Glad it was helpful! It was an idea that resulted from a client that didn't know what "510(k) exempt" meant. The best topics are always from customer and potential customers. Rob
This video was recorded on March 3, 2023. The next video was on March 10, 2023: ruclips.net/user/liveLc3NIeav-bM. You can search our channel for video topics as well.
I have invented a workout machine which is improved from other devices on the market. Basically a modified flywheel used in eccentric exercise equipment. How do I go about establishing which class it would fit in or if I would have to apply as a de novo device. Any insight would be appreciated. Thank you, Alfredo
Class 1 device are exempt from design controls (i.e., 21 CFR 820.30), unless the device is one of the 5 device types listed in 21 CFR 820.30(a)(2)(ii) listed below or automated with computer software: 1.Catheter, Tracheobronchial Suction 2. Glove, Surgeon's 3. Restraint, Protective 4. System, Applicator, Radionuclide, Manual 5. Source, Radionuclide Teletherapy You also indicated that the device is not GMP exempt. Therefore, all other sections of 21 CFR 820 will apply. There are some typical exceptions (e.g., installation and service do not apply to all devices).
Thank you for this video, very well explained
Glad it was helpful! It was an idea that resulted from a client that didn't know what "510(k) exempt" meant. The best topics are always from customer and potential customers.
Rob
great video! thank you. Sorry, where can i find the "next video" about regulatory pathway analysis mentioned?
This video was recorded on March 3, 2023. The next video was on March 10, 2023: ruclips.net/user/liveLc3NIeav-bM. You can search our channel for video topics as well.
Awesome presentation!!
Glad you liked it!
I have invented a workout machine which is improved from other devices on the market. Basically a modified flywheel used in eccentric exercise equipment. How do I go about establishing which class it would fit in or if I would have to apply as a de novo device. Any insight would be appreciated.
Thank you, Alfredo
for class 1 exempt but not GMP exempt, do I need to be in compliance with full 820 or procedures just per the associated risk of the device?
Class 1 device are exempt from design controls (i.e., 21 CFR 820.30), unless the device is one of the 5 device types listed in 21 CFR 820.30(a)(2)(ii) listed below or automated with computer software:
1.Catheter, Tracheobronchial Suction
2. Glove, Surgeon's
3. Restraint, Protective
4. System, Applicator, Radionuclide, Manual
5. Source, Radionuclide Teletherapy
You also indicated that the device is not GMP exempt. Therefore, all other sections of 21 CFR 820 will apply. There are some typical exceptions (e.g., installation and service do not apply to all devices).
Nice and clear
Glad you think so!