Events

2023 Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: May 15-17, 2023
IDE Submissions Workshop: May 18-19, 2023
PMA Submissions Workshop: May 23-25, 2023

Register now

Gain access to FDA and industry experts who will guide you through the critical medical device submissions process step-by-step during these virtual workshops!

2023 Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: May 15-17, 2023
IDE Submissions Workshop: May 18-19, 2023
PMA Submissions Workshop: May 23-25, 2023

Register now

  1. Overview
  2. Agendas
  3. Speakers
  4. Pricing

2023 Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: May 15-17, 2023
IDE Submissions Workshop: May 18-19, 2023
PMA Submissions Workshop: May 23-25, 2023

Register now

Join us in May for our online Medical Device Submissions Workshops, including: 510(k) and De Novo, Investigational Device Exemption (IDE), and Premarket Approval (PMA) Submissions. These workshops are the ideal introductory program for professionals who are new to medical device regulatory affairs looking for an unparalleled opportunity to learn more about regulatory requirements for bringing products to market.

This is the only set of Submissions Workshops we will have in 2023, so don’t miss out on this unique experience to access FDA and industry experts while enjoying our interactive workshops from the comfort of your home or office!

Who should attend?

  • Medical device professionals new to the FDA regulatory submission process
  • Regulatory Affairs Professionals
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Regulatory Affairs Rotational Associates

510(k) and De Novo Submissions Workshop

*Schedule reflects Eastern Time 

May 15, 2023

 11:00 am – 11:05 am  Welcome and Introductions  
11:05 am – 11:50 am  The Law and Regulations   
Sally Maher, Sally Maher Consulting

510(k) definition 
510 and 513 FDCA 
Guidance for 510(k): general & product specific 
– How to find it 
– How to use it
Different types of 510(k)s; which to use
Review of bundling 510(k)s 
FDA Product Codes – activity   
11:50 am – 12:35 pm  510(k) Strategy and Planning  
Tony Blank, AtriCure  

Staff involved
Role of each function 
RA responsibilities 
Use of guidance 
Global considerations 
Pre-submissions 
Predicates 
Breakthrough Devices Program 
Safer Technologies Program   
12:35 pm – 12:50 pm  Group Q&A    
12:50 pm – 1:05 pm  Break   
1:05 pm – 2:20 pm     Preparing the Submission  
Dave McGurl, MCRA 
Michael Nilo, Nilo Medical Consulting

General information including how to select a predicate device  
Assembling the 510(k) 
ECopy   
2:20 pm – 2:35 pm  Break    
 2:35 pm – 3:50 pm The FDA Review Process  
Angela DeMarco, FDA  

How it works at FDA  
FDA/industry interactions 
Refuse to Accept 
Submission Issue meetings 
FDA holds 
Interactive review
Least Burdensome flag 
Current pilots   
3:50 pm – 4:20 pm  CDRH Ombudsman’s Office   
Ken Skodacek, FDA  

Roles & Responsibilities 
Appeals Process   
4:20 pm – 4:35 pm  Group Q&A   

May 16, 2023

11:00 am – 11:05 am Welcome    
11:05 am – 12:20 pm  Clearance: Launch and After    
Tony Blank, AtriCure  

What clearance does and does not mean 
Promotional practices for 510(k) devices 
– FDA 
– FTC 
Complaint Handling and MDRs 
When to File a New 510(k) for Device Modifications 
Catch-up 510(k)s   
12:20 pm – 12:30 pm  Group Q&A   
12:30 pm – 12:45 pm  Break   
12:45 pm – 1:15 pm  De Novo  
Quynh Hoang, King & Spalding  

Definition of a De Novo 
Final Rule on De Novo 
When De Novo is used 
Differentiation from 510(k)    
1:15 pm – 1:45 pm     Regulatory Strategy for De Novo
Holly Drake, Dexcom 
Neeta Sharma, Dexcom  

 Key eligibility criteria
 Benefit-risk analysis   
1:45 pm – 2:15 pm Preparing the De Novo Submission  
Holly Drake, Dexcom 
Neeta Sharma, Dexcom 

Content 
Assembling the submission   
2:15 pm – 2:30 pm  Group Q&A   
2:30 pm – 2:45 pm Break   
2:45 pm – 3:15 pm  FDA Review Process for De Novo 
Peter Yang, FDA  

Use of Pre-Submission meeting 
Rationale for De Novo 
Clinical Protocols 
Special Controls   
3:15 pm – 3:45 pm  Maintenance of a Granted De Novo  
Peter Yang, FDA  

