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Critical Issues facing Medical Devices in 2020

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Boston, MA 02108

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2 Day in-person Seminar by former FDA Director, Casper Uldriks: Critical issues facing Medical Device in 2020: Pre-market pathways; MDR & MDSAP Implementation; Marketing Off Label Use

Seminar Overview

The FDA’s device regulation has begun to make your regulatory life easier. Can you qualify for an easier way of life under FDA regulation? Getting to market with a new device could be totally under your control and keep FDA out of the premarket hurdle. On the other hand, the EU’s new regulation will make it more difficult. How can you prepare for that? What does it mean for FDA’s regulatory plans and your marketing roll out for new products? One disaster remains hidden and will be costly if you do not plan for it. The new EU Medical Device Regulation (MDR) affects U.S. firms that export devices to the EU. The MDR imposes many new requirements, one of which is the mandatory renewal of your exported device’s CE mark every ten years. This means that life cycle programs for devices will change. How will this impact your regulatory compliance?

These are questions you should be able to answer to adequately your firm for 2020, not just in the U.S. but in the EU as well.

Learning objectives

  • Identify applied qualifications for 510(k) self-certifications

  • Explain global inspections per FDA 13485

  • What to expect for EU inspections by a Notified Body

  • Changes in FDA’s regulation of software and cybersecurity threats

  • Identify the impact of the EU’s MDR on U.S. device exports

  • Explain the role of Affirmation of Compliance submissions for imports

  • Analysis off-label marketing and intended use parameters


Casper Uldriks, ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.


Session Agenda

September 19, 2019

8:30 a.m. – 9:00 a.m.

  • Registration, personal introductions and morning refreshments

9:00 a.m. – 10:30 a.m.

  • Current FDA statutory requirements and device regulatory program changes
  • FDA premarket and postmarket initiatives

Premarket

  • Self-certification for software and class II devices (EU MDR 2020)
  • Voluntary standards (abbreviated premarket submissions) (FDA)
  • Premarket inspection priorities (FDA)

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Premarket continued

  • EU 10-year premarket renewal requirement for devices
  • Impact of new MDR clinical study reporting requirements on foreign IDE clinical sites

12:00 p.m.—1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

Postmarket

  • Unified U.S., EU and Canada inspection program
  • Tougher postmarket reporting for adverse events (EU and FDA)
  • FDA software, software-based devices and mobile apps

2:30 p.m.—2:45 p.m.

Break

2:45 p.m.—4:30 p.m.

Postmarket (continue)

  • FDA software, software-based devices and mobile apps
  • Cybersecurity oversight and voluntary standards

4:30 p.m.—5:00 p.m.

Discussion, Q&A

September 20, 2019

9:00 a.m. – 10:30 a.m.

  • Export of devices from the U.S.
  • Export of unapproved PMA devices to the EU under MDR 2020
  • Export of 510(k) devices not cleared for marketing to the EU under MDR 2020
  • Export of approved PMA or cleared 510(k) devices
  • Coordination with “Tier 1” countries for global commerce

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 a.m.

  • Import considerations
  • Domestic and foreign marketing cautions
  • Affirmation of Compliance for U.S. entries and Prior Notice
  • Voluntary Qualified Import Program (VQIP)
  • Detentions and Refusals

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

  • Off-label determinations of intended use and off-label intended use
  • Intended use creep (incremental expansion) and indications for use
  • FDA determination for acceptable vs. unacceptable claims for intended use
  • Contradictory labeling prohibitions (Where you are located makes a difference.)
  • Off-label device distribution

2:30 p.m. – 3:00 p.m

Discussion and Q & A


Who should attend?

This Huddle Seminar is designed for all Medical Device manufacturers. All MedTech Startup company exploring product pathways.

  • Product VP, Director
  • Regulatory Affairs Directors
  • Quality Assurance Managers
  • Quality Control Managers
  • Manufacturing Directors and Managers
  • Product Risk Managers
  • Venture Capitalists
  • Medtech Startups
  • CEOs and Founder, MedTech
  • Domestic device manufacturers
  • Design engineers
  • Business planning executives
  • Foreign and domestic regulatory affairs managers
  • Quality assurance managers – foreign and domestic inspections
  • Logistics managers
  • Manufacturers of exported devices
  • Export Distributors
  • Initial importers
  • Import Logistics Managers
  • Foreign Manufacturers
  • U.S. Manufacturers
  • Import-for-export Manufacturers
  • Sales and marketing directors
  • Customs Brokers


Participation FEE includes -

  1. Certificate of Completion
  2. Recording of the event
  3. One year memebrship of Plianced with hundreds of additional content

We hope to see you at the event!

Huddle Seminar Team

Plianced Inc.

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Date and Time

Location

WeWork

One beacon st

Boston, MA 02108

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Refund Policy

Contact the organizer to request a refund.

Eventbrite's fee is nonrefundable.

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