As I understand the FDA bafflegab what we need is a declaration that the device is SE:
An order declaring a device to be SE (SE letter) is a letter issued to the 510(k) submitter stating that FDA has determined that the device described in the 510(k) submission is substantially equivalent to a legally marketed device.4 An order declaring a device to be SE authorizes marketing of the device in the United States (U.S.), subject to specific statutory and regulatory requirements of FDA.5
An NSE declaration will be a disaster:
An order declaring a device to be NSE (NSE letter) is a letter issued to a 510(k) submitter stating that FDA has determined that the device described in the 510(k) submission is not substantially equivalent to any legally marketed device and may not be introduced into commercial distribution in the U.S.
In general, FDA issues an NSE letter in the following situations:
- no predicate device exists;
- the device has a new intended use compared to the predicate device;
- the device has different technological characteristics that raise different questions of safety and effectiveness than the predicate device; or
- the device has new indications for use or different technological characteristics than the predicate device and required performance data6 was not provided to allow FDA to reach a substantial equivalence determination.
An NSE decision shuts off the review clock, marks the end of FDA review, and is considered a final action.
There is an FDA CLOCK which runs when action is required by the FDA. Day 0 (zero) was when The submittal was made , Jan 28. Mar 29 ( Dr. Cash) will be 60 FDA days. The 60 are for a Substantive Interaction FDA-TOS:
Once the submission has been accepted, FDA should conduct the substantive review and communicate with the submitter through a Substantive Interaction within 60 calendar days of receipt of the 510(k) submission. The Substantive Interaction communication can be an AI request or an email stating that FDA will continue to resolve any outstanding deficiencies via Interactive Review. An SE letter issued prior to the Substantive Interaction goal date will also qualify as a Substantive Interaction for purposes of meeting the MDUFA III goal.
Following a Substantive Interaction, FDA intends to work with the submitter via Interactive Review to reach a MDUFA decision.
An AI request (Additional Information) stops the FDA clock and starts the TOS clock. TOS has 180 days on its clock to reply to FDA satisfaction. Receipt of an acceptable reply will restart the FDA clock which will then have a total of 90 days in which to render a decision SE or NSE. If the reply is not acceptable the TOS clock restarts and the FDA clock stops and goes back to its count as of the date of the AI request.
After the SI an additional 30 days can run on the FDA clock for a decision:
| Action || Review Time (FDA days || |
| || || || || |
| Substantive Interaction || 60 || || || || || |
| MDUFA Decision (SE/NSE) || |
It seems that we could have anywhere between 60 FDA days and 90+180 = 270 total days (FDA+TOS) to wait.
Everyone Happy bout dat ??