG

9:45
Morning Coffee Break


Pathways to Approval

10:00
FDA Keynote: Postmarket Benefit: Risk, A Proposed Approach to Making Compliance and Enforcement Decisions for Medical Devices

Robin Newman MSN EdD
Director, Office of Compliance
CDRH

10:30
Low to Moderate-Risk Devices – Clarification of the 510(k) Clearance and Dissecting the De Novo Classification

Jeffrey Senger
Partner
Sidley Austin

Jeffrey Gibbs
Director
Hyman, Phelps & McNamara, PC

This session is a ready-to-use strategic primer covering the 510(k) clearance and de novo pathways. The presentation will begin by highlighting the key components of the clearance process and providing practical information for getting to market. Next will be a discussion of 510(k) at the FDA, including current and forthcoming changes to the process. After that will be a discussion of the de novo pathway and when it is appropriate. Finally, the session will provide practical guidance to building a positive working relationship with FDA which, other than your product, is the key foundation to meaningful success with the Agency.

  • Overview of the clearance process
    • Regulatory requirements 21 CFR part 807
    • Premarket notification procedures
      • Importance of strategy and predicate devices
      • Pre-submission process
      • Drafting a 510(k) application
    • What is the review process?
      • Through FDA’s eyes
      • Substantial equivalence determinations
      • Information about safety and effectiveness
      • Not Substantially Equivalent determinations and recourse
  • Regulatory Changes to the 510(k) Process- What to Expect Going Forward
    • Changes and modifications to legally-marketed class I and class II devices- When to file a new 510(k)
    • What to do after modification of a previously-exempt device?
  • Dissecting De Novo Classification
    • When is the de novo pathway appropriate?
    • Presubmission Process- when to use it
    • Classification of the device and effect on next comers
  • Working Successfully with FDA
    • Best practices
    • Building and maintaining a positive working relationship with FDA
    • Institutional reputation
    • Deciding how and when to appeal

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

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Kristin Zielinski Duggan
Senior Associate
Hogan Lovells US LLP

  • What devices are subject to the PMA process?
    • Pre-amendment devices/Rulemaking
    • Post-amendment devices/Order
    • Novel high risk devices
  • Navigating the PMA application process
    • Pre-Submission Process
    • Submission
    • Amendments
    • Timing
    • Expedited Access Pathway for unmet medical needs for life threatening or irreversibly debilitating diseases or conditions
      • Goal of reducing time and costs from development to market
      • Deciding when to choose the EAP pathway
  • FDA action on a PMA
    • Timing
    • Filing decision
    • Day 100 meeting
    • Panel
    • Decision
    • Post-approval requirements
      • post-market surveillance
  • Understanding Clinical Trials and Investigational Device Exemption (IDE)
    • When does FDA require clinical data
    • Early feasibility studies and when to use them
    • When is an IDE required and what is the process for obtaining approval?
    • Regulatory requirements
      • Labeling of investigational devices
      • Prohibition of promotion and other practices
      • IRB review and approval
      • Investigator obligations
      • Records and reports
  • Humanitarian Use Devices
    • HDE applications and amendments
    • Institutional Review Board requirements
    • Post-approval requirements and reports
  • Deciding how and when to appeal

12:30
Networking Luncheon


Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Trends that Impact FDA Practice

1:30
The First Amendment and Off-Label Enforcement: Understanding the Impact of the Caronia/Amarin/Pacira/ Vascular Solutions Cases on the Medical Device and FDA-Related Industries

Mona Patel
Partner
Covington & Burling LLP

Michael Pauze
Partner
King & Spalding LLP

  • Background and update on the cases
  • How are these cases affecting FDA’s ability to regulate what companies can say?
  • What is FDA doing? What is Congress doing?
  • Will these cases really destroy FDA’s pre-approval authority?
  • What are the next steps to take based on the current status of the cases?

2:30
Digital Health

Mauricio Paez
Partner
Jones Day (New York, NY)

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)

Ed Daniels
VP Ethics and Compliance
Cardinal Health

  • Crossing the border- Examining when software becomes a medical device
  • Mobile medical applications and FDA’s guidance
    • New mobile health app interactive tool
  • Navigating the review process
  • Cybersecurity challenges when dealing with medical device software and intercommunication between devices
  • Enter Sandman- FTC dealing with emerging privacy concerns

3:45
Afternoon Refreshment Break
4:00
Refurbishment and Reusable Devices

James R. Ravitz
Partner
Arent Fox LLP

  • Address concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to servicing, refurbishing, rebuilding, reconditioning, remarketing, or remanufacturing.
  • Maintaining market share for new products while being threatened by third-party refurbishers
  • Reusable medical devices such as duodenoscopes- sterilization and crosscontamination concerns and public health issue

4:45
Unique Device Identification (UDI)

Linda Chatwin
Manager Medical Regulatory Advisory Services
UL LLC

Jackie Elkin
Global Process Owner - Standard Product Identification
Medtronic Inc.

