How to Prepare a 510(k) Submission
🎤 Edwin Waldbusser | 📅 February 02, 2023 | 🕒 11 AM Eastern Time US
Description:
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on device software. We will cover the requirements for software. The requirements for preparing a 510(k) for a device modification will be discussed following the newly released guidance.
Areas Covered in the Session:
- Unique terminologies in 510(k)
- What is Refuse To Accept policy
- What is a predicate device
- Selecting a predicate device (substantial equivalence)
- Where to find substantially equivalent predicate devices
- How to handle software
- 510(k) procedure for device modifications
