Ship & Print Your FDA eCopy
2 min reading time
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% less documentation for the design of a Class 1 device.
Despite the lack of design controls for Class 1 devices, manufacturers must still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs) and design changes may still require revalidation prior to implementation.
Class 1 devices are simple devices that are already on the market and have a history of clinical safety. Class 2 devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a greater risk for Class 2 devices. When you design a Class 1 device, you still have to determine what your design specifications will be, but you don’t need: 1) to review and approve design inputs, 2) a procedure to document your design process, 3) to document formal design reviews, and 4) to create a design plan.
In the 1997 guidance document for design controls, the FDA states that a design transfer procedure should include at least three basic elements. The first of these basic elements (i.e., design and development procedures) is not required for Class 1 devices, because product specifications for most Class 1 devices are simple. The other two requirements are basic principles of document control and configuration management. Therefore, you still need a design transfer procedure for Class 1 devices but you don’t need to include the first element that relies upon design and development procedures.
If you have a Class 1 device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you must still validate and re-validate the process in accordance with 21 CFR 820.75. Class 1 products also require, a device master record (DMR) in accordance with 21 CFR 820.181.
Although you do not technically have to have a DHF for a Class 1 products, the difference between the two categories is the following elements: 1) Design Control Procedure, 2) Design Plan, 3) Approved Design Inputs, and 4) Evidence of at least 1 Design Review.
If you are interested in learning more about design history files (DHF), please read this week’s blog: http://www.medicaldeviceacademy.com/blog/.
Next 510(k) workshop is April 18 in Chicago: http://medicaldeviceacademy.com/chicago-510k-workshop/.
Marked as spam
Meet your next client here. Join our medical devices group community.
Matthew Martin My experience is having to have a full DHF and RMF for class I products. Not tongue depressors but medical treadmills, partial body weight devices, Balance devices, Ultrasound Imaging Tables and Imaging Surgical tables. Where are you coming from on this?
Marked as spam
Erik Hatlanek I think that class I devices in EU are under responsability of the manufacturer. So a ISO 13485:2003 certification is still necessary to assure the technical file of the device and the procedure shoud be verified be the auditor in certification ISO 13485:2003. By the introduction of MDR this year and in case of ISO 13485:2016 certification observe item of the standard 4.2.3 Medical device file. 4.2.4 Contrôle of documents and 4.2.5 Control of records. In item 4.1.3 e) mentionne "compliance with applicable regulatory requirements" (see MDR).
Marked as spam
Please log in to post questions.