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
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
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
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 am | Welcome and Introductions |
| 11:05 am – 12:00 pm | Beginning 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 pm | Group Q&A |
| 1:00 pm – 1:15 pm | Break |
| 1:15 pm – 1:55 pm | Mechanics 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 pm | Group Q&A |
| 2:55 pm – 3:10 pm | Break |
| 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 D. Banik, Policy Analyst, FDA
Angela D. DeMarco, Biomedical Engineer, 510(k) Program Expert, FDA
Jacob Dyer, FDA
Irfan Khan, Clinical Evidence Quality Team Lead, FDA
Stacy Monza, FDA
Christina L. Savisaar, Policy Analyst, FDA
Ken Skodacek, CDRH Deputy Ombudsman, FDA
Peter J. Yang, De Novo Program Lead, FDA
Industry Speakers
Tony L. Blank, Senior Director, Regulatory Affairs, AtriCure, Inc.
Jennifer A. Bolton, Senior Regulatory Fellow, Boston Scientific Corporation
Holly C. Drake, Director, Regulatory Affairs, Dexcom, Inc.
Quynh T. Hoang, Senior Regulatory Consultant, King & Spalding LLP
Sally L. Maher, Consultant, Sally Maher Consulting
Angela Mallery, NAMSA
Monica R. Montanez, NAMSA
Neeta Sharma, Dexcom
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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