Mark DuVal is conducting a 1-day preconference workshop - U.S. Regulatory Essentials - Medical Devices and IVDs.

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; advertising, labeling and promotional aspects; and post-market, compliance and enforcement requirements will be covered.

Featured Speaker:

Mark DuVal, J.D., FRAPS
President & CEO
DuVal & Associates

Registration & More

This hybrid session will address FDA regulatory law topics on Digital Health, including navigating topics related to clinical decision support, software functions, artificial intelligence/machine learning, and cybersecurity. Including, how Digital Health companies can stay outside the realm of FDA oversight. The session will also focus on recent Digital Health policy updates, including how Digital Health may impact an update to the medical device statutory scheme.

Featured Speakers from DuVal & Associates:

Aaron Hage, J.D.
Senior Director of Legal-Regulatory & Compliance

Bryan Feldhaus, J.D., LL.M.
Vice President of Legal-Regulatory and Compliance

Registration & More

Join Greenlight Guru, Velentium, Galen Data, and Minneapolis's top medical device quality, regulatory, clinical data, and engineering professionals for learning, networking, drinks, and hors d'oeuvres.

Featured Speakers:

Mark DuVal, J.D., FRAPS
President & CEO
DuVal & Associates

Howard Root
Chairman of the Board
Reprise Biomedical

Registration & More

This session will address FDA regulatory law topics on Digital Health, including navigating topics related to clinical decision support, software functions, artificial intelligence/machine learning, and cybersecurity. Including, how Digital health companies can stay outside the realm of FDA oversight. The session will focus on recent Digital health policy updates, including how Digital Health may impact an update ot the medical device statutory scheme.

Featured DuVal & Associates Speakers:

Bryan Feldhaus
Vice President of Legal-Regulatory and Compliance
DuVal & Associates

Aaron Hage
Senior Director of Legal-Regulatory & Compliance
DuVal & Associates

Registration & More

Ensuring compliance looks different depending on what phase you’re in (pre-market, post-market, or somewhere in between). That's why we're hosting a virtual summit with the primary goal of increasing your confidence in your journey through commercialization, no matter what product phase you are in.

Featured DuVal & Associates Speaker:

Mark DuVal, J.D., FRAPS
President & CEO
DuVal & Associates

Registration & More

This session will help medical devices/IVD RA professionals who are preparing for eSTAR device submissions to FDA. Two experienced medical device regulatory experts will share their learning lessons in making successful eSTAR submissions, including practical considerations they experienced. FDA staff responsible for the design and operation of the eSTAR program will join the session to answer questions and hear feedback from attendees. The goal of the session is to improve consistent understanding of eSTAR submissions and support RA professionals in the transition to this new FDA requirement for device submissions.

Featured DuVal & Associates Speaker:

Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering, DuVal & Associates

Registration & More

DuVal & Associates is presenting "Survivor: The FDA 510(k) Program Edition" a 2-day workshop at the RAPS Spring Workshop in Rockville, MD.
In the popular television series “Survivor,” contestants are left on an isolated island with the odds stacked against them; they fight for survival amid constantly changing rules. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance of being “the survivor.” Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to survive on the show. Unlike TV—there is plenty of room for more than one to survivor!
Join RAPS and your regulatory colleagues this spring as we offer a series of in-person, interactive educational and networking workshops. Taking place at RAPS Global Headquarters in Rockville, MD, close to the epicenter of our Nation's Capital!

Featured Speakers:

Mark DuVal, J.D.,FRAPS
President & CEO
DuVal & Associates

Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering
DuVal & Associates

Anike Freeman, PMP
Senior Regulatory Affairs Specialist
Thermo Fisher Scientific Inc.

Dongbo Wang, Ph.D.
Senior Director of Regulatory
Galvanize Therapeutics

Ken Skodacek
FDA/CDRH Deputy Ombudsman
FDA

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A brilliant design for a medical device means nothing if you can’t get it past the scrutiny of a regulatory body (e.g, FDA). This full day workshop will provide insights into the basics of medical device regulations to help you understand activities needed to bring a medical device to market and to successfully navigate the ever-increasing challenges of this exciting field.
Workshop sessions will include an introduction to US regulations and working with the FDA, conducting clinical studies, design of quality systems, submission pathways, as well as advertising and promotion requirements, and working with FDA. All sessions will be conducted by some of the most respected experts in the field.
This workshop will provide critical knowledge for anyone new to the medical device industry, planning a career in medical devices or looking for a way to refresh and enchance their regulatory knowledge.