Post-market requirements 
Classification Order 
De Novo database, granting order, decision summary 
Use as a predicate 
Making changes to granted De Novo device    
3:45 pm – 4:00 pm  Group Q&A   
4:00 pm   Closing Remarks and Adjourn   

May 17, 2023 

12:00 pm – 1:15 pm  Applied Learning and Breakout Discussions
Sally Maher, Sally Maher Consulting 
Tony Blank, AtriCure 
Quynh Hoang, King & Spalding 
 
510(k) & De Novo Recap 
Facilitated Breakout Group
– Deep Dive 
– Hypothetical Case Studies  
Key Takeaways  
Regroup for Final Program Q&A 

Investigational Device Exemption (IDE)
Submissions Workshop

*Schedule reflects Eastern Time 

May 18, 2023

11:00 am – 11:05 am   Welcome and Introductions   
11:05 am – 11:40 am  What Is an IDE? 
Christina Savisaar, FDA  

Regulatory Context 
When is an IDE needed? 
Roles of sponsors, investigators and IRBs 
The IDE Application and Helpful Tips   
11:40 am – 12:15 pm    Developing an IDE Strategy 
Tony Blank, AtriCure 

What to consider and when 
Preclinical testing before human studies 
Making the best use of pre-submission meetings 
Using foreign data in a US submission 
Characteristics of a successful IDE submission   
12:15 pm – 12:20 pm Break   
12:20 pm – 1:25 pm  Preparing the Technical & Functional Aspects of an IDE
Kristin Zielinski Duggan, Hogan Lovells 

Elements of an IDE: Intro/Background, Manufacturing/Device, Labeling, Reference/Other 
Avoiding common errors and deficiencies 
The role of risk analysis in an IDE 
Managing planned or unplanned device or study changes   
1:25 pm – 1:40 pm  Group Q&A   
1:40 pm – 1:55 pm  Break   
1:55 pm – 2:30 pm Regulatory Compliance During Study Conduct  

Monitoring 
Consenting of patients 
Enrollment requirements 
Adverse event reporting 
Sponsor records and reports 
Investigator records and reports 
Protocol deviations   
2:30 pm – 3:05 pm  Reporting Results   
Kristin Zielinski Duggan, Hogan Lovells 

Clinical study reports (interim and final) 
Dissemination to the medical community and to regulators 
Incorporation into pre-market submissions 
Assessment of impact to product labeling 
Requirements for registering trials on CT.gov   
3:05 pm – 3:40 pm  Optimizing the Pre-Submission Meeting 
Tony Blank, AtriCure  

Purpose and value of the meeting 
Requesting a Pre-sub meeting 
Identifying discussion questions 
Team preparation and rehearsals   
3:40 pm – 3:55 pm  Group Q&A    
3:55 pm – 4:10 pm Break   
4:10 pm – 4:40 pm  BIMO Inspections  
Irfan Khan, FDA  

The purpose of a BIMO inspection 
When and how a BIMO inspection occurs 
Preventing findings and responding to findings 
Typical and atypical observations – cautionary tales from the field   
4:40 pm Closing Remarks and Adjourn   

May 19, 2023 

12:00 pm – 1:15 pm Applied Learning and Breakout Discussions
Kristin Zielinski Duggan, Hogan Lovells 
Tony Blank, AtriCure 

IDE Recap
Facilitated Breakout Group
– Deep Dive 
– Hypothetical Case Studies  
Key Takeaways  
Regroup for Final Program Q&A 

Premarket Approval (PMA) Submissions Workshop 

*Schedule reflects Eastern Time 

May 23, 2023 

11:00 am – 11:05 amWelcome and Introductions   
11:05 am – 12:00 pmBeginning at the Beginning  
Quynh Hoang, King & Spalding  

When is a De Novo or PMA required PMA:  what to expect
What are the standards of evidence
What are the standards of review 
Will submission go to panel 
How much will it cost 
How long will it take to get approval  
12:00 pm – 12:45 pm Development of a PMA Submission Strategy
Stacy Monza, FDA   

Product definition 
Development of testing requirements and strategy 
Desired patient population 
Desired claims 
Early interactions with FDA 
Planning for product iterations  
12:45 pm – 1:00 pmGroup Q&A  
1:00 pm – 1:15 pmBreak   
1:15 pm – 1:55 pmMechanics of PMA Quality System Submission Development and Review  
Jhumur Banik, FDA  

