- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
I have 12 years experience working in the medical device industry. I deal with regulatory bodies as the FDA and BSI every other month. The company I work for design and create implantable devices which are scrutinised far more than non-implantable devices such as Dr. Susan Shore's.
I can give a brief overview of the process and answer any further questions (if I'm able to that people may have).
Generally, upon submission for regulatory approval with the FDA, a 6 month clock starts. The FDA normally review all the data, studies, reports etc within 2-4 weeks and will send back a list of questions to you. At this point, the 6 month clock pauses. You have 2 weeks to respond to their questions and/or provide the necessary missing data.
When you go back to them, the clock starts again. If they are not satisfied, they may either come back to you or perform an in-person audit. During the audit, they can and do ask to see any data/reports etc they like. This can range from study data to technical drawings of the device. If you cannot provide these, you get a deficiency letter and have 14 days to provide the FDA with a thorough plan of how you intend to fix the issue(s). If the issue is huge, the submission is rejected and you can re-submit once you have carried out the necessary work they have asked for. On the other hand, if they are happy, your submission application may get expedited. But more often than not, the FDA use every minute of that 6 months they allow themselves.
Once you receive approval, you are in a position to immediately begin manufacturing and/or shipping of your device.
Each country has its own regulatory body like the FDA. Generally, the FDA are the worst to deal with (i.e. they ask to see some obscure stuff). If you gain FDA approval, you're almost guaranteed worldwide approval (although Japan are also notoriously difficult).
If you're an American based company, it's a lot easier to get FDA approval, so that should go in our favour with this device.
As this is a non-implantable, non-pharmaceutical, non life-sustaining device, I seriously cannot see any issues with FDA approval. There is no way the submission will take 2 years as per other posts.
I can give a brief overview of the process and answer any further questions (if I'm able to that people may have).
Generally, upon submission for regulatory approval with the FDA, a 6 month clock starts. The FDA normally review all the data, studies, reports etc within 2-4 weeks and will send back a list of questions to you. At this point, the 6 month clock pauses. You have 2 weeks to respond to their questions and/or provide the necessary missing data.
When you go back to them, the clock starts again. If they are not satisfied, they may either come back to you or perform an in-person audit. During the audit, they can and do ask to see any data/reports etc they like. This can range from study data to technical drawings of the device. If you cannot provide these, you get a deficiency letter and have 14 days to provide the FDA with a thorough plan of how you intend to fix the issue(s). If the issue is huge, the submission is rejected and you can re-submit once you have carried out the necessary work they have asked for. On the other hand, if they are happy, your submission application may get expedited. But more often than not, the FDA use every minute of that 6 months they allow themselves.
Once you receive approval, you are in a position to immediately begin manufacturing and/or shipping of your device.
Each country has its own regulatory body like the FDA. Generally, the FDA are the worst to deal with (i.e. they ask to see some obscure stuff). If you gain FDA approval, you're almost guaranteed worldwide approval (although Japan are also notoriously difficult).
If you're an American based company, it's a lot easier to get FDA approval, so that should go in our favour with this device.
As this is a non-implantable, non-pharmaceutical, non life-sustaining device, I seriously cannot see any issues with FDA approval. There is no way the submission will take 2 years as per other posts.