Advanced Seminar "510(k) Premarket Notification"

The seminar covers the following topics: 

• Basics: What is a 510(k) 
• Selecting a suitable predicate device 
• Determining points for the substantial equivalence discussion 
• Working with eSTAR and administrative tasks 
• Determining the correct 510(k) type 
• Identifying applicable and important FDA guidance documents and recognized standards 
• Submitting pre-subs 
• Determining documents to be submitted for the 510(k) submission 
• Documentation requirements with a focus on: 
  • Software 
  • Usability 
  • Bench testing 
• Evaluating changes after submission

After the seminar, you will be able to: 

• fill out eSTAR correctly. 
• identify and justify a predicate device. 
• write an SE discussion. 
• distinguish between 510(k) types and select the correct one. 
• write and review required documents for the 510(k). 
• understand the FDA submission and review process. 
• submit a 510(k) via the CDRH portal.

This seminar is designed for: 

• Regulatory affairs employees 
• Employees responsible for preparing and submitting (parts of) a 510(k) submission

Basic knowledge of the FDA's general requirements is recommended, e.g., through our "FDA Compact Seminar," but is not mandatory. 

Basic English skills are required to read and understand English texts. 

To edit the FDA's eSTAR template, you will need a PDF editing program, such as Adobe Professional or PDF-XChange Editor. 

Participants who have a specific device in mind for which the 510(k) submission is to be submitted will benefit most. Alternatively, a sample device provided can be used. 

Important: If you wish to submit an IVD medical device, please send us a brief note when registering for the seminar so we can prepare the correct templates.

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.