What is a Class 1 and 2 device exemption?
Ғылым және технология
Next week I will be publishing a blog on the FDA regulatory pathway for medical devices, but today we are going to talk about what it means when you see the word "exempt." We also talk about the different types of exemptions:
The FDA established a risk-based device classification system for medical devices with Section 513 of the Food, Drug, and Cosmetic Act. Each device is assigned to one of three regulatory classes: Class I, Class II, or Class III. This classification is based on the level of control needed to ensure safety and effectiveness of medical devices.
As a device class increases from Class I, to Class II, and to Class III, the regulatory controls also increase.
All Class III devices require Pre-market Approval or a PMA.
Most Class II devices require a pre-market notification (i.e., 510k clearance).
Most Class I devices are exempt from pre-market notification. www.fda.gov/medical-devices/c...
There is also an exemption from the quality system requirements (i.e., 21 CFR 820), and there is an exemption from design controls.
If you want to learn more about how to conduct a regulatory pathway analysis for a medical device in the USA, including humanitarian device exemptions (HDE), please read our blog on the topic next week: medicaldeviceacademy.com/blog/
Пікірлер: 12
Nice and clear
@MedicalDeviceAcademy
4 ай бұрын
Glad you think so!
Thank you for this video, very well explained
@MedicalDeviceAcademy
Жыл бұрын
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
Technically, Class 3 devices are 510K-exempt because they require a PMA.😊
@MedicalDeviceAcademy
5 ай бұрын
I suppose that is technically correct.
great video! thank you. Sorry, where can i find the "next video" about regulatory pathway analysis mentioned?
@MedicalDeviceAcademy
11 ай бұрын
This video was recorded on March 3, 2023. The next video was on March 10, 2023: kzread.infoLc3NIeav-bM. You can search our channel for video topics as well.
Awesome presentation!!
@MedicalDeviceAcademy
Жыл бұрын
Glad you liked it!
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?
@MedicalDeviceAcademy
3 ай бұрын
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).