In this warning letter breakdown, we are going to examine one of the top 10 reasons why medical device firms receive citations.
Reference From Actual Warning Letter
1. Although not appearing on the Form FDA 483, failure to establish procedures for design control, as required by 21CFR820.30(a). Specifically, your firm has not established and maintained procedures to control the design of your FlashRay dental Xray sensor device to ensure specified design requirements are met. For example,
“A. Procedures for design inputs have not been established, as required by 21 CFR 820.30(c), including procedures to ensure the design requirements are appropriate and address intended use of the device, including the needs of the user and patient.
B. Procedures for design outputs have not been established, as required by 21 CFR 820.30(d), including procedures containing acceptance criteria and those design outputs essential for the proper functioning of the device.
C. Procedures for design review have not been established, as required by 21 CFR 820.30(e).
D. Procedures for design verification have not been established, as required 21 CFR 820.30(f).
E. Procedures for design validation have not been established, as required by 21 CFR 820.30(g), including risk analyses to identify possible hazards associated with the design of your device in both normal and fault conditions.
F. Procedures for design transfer have not been stablished, as required by 21 CFR 820.30(h).
G. Procedures for design change have not been established, as required by 21 CFR 820.30(i).
H. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.300).”
Learn More About 21 CFR 820.30(i) Design Change
Watch the video at the top of this post to learn more about 21 CFR 820.30(i) Design Change and how you can prevent getting a warning letter like this, or click on the course below this post to get an overview of our 21 CFR Part 820 Subpart C – Design Controls online course.