Most regulatory experts work on medical device OR in vitro diagnostics–not both. Making the switch from one type of 510(k) to another is not that hard.

First, the submission content and format requirements are the same. There are still 20 sections, and you use the same templates for either type of submission. At least a dozen forms are identical:
1. User fee (FDA Form 3601)
2. Table of contents
3. Cover sheet (FDA Form 3514)
4. Cover letter
5. Confidentiality certification
6. Indications for use (FDA Form 3881)
7. 510(k) summary
8. Truthful and accuracy statement
9. Class III summary
10. Financial certification
11. Declaration of conformity (FDA Form 3654)
12. Executive Summary

The differences between the two types of 510(k) submissions are also very predictable. The most significant difference is related to section 20–clinical performance testing. For a medical device, typically this section is not applicable. Only 10-15% of 510(k) submissions typically include a human clinical study. However, IVD products require clinical studies for 100% of submissions. IVD studies are different, because the study involves specimens–not human subjects. The specimen might be saliva, blood or plasma; but you still need clinical data to demonstrate efficacy of your diagnostic test.

There are specific questions in 510(k) RTA checklists for IVD products as well–regardless of which type of 510(k) submission you are working on. If you are making changes to an existing in IVD product, there are also specific questions in the FDA guidance documents for IVD products to help you determine if a 510(k) submission is required for your device modification.

If you are interested in learning more about IVD 510(k) submissions, there will be a webinar this Friday at 10am EDT: http://medicaldeviceacademy.com/ivd-510k-webinar/.

You can also watch the free webinar on 510(k) submissions in general that was hosted by Joe Hage: https://medicaldevicesgroup.net/webinar/510k-tips/.

source: https://www.linkedin.com/groups/2070960/2070960-6247220661937405953