There have been a number of changes to the special 510k process since this presentation. The "No intended use change" restriction was removed in 2019. Here is the new guidance www.fda.gov/media/116418/download
Love your explanations! Could you please udpate us the link to FDA's 500examples(video min:42:45) I was not able to access to it. Many thanks for your labor
I just tried the database. All of the FOIA links appear to have disappeared since last week. I know I saw links on the database last week, but they are not available right now. Once the FDA fixes this, I will post a follow-up and record a video.
The predicate device is a competitor product that already has 510(k) clearance or a pre-amendment device. The answer for your device depends on many variables about the specifics of your device. The predicate device would be a device that is already approved and on the market that has 510(k) clearance or is a pre-amendment device that you are able to prove is 'substantially equivalent' in safety and efficacy to your device. That paints the picture with a very broad brush because things such as intended use, device risks, intended users all need to be looked at individually as well as some highly specialized areas such as biocompatibility and maybe software that are going to unique to each type of device. This is only if there is a predicate device to select, if your device is so new that there is nothing substantially equivalent then there are other paths that can be taken for premarket notifications. If you need a consultation for help with building a regulatory pathway for your device please feel free to reach out by email or schedule a free meeting with Calendly. The link below is for the contact area of our website. medicaldeviceacademy.com/contact-us-3/
For a truly novel device, there is no predicate, and 510(k) clearance is not possible. Instead, your device will require a De Novo Request for a new classification. This is very common for IVD products that are detecting new analytes, but it also happens if your device has a different indication for use. For example, the first TENS device used to treat migraines needed De Novo approval. All subsequent submissions were 510(k) submissions.
this presentation hits the spot. many many thanks.
You're very welcome.
There have been a number of changes to the special 510k process since this presentation.
The "No intended use change" restriction was removed in 2019.
Here is the new guidance www.fda.gov/media/116418/download
Love your explanations!
Could you please udpate us the link to FDA's 500examples(video min:42:45)
I was not able to access to it.
Many thanks for your labor
I just tried the database. All of the FOIA links appear to have disappeared since last week. I know I saw links on the database last week, but they are not available right now. Once the FDA fixes this, I will post a follow-up and record a video.
Rob you are great. Please let me know 510 traditional - original - will have new device. in this case what will be predicated device ?
The predicate device is a competitor product that already has 510(k) clearance or a pre-amendment device.
The answer for your device depends on many variables about the specifics of your device. The predicate device would be a device that is already approved and on the market that has 510(k) clearance or is a pre-amendment device that you are able to prove is 'substantially equivalent' in safety and efficacy to your device.
That paints the picture with a very broad brush because things such as intended use, device risks, intended users all need to be looked at individually as well as some highly specialized areas such as biocompatibility and maybe software that are going to unique to each type of device. This is only if there is a predicate device to select, if your device is so new that there is nothing substantially equivalent then there are other paths that can be taken for premarket notifications.
If you need a consultation for help with building a regulatory pathway for your device please feel free to reach out by email or schedule a free meeting with Calendly. The link below is for the contact area of our website.
medicaldeviceacademy.com/contact-us-3/
For a truly novel device, there is no predicate, and 510(k) clearance is not possible. Instead, your device will require a De Novo Request for a new classification. This is very common for IVD products that are detecting new analytes, but it also happens if your device has a different indication for use. For example, the first TENS device used to treat migraines needed De Novo approval. All subsequent submissions were 510(k) submissions.