Featured Speakers from DuVal & Associates:

Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering, DuVal & Associates

Kathy Herzog, BSME
Senior Regulatory, Quality & Compliance Consultant, DuVal & Associates

Aaron Hage, J.D.
Senior Director of Legal-Regulatory & Compliance, DuVal & Associates

Registration & More

Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-day online workshop. Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions.

Featured Speakers from DuVal & Associates:
Mark DuVal, J.D.,FRAPS
President & CEO
DuVal & Associates

Registration & More

The promotion of medical devices is a critical aspect of medical device marketing, and it requires a unique approach to reach target audiences effectively. This event aims to provide attendees with insights into the latest trends, best practices, and strategies for successful medical device advertising. Speakers will discuss topics such as regulatory compliance, messaging, and historical cases. If you want to learn from a true expert in the field, network with industry peers, and gain practical knowledge to help create an effective ad campaign that ensures compliance, this is the event for you. Whether you're a Product Development Engineer, Quality Engineer, Medical Devices Sales Representative, or Product Manager, this event is a must-attend for anyone involved in medical device promotion.

Featured Speakers from DuVal & Associates:

Mark DuVal, J.D.,FRAPS
President & CEO
DuVal & Associates

Registration & More

In this session, we will share insights to help you strategically prepare an eSTAR 510(k) or DeNovo submission. The presentation will cover managing text field content and limitations, organizing and naming attachments, creating advocacy in a modular format, options for creating the 510(k)Summary, and leveraging the Cover Letter and Executive Summary to your advantage. You will learn practical tactics to optimize the quality and facilitate review of your submission. We will also provide an overview of the FDA’s review process for eSTAR submissions and strategies for how to manage submission updates in response to requests for Additional Information.

Featured Speakers from DuVal & Associates:

Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering, DuVal & Associates

Kathy Herzog, BSME
Senior Regulatory, Quality & Compliance Consultant, DuVal & Associates

Registration & More

The Medical Device Manufacturers Association (MDMA)’s FDA Forum will be in Palo Alto, CA March 15-16, 2023. The 2023 FDA Forum will feature senior officials from FDA and industry and focus on the key regulatory issues impacting the medical device industry. Designed specifically for medical device regulatory professionals and executive decision makers, MDMA’s FDA Forum promises to deliver key regulatory insights and preview trends that will impact your regulatory and business strategies.

Featured Speakers from DuVal & Associates:

Mark DuVal, J.D.,FRAPS
President & CEO
DuVal & Associates

Registration & More

Join DuVal & Associates in Munich, Germany for a 2-Day 510(k) Workshop February 23rd-24th, 2023. We help you learn strategies for conquering the increasingly complex FDA 510(k) program. In the popular television series Survivor, individuals are placed on an island isolated from reality with odds stacked against them, trying to fight for their survival while the rulers of the island are constantly changing the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance to be a survivor. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor and conquering the 510(k) program.

Featured Speakers from DuVal & Associates:

Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering
Bryan Feldhaus, J.D., LL.M.
Vice President of Legal-Regulatory and Compliance

Registration & More

Join Aaron Hage and Bryan Feldhaus from DuVal & Associates for this Digital Health Webinar. The Health Law and Food Drug and Device Law sections are co-sponsoring an update to the digital health CLE presented in May 2022. This session will address new material including updates from FDA since the last digital health CLE. Topics will include an overview of how medical device companies, patients, providers and health care organizations engage in digital health, an update on cybersecurity matters relating to digital health, final FDA guidance re clinical decision support and final FDA guidance on software functions. Aaron Hage, Bryan Feldhaus and Aaron Rodriguez will discuss the perspectives from corporate practitioners, law firm counsel and the FDA.

Featured Speakers from DuVal & Associates:

Aaron Hage, J.D.
Senior Director of Legal-Regulatory & Compliance
Bryan Feldhaus, J.D., LL.M.
Vice President of Legal-Regulatory and Compliance

Registration & More

Join DuVal & Associates and the RAPS Twin Cities Chapter on October 25, 2022, from 5:30 – 8:30 pm (dinner included) as we help you learn strategies for conquering the increasingly complex FDA 510(k) program. In the popular television series Survivor, individuals are placed on an island isolated from reality with odds stacked against them, trying to fight for their survival while the rulers of the island are constantly changing the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island with little chance to be a survivor. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor and conquering the 510(k) program.

