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/.

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Next 510(k) workshop is April 18 in Chicago: http://medicaldeviceacademy.com/chicago-510k-workshop/.

source: https://www.linkedin.com/groups/2070960/2070960-6250169571886661632