Explore the essentials of device law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, Premarket Approval Application, advertising and promotion, compliance, enforcement and related issues. Case studies, hypotheticals, and ample time for Q&A is provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for medical devices
  • How to prepare a successful 510(k) submission
  • Registration and listing requirements
  • Elements of conducting clinical investigations
  • Premarket Approval Application (PMA) and approval process
  • Post-marketing requirements
  • FDA’s enforcement tools and procedures
  • Advertising and promotion requirements
  • Quality System Regulation (QSR)

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Radiation Control for Health and Safety Act of 1968 (RCHSA)
  • 1976 Medical Device Amendment
  • Safe Medical Devices Act of 1990 (SMDA)
  • Mammography Quality Standard Act of 1992 (MQSA)
  • Food and Drug Administration Modernization Act of 1997 (FDAMA)
  • Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of device law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

Register

Industry & Firms

$1199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Wednesday, April 26

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–10:15 AM
Overview of Medical Device Law and Regulation

Jacqueline Chan, Associate, Kleinfeld, Kaplan & Becker, LLP

10:15–10:30 AM
Networking and Refreshment Break

10:30 AM–12:00 PM
Premarket Notification 510(k)

Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC

12:00–1:30 PM
Networking Lunch

1:30–2:00 PM
Registration and Listing

Carolina Wirth, Counsel, Kilpatrick Townsend & Stockton LLP

2:00–3:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs) and informed Consent

Mahnu Davar, Partner, Arnold & Porter Kaye Scholer LLP

3:00–3:15 PM
Refreshment and Networking Break

3:15–4:10 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues

Mahnu Davar, Partner, Arnold & Porter Kaye Scholer LLP

4:10–5:00 PM
Premarket Approval Application (PMA)

Kristin Zielinski Duggan, Counsel, Hogan Lovells LLP

5:00–6:00 PM
Networking Reception

Thursday, April 27

8:00–8:30 AM
Continental Breakfast

8:30–9:20 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

Preeya Noronha, Attorney, Latham & Watkins LLP

9:20–10:40 AM
Post Marketing Issues

Christina Kuhn, Senior Associate, Covington & Burling LLP

10:40–10:55 AM
Refreshment and Networking Break

10:55 AM–12:00 PM
Enforcement and Compliance

Brandon Moss, Associate, Wiley Rein LLP

12:00–1:00 PM
Networking Lunch

1:00–2:45 PM
Promotion and Advertising

Paul Gadiock, Senior Attorney, Arent Fox LLP

2:45–3:00 PM
Networking and Refreshment Break

3:00–4:15 PM
Quality System (QS) Regulation

Abram Barth, Senior Associate, Ropes & Gray LLP

4:15–5:00 PM
International Issues

John Johnson, III, FDAImports.com, LLC

5:00 PM
Adjournment

Speaker Biographies

ABRAM BARTH is an associate at Ropes & Gray in the life sciences and health care practice groups since 2015. Abram has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices, combination products, and clinical research.  Previously, Abram worked in the Food and Drug Administration’s Office of Chief Counsel, most recently as Associate Chief Counsel, serving as Team Leader of the device practice group.  He has significant experience advising clients on the life cycle of medical devices, including clinical trials, premarket submissions, advertising and promotion, quality system regulation, medical device reporting, and postmarket surveillance and studies, as well as the premarket and postmarket regulation of combination products. In addition, Abram was a principal attorney advising the FDA and HHS on clinical research compliance and policy, and served as counsel to FDA’s IRB. He has been recognized with numerous awards at FDA.

JACQUELINE CHAN is an associate at Kleinfeld, Kaplan & Becker LLP.  She counsels FDA-regulated companies on issues throughout the product lifecycle, including labeling, promotion, enforcement risk assessment, post-marketing obligations, and regulatory strategy and compliance.  Her practice also includes FDA due diligence investigations for transactional matters involving FDA-regulated company acquisition and divestment.  Ms. Chan currently serves on the Editorial Advisory Board of the Food and Drug Law Institute’s Update magazine.

MAHNU DAVAR is a partner at Arnold & Porter Kaye Scholer Washington, DC office.  His practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces.  Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations. He has also assisted clients to prepare for and navigate state and federal regulatory inspections. Mr. Davar’s practical approach to counseling in these areas is informed by his experience working first-hand with business leaders as a “secondee” in the legal departments of several leading multinational drug and device companies.  Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India. Prior to joining the firm, Mr. Davar worked as a law clerk at Wyeth Pharmaceuticals.