Featured Speakers from DuVal & Associates:

Mark DuVal, J.D., FRAPS
President & CEO, DuVal & Associates
Lisa Pritchard, BSEEE
VP of Regulatory, Quality, Clinical and Engineering, DuVal & Associates
Kathy Herzog, BSME
Senior Regulatory, Quality & Compliance Consultant, DuVal & Associates

Registration & More

RAPS Convergence 2022 is back and in person! Reunite with regulatory professionals, notified bodies, and global partners 11 – 13 September 2022 in Phoenix, Arizona.

Lisa Pritchard and Kathy Herzog form DuVal & Associates are presenting - Traveling to De Novo Land: Planning for a Successful Journey

The speed of medical device innovation has resulted in increased popularity of the De Novo pathway for US commercialization. This year began with implementation of new regulations for this pathway. This session will cover the statutory evolution of this program, current requirements, expectations for the submission and review process, and tips to help your De Novo journey take off and comfortably land with a successful product commercialization. Key questions that will be answered include: What is a De Novo? When should I consider a De Novo? What are the timelines and cost for a De Novo? How do I prepare a De Novo? What should I expect with the review process? and What are the business implications of a De Novo?e a part of this dynamic and exciting moment as the community focuses on connecting, educating, and inspiring regulatory professionals.

Featured Speakers from DuVal & Associates:
Lisa Pritchard
BSEEE, DuVal & Associates
Kathy Herzog
BSME, DuVal & Associates

Registration & More

Mark DuVal is conducting a 1-day preconference workshop - U.S. Regulatory Essentials - Medical Devices and IVDs.

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line or industry or preparing for the RAC (US) examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; advertising, labeling and promotional aspects; and post-market, compliance and enforcement requirements will be covered.

Featured Speakers:
Mark DuVal, J.D.,FRAPS
President & CEO
DuVal & Associates

Registration & More

In the popular television series Survivor, individuals are placed on an island isolated from reality with odds stacked against them, fighting for their survival while the rulers of the island constantly change the rules, making it difficult to survive. Without knowing how to navigate the 510(k) program, and what alliances are critical for survival, a medical device company is likely to be an early exit from the FDA island. Gaining an understanding of the program and its evolving expectations is like being equipped with the clothes, shelter, tools, and food essential to becoming the survivor. Unlike Survivor – there is plenty of room for more than one winner.

Featured Speaker:
Mark DuVal
President & CEO, DuVal & Associates
Lisa Pritchard
BSEEE, DuVal & Associates
Allison Komiyama
Regulatory Consultant

Registration & More

This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs. It will cover laws, regulations, FDA guidance, strategies for FDA submissions, advertising and labeling, post-market compliance, and more.

Featured Speaker:
Mark DuVal
President, DuVal & Associates

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Mark DuVal of DuVal & Associates, P.A. will provide an update on what is happening at FDA and what developments we are seeing within the Agency on a variety of topics such as the Pre-Submission program, the Breakthrough Device program, and the 510(k) program including FDA’s reshaping of it—through definitional interpretations, performance data requirements, late-stage AINE letters, the push for conversion to de novo submissions, as well as veiled proposals by Dr. Shuren to provide statutory changes. We will leave time to take your questions on these topics and more. 

Featured Speakers:
Mark DuVal
President, DuVal & Associates
Lisa Pritchard
BSEE, DuVal & Associates
Bryan Feldhaus
J.D., LL.M. DuVal & Associates

Heads turn and crowds make way for VIPs as they make their way down the red carpet. What if your medical device could receive this same treatment? The FDA Breakthrough Device Designation program is a way to roll out the red carpet for a device to follow to achieve commercialization. This discussion will provide insights to help you understand the FDA Breakthrough Device Designation program and determine whether this designation should be considered as part of your device development program. DuVal & Associates will share experiences and best practices to help you successfully navigate the Breakthrough Device Designation process to accelerate commercialization of your product that is worthy of VIP status.

In this program, we will cover the following topics:

Featured Speakers:
Lisa Pritchard
BSEE, DuVal & Associates

Gain a thorough understanding of regulatory affairs for medical devices and IVDs in the U.S. in this intensive, two-day online workshop. Regulatory experts will discuss the laws, regulations, and enforcement and agency structures regulating devices and IVD products. They will review advertising, labeling and promotion post-market, as well as compliance and enforcement requirements. The speakers will also cover FDA guidance, and options and strategies for FDA submissions..

