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
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
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
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 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 |
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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