KRISTIN ZIELINSKI DUGGAN is counsel at Hogan Lovells LLP Washington, DC office.  With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and FDA regulatory challenges, while always keeping business needs in mind. For the past 17+ years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products.  Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years — including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels — Kristin is a top thought leader in this area.

PAUL GADIOCK is a senior attorney at Arent Fox LLP in the Food, Drug, Medical Device & Agriculture Practice. He provides premarket and postmarket regulatory solutions on a variety of subject matters for medical device clients. As a former policy director at FDA, Paul brings first-hand experience with major regulatory programs and frameworks.

JOHN JOHNSON is a senior associate attorney at Benjamin L. England & Associates.  John represents and advocates for clients with FDA-regulated commodities before FDA over a variety of issues, including Warning and Untitled Letters, 483 Observations, import detentions and import alerts. He also counsels and advises clients with labeling, marketing, formulation, and manufacturing compliance, and guidance clients on building in-house compliance capacity.

CHRISTINA KUHN is an Associate at Covington & Burling LLP, advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters.  She has experience with cutting-edge medical device technologies, including digital health products, diagnostics, and combination products.  Ms. Kuhn helps companies navigate the premarket regulatory process, advising clients on regulatory classification, clinical development strategy, and agency interactions.  She counsels clients on postmarket compliance requirements and responses to enforcement actions, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls.  She also regularly assists clients in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.  Ms. Kuhn’s wide range of clients includes software companies, multinational device and pharmaceutical companies, industry associations, and development-stage companies.  She is also a frequent contributor to Covington’s Inside Medical Devices and Digital Health blogs.

BRANDON MOSS is an associate at Wiley Rein.  Brandon represents corporate and individual clients in government and internal investigations, civil and regulatory enforcement matters, and other litigation. She also advises a broad range of companies on privacy, telecommunications, compliance, Team Telecom, and new media issues.

PREEYA NORONHA PINTO is a partner in the FDA & Life Science Practice Group in King & Spalding’s Washington, DC office, where she designs and executes reimbursement strategies for pharmaceutical and medical device manufacturers, and engages in regulatory and policy advocacy before HHS and the Congress. Previously, Ms. Pinto served as Acting General Counsel of HHS, where she was legal advisor to the Secretary of Health and Human Services and supervised an office of more than 500 attorneys responsible for providing legal advice to the entire Department, including CMS and FDA.  Prior to her service at HHS, Ms. Pinto practice constitutional and administrative law at DOJ, where she was twice awarded the Attorney General’s Award for Distinguished Service.  Ms. Pinto graduated with honors from Columbia Law School and the Georgetown University School of Foreign Science.

JEFFREY SHAPIRO is director at Hyman, Phelps & McNamara, PC. He has specialized in medical device law, advising and representing companies for more than 20 years. Experienced in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters, he counsels clients on FDA requirements governing IVDs and HCT/Ps. Mr. Shapiro is an expert in FDA’s regulation of combination products, including preparation of RFDs. As an advisor to an array of medical device manufacturers, he recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies. Mr. Shapiro is a member of the Editorial Advisory Board for MDDI and Update magazines, and co-editor of two textbooks, Promotion of Biomedical Products (Food and Drug Law Institute, 2006) and Combination Products, How to Develop the Optimal Strategic Path for Approval (FDA News 2005).

CAROLINA WIRTH is counsel in Kilpatrick Townsend’s Washington, DC office.  She focuses her practice on product regulation matters primarily in the life sciences industry.  Ms. Wirth has experience providing regulatory counseling on food, drugs (human and veterinary), biologics, cosmetics, and medical devices to both domestic and international clients.  She also advises clients on compliance issues associated with the labeling, packaging, and advertising of foods, over-the-counter (OTC) drugs, cosmetics, and dietary supplements.  Prior to joining the firm, Ms. Wirth served as Senior Vice President for Regulatory Affairs at a veterinary regenerative medicine company in Middleburg, Virginia.  Ms. Wirth also served as Regulatory Counsel in the Office of Regulatory Policy of the FDA’s Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.  Ms. Wirth earned her JD from Boston University School of Law.

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Virginia: 13.0 CLE credit hours
Pennsylvania:  13.0 CLE credit hours

Location and Overnight Accommodations

Course Location

Arent Fox LLP
1717 K St NW
Washington, DC 20036

Overnight Accommodations

Hyatt Place, 1522 K Street NW
Capital Hilton, 1001 16th Street NW
The Mayflower Hotel, 1127 Connecticut Avenue NW
Hotel RL, 1823 L Street NW

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.