Featured Speakers:
Mark DuVal
President, DuVal & Associates
Aaron Hage
Associate Attorney, DuVal & Associates

This webcast will cover the contours of the law, regulations, guidance, and court cases shaping how the U.S. Food and Drug Administration (FDA) views the current state of the law on promoting devices and drugs under the Food, Drug & Cosmetic Act. There will be a special focus on promoting 510(k) devices under FDA's General/Specific Use and 510(k) guidance documents, mostly related to determining what is on and off-label.

Featured Speakers:
Mark DuVal
President, DuVal & Associates
Aaron Hage
Associate Attorney, DuVal & Associates

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In this webinar, based upon our three-part Client Alert series entitled “Navigating the Interesting and Sometimes Strange Pre-Sub Experience,” we will explore the strange world of FDA Pre-submission meetings through the metaphor of the Addams Family—the popular 1960’s TV comedy. We will first present the basics of the Pre-Sub and then use a panel discussion of our in-house experts to provide strategic and tactical—and always practical— insights on the purpose for Pre-Sub, how Pre-Subs come up, whether to request a Pre-Sub or not, how to submit a request for a Pre-Sub, how to prepare for it, and how to document it in meeting minutes, among other topics.

While they may be creepy and kooky, mysterious and spooky, and all together ooky, they are our FDA family. And though their house is a museum when people come to see 'em, they really are a scre-am, they are our FDA Family. Don’t forget to snap your fingers….

Featured Speakers:

This webinar will focus on the FDA program devoted to the most complex, high risk medical devices—the Premarket Approval or PMA process. Lisa Pritchard of DuVal & Associates will share the background of the PMA program, what really is involved, and help to understand the business implications of taking a product through the PMA process. She has over 30 years of experience in the medical device industry, and has worked on PMA products throughout her career at American Medical Systems, Medtronic, Uromedica, EnteroMedics, and DuVal & Associates.

She will answer the following questions and engage in audience Q&A:

• What is a PMA?
• When should I consider a PMA?
• How do I prepare a PMA?
• What should I expect with the review process?
• What are the business implications

Featured Speakers:
Lisa Pritchard
Vice President of Regulatory, Quality, Clinical and Engineering, DuVal & Associates

Kathy Herzog & Mark DuVal of DuVal & Associates will share practical advice on when a De Novo is appropriate and how to prepare a De Novo request. She has over 35 years of experience in the medical device industry working for small and large companies, including American Medical Systems and Medtronic. She will describe the De Novo regulatory pathway as an alternative to automatic Class III designation for novel devices that are low to moderate risk and for which there is no legally marketed predicate device. Devices that are classified into class I or class II through a De Novo request establish a new device type, regulation, and controls. De Novo granted devices may be marketed and become predicates for future 510(k) submissions. She will discuss the following topics and engage in audience Q&A:

• Understanding the two pathways that lead to De Novo: 510(k) NSE or Direct
• De Novo application content elements and level of evidence needed
• The importance of risk assessment to success of a De Novo application
• Strategies on developing special controls
• The role of Pre-Subs for future De Novo requests
• What to expect with FDA’s review process

Featured Speakers:
Kathy Herzog
Regulatory Consultant

This webinar will focus on the FDA program devoted to most medical devices approved by FDA—the 510(k) clearance process. Mark DuVal of DuVal & Associates will share his firm’s vast experience with putting together 510(k)s, infusing war stories illustrating how to overcome FDA objections. He will share how to tell your device’s story and obtain clearance. He has over 33 years of experience working with FDA as former general counsel to 3M Pharmaceuticals and Drug Delivery Systems as well as three medical device divisions, and as head FDA and compliance counsel within Medtronic, followed by over 18 years with DuVal & Associates, P.A. He will discuss the following topics and engage in audience Q&A:

• Understanding the 510(k) is an Advocacy Document, With Evidence
• Choosing the Proper Predicate
• Choosing the Intended Use
• Addressing Sameness in Technological Characteristics
• Addressing Whether You Raise Different Questions of S&E
• FDA Data Requests in a 510(k)

Featured Speakers:
Kathy Herzog
Regulatory Consultant

Join DuVal & Associates President and CEO Mark DuVal at the RAPS Regulatory Convergence 2018 conference in Vancouver, British Columbia.

Mark will be speaking as part of a panel of experts during a workshop entitled "US Regulatory Essentials, Medical Devices and IVDs" on October 1st, 2018.

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