Defining data requirements  
Required elements 
Presentation of information with clarity 
Expectations during review 
Best practices 
Manufacturing & Quality Systems 
Case for Quality 
1:55 pm – 2:40 During Submission Review  
Jennifer Bolton, Boston Scientific

Interactions with the FDA 
When/How to expect questions 
Types of letters 
Timelines 
Day 100 meetings 
Labeling review   
2:40 pm – 2:55 pmGroup Q&A    
2:55 pm – 3:10 pmBreak   
3:10 pm – 3:55 pm         Conditions of Approval Studies
Jennifer Bolton, Boston Scientific

Criteria and objectives 
Early collaboration with FDA 
Reaching agreement 
Reporting outcomes 
522 Studies  
3:55 pm – 4:40 pm Preparation for Advisory Panels  
Jessica Ringel, King & Spalding

When? 
Who are the panel members? 
Why have a panel meeting? 
Preparation for a panel meeting 
What to expect before, during, and after 
Best practices   
4:40 pm – 4:55 pm   Group Q&A   
Close Day 1 of Program  

May 24, 2023

11:00 am – 11:45 am Inspection Activity  
Jacob Dyer, FDA

Pre-approval inspections 
How to prepare for an inspection  
11:45 am – 12:45 pm Dealing with the Unexpected  
Tony Blank, AtriCure  

Clinical outcomes 
Animal test results 
Adverse panel recommendation   
12:45 pm – 1:00 pm  Group Q&A   
1:00 pm – 1:15 pm  Break   
1:15 pm – 2:00 pm The Care and Feeding of Approved PMAs  
Monica Montanez, NAMSA

Periodic (“Annual”) Reports 
Supplemental Submissions  
30-day notices   
2:00 pm – 2:30 pm  CDRH Ombudsman’s Office   
Ken Skodacek, FDA  

Roles & Responsibilities 
The Appeals Process   
2:30 pm– 2:45 pm  Group Q&A   
2:45 pm  Closing Remarks and Adjourn    

May 25, 2023 

12:00 pm – 1:15 pm Applied Learning and Breakout Discussions
Jennifer Bolton, Boston Scientific 
Quynh Hoang, King & Spalding 
Angela Mallery, NAMSA

PMA Recap 
Facilitated Breakout Group Deep Dive 
– Hypothetical Case Studies  
– Key Takeaways  
Regroup for Final Program Q&A 

View the FDA and industry speakers that will guide you through the device submissions process.

FDA Speakers

Jhumur Banik Headshot

Jhumur D. Banik, Policy Analyst, FDA

Angela DeMarco Headshot

Angela D. DeMarco, Biomedical Engineer, 510(k) Program Expert, FDA

Jacob Dyer, FDA

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Irfan Khan, Clinical Evidence Quality Team Lead, FDA

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Stacy Monza, FDA

Christina Savisaar Headshot

Christina L. Savisaar, Policy Analyst, FDA

Ken Skodacek Headshot

Ken Skodacek, CDRH Deputy Ombudsman, FDA

Peter Yang Headshot

Peter J. Yang, De Novo Program Lead, FDA

Industry Speakers

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Tony L. Blank, Senior Director, Regulatory Affairs, AtriCure, Inc.

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Jennifer A. Bolton, Senior Regulatory Fellow, Boston Scientific Corporation

Holly Drake Headshot

Holly C. Drake, Director, Regulatory Affairs, Dexcom, Inc.

Quynh T. Hoang Headshot

Quynh T. Hoang, Senior Regulatory Consultant, King & Spalding LLP

Sally Maher Headshot

Sally L. Maher, Consultant, Sally Maher Consulting

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Angela Mallery, NAMSA

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Monica R. Montanez, NAMSA

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Neeta Sharma, Dexcom

Kristin Zielinski Duggan Headshot

Kristin Z. Zielinski Duggan, Partner, Hogan Lovells US LLP

Registration Pricing

Click here to check if your company is an AdvaMed member.

510(k) and De Novo Submissions Workshop
  • AdvaMed Member Companies: $1350.00
  • AdvaMed Accel Member Companies: $630.00
  • Government /Nonprofit: $630.00
  • Non-Members: $1830.00
IDE Submissions Workshop
  • AdvaMed Member Companies: $675.00
  • AdvaMed Accel Member Companies: $510.00
  • Government /Nonprofit: $510.00
  • Non-Members: $975.00
PMA Submissions Workshop
  • AdvaMed Member Companies: $1350.00
  • AdvaMed Accel Member Companies: $630.00
  • Government /Nonprofit: $630.00
  • Non-Members: $1830.00

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