Bear with me here.
The news release said: "PressureSafe™ is classified as a Class I device and is exempt from 510(k) premarket submission."
This page says: Device Class and Regulatory Controls
1. Class I General Controls
With Exemptions
Without Exemptions
2. Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3. Class III General Controls and Premarket Approval
The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
Link: https://www.fda.gov/medical-devices/overview-...cal-device
Finally this page says: : A company that has registered with the FDA and has listed their device and the activities performed on those devices at that establishment, into the FDA's registration and listing database. It applies to all class devices, but for most of the Class I devices, it is the only form of registration with FDA. Important to know: the FDA does not issue any type of device registration certificates to medical device facilities.
Cleared/Clearance: Most of the Class II and some Class I devices require a Pre-Market Notification (510(k)) submission. Before you can sell a device to the public, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be sold in the U.S. This order clears the device for commercial distribution.
Link: https://www.rimsys.io/blog/fda-listed-cleared...ed-granted
So if we are exempt, this should be a very quick approval?
The news release said: "PressureSafe™ is classified as a Class I device and is exempt from 510(k) premarket submission."
This page says: Device Class and Regulatory Controls
1. Class I General Controls
With Exemptions
Without Exemptions
2. Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3. Class III General Controls and Premarket Approval
The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
Link: https://www.fda.gov/medical-devices/overview-...cal-device
Finally this page says: : A company that has registered with the FDA and has listed their device and the activities performed on those devices at that establishment, into the FDA's registration and listing database. It applies to all class devices, but for most of the Class I devices, it is the only form of registration with FDA. Important to know: the FDA does not issue any type of device registration certificates to medical device facilities.
Cleared/Clearance: Most of the Class II and some Class I devices require a Pre-Market Notification (510(k)) submission. Before you can sell a device to the public, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be sold in the U.S. This order clears the device for commercial distribution.
Link: https://www.rimsys.io/blog/fda-listed-cleared...ed-granted
So if we are exempt, this should be a very quick approval?
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