Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

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

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

  1. Overview
  2. Agendas
  3. Location

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 5-6, 2024
IDE Submissions Workshop: February 7, 2024
PMA Submissions Workshop: February 8-9, 2024

Register now

Join us in February for our three back-to-back, Medical Device Submissions Workshops, including: 510(k) and De Novo; Investigational Device Exemption (IDE); Premarket Approval (PMA)! After years of hosting this event virtually, we’re excited to offer a hybrid experience that includes a virtual and in-person option in our Washington, D.C. office! The hybrid format allows us to offer a more comprehensive and interactive experience, while providing the same access to real-world case studies, tips and best practices directly from the FDA and leading industry experts. These workshops are instrumental in guiding professionals through the intricate world of medical device submissions, so if you’re new to medical device regulatory affairs, or looking to strengthen your foundational knowledge, this is the perfect program for you. Sign-up below to be the first to receive more information on these can’t-miss workshops!

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

The 2024 agenda will be announced soon, so join our mailing list to be the first to know when it’s out. In the meantime, view the 2023 agenda below to see what you can expect from this year’s program.

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 
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) 
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 

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  

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   
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 
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

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 

After hosting this event virtually for the past few years we’re excited to include a hybrid option for the 2024 Workshops. Attendees can register to join us in our AdvaMed offices located at 1301 Pennsylvania Ave NW Suite #400, Washington, D.C. 20004.

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