  • What to do, how to do it, are your devices subject to UDI requirements?
  • Software and other “virtual” devices, what type of UDI is required?
  • Class 2 compliance as of September 2016
  • How to reshape systemic activities within your organization in order to comply with UDI requirements

5:45
Conference Adjourns to Day Two

Day 3 - Friday, July 22, 2016

7:45
Continental Breakfast
8:35
Co-Chairs’ Opening Remarks and Recap of Day One

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)


Complying with General Post-Market Controls

8:45
Quality System Regulation

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Monica Wilkins
Divisional Vice President
Abbott Quality & Regulatory

  • Statutory requirements
  • 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)

9:45
Medical Device Reporting

Stephanie Philbin
Counsel
Goodwin Procter (Washington, DC)

Stephanie Wasielewski
VP RA/QA
Corpak MedSystems, Inc.

  • Handling of complaint files
  • What is reportable?
  • Generally applicable requirements for individual adverse event reports
  • Requirements for developing, maintaining, and implementing written MDR procedures, files, and records
  • Exemptions, variances, or alternative forms of adverse event reporting requirements
  • What information from the reports is disclosed to the public?
  • Does the information in my report constitute an admission that the device caused or contributed to the reportable event?
  • Common errors and how to avoid them
  • Identifying the latest trends in MDR
  • Warning letters or 483s at the end of an inspection
  • Hypotheticals

10:45
Morning Coffee Break
11:00
Recalls and Withdrawals

Joseph Falvo
Sr. Manager Post-Market Risk Management
Ortho-Clinical Diagnostics

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

  • How are device recalls different from drug recalls?
  • What medical device recalls must be reported to FDA?
  • FDA’s recall and oversight authority
    • 21 CFR part 7
    • Voluntary vs. mandatory recalls
    • 21 CFR part 810 – Mandatory Medical Device Recall Procedures
      • Cease distribution and notification order
      • Regulatory hearing
      • Mandatory recall order
      • Termination of a cease distribution and notification or mandatory recall order
      • Public notice
    • Part 806, Corrections and removals reporting
    • When should a company institute a recall?
      • Can new labeling or new product warning constitute a recall?
    • When should the decision be made to work with FDA?
      • Working with FDA vs. working alone
      • Risks and benefits of each course of action
    • Consequences of not instituting a recall
    • FDA seizure and injunction power
    • Post-recall surveillance issues
    • Reintroducing a product to the market

12:00
Labeling and Promotion

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

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

  • Jurisdiction and definitions
    • 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
    • FTC Guidance, “.com Disclosures”
  • FDA Regulation of Promotion
    • Introduction to FDCA requirements for promotion (misbranding, adulteration)
    • What is off-label?
    • Promotion for various device types: exempt, 510(k), PMA devices
    • Standards for substantiation
    • Risk disclosure
    • Advertising for restricted devices
    • SEC considerations, talking to the press, and cautionary tales
    • What can you say and where?
      • Social Media
      • Draft FDA Guidance “Distributing Scientific and Medical Publications on Unapproved New Uses”
      • Disease awareness activities
  • Enforcement
    • Enforcement trends in device promotion

1:00
Conference ConcludesLunch for Master Class Participants
2:00
Post-Conference Master Class: Deep Dive into the Unique Regulatory Schemes for Specialized Devices: IVDs, LDTs, Companion Diagnostics, and Combination Products

This master class builds on content covered during the main conference, and delves deeper into specific issues that face practitioners dealing with unique regulation of special devices. Your leaders will provide you with enhanced information specific to in vitro diagnostics, laboratory developed tests, companion diagnostics, and combination productsproducts that are classified as medical devices and will help you thoroughly comprehend the complexities and nuances of these areas of regulatory law

In Vitro Diagnostics, Laboratory Developed Tests, and Companion Diagnostics, Oh My!

  • Understanding FDA’s regulation of in vitro diagnostics (IVDs), including:
    • premarket pathways, including premarket notifications and premarket applications
    • data requirements
    • labeling and promotion
    • research use only (RUO) and investigational use only (IUO) products
    • postmarket requirements
  • Understanding the evolving regulatory landscape for laboratory developed tests:
    • What is a laboratory-developed test (LDT)?
    • Determining whether FDA will regulate an LDT as a medical device or continue to exercise enforcement discretion
    • Challenges for clinical laboratories subject to FDA regulation for the first time
  • Personalized medicineand companion diagnostics
    • What are companion diagnostics?
    • FDA’s regulatory paradigm for companion diagnostics
    • Agency recommendations for developers of companion diagnostics

Unlocking the Combination: Decoding the Unique Challenges of Combination Products

  • Choosing the best submission approach for your product
    • Determining which center has priority
    • Application approaches – single or separate submissions?
  • Developing a robust submission strategy
    • Navigating the regulatory landscape and expectations
    • Design Control considerations
    • Obtaining and managing feedback from regulators
    • Submission content considerations
  • Managing change management
    • Correlating submission content and change management obligations
    • Understanding and evaluating changes
    • Practical approaches to regulatory assessment
  • Overcoming the regulatory and compliance challenges that arise with combination products
    • Recommendations for avoiding some common pitfalls
    • Staying current in the evolving combination product space
    • Case studies – exploring scenarios and solutions

​2:00 p.m. – 5:00 p.m.