Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
The design history file establishes the baseline for the design and development of a device.
Is your risk management process rock solid?
Comply all the time, not just when FDA announces an inspection.
Significant changes made to the design or processing of finished medical devices, that are safe and effective in their intended use, require the review and subsequent approval of FDA. This includes changes in the indication for use.
FDA considers the Design History File documented evidence that a medical device was designed and developed in accordance with §820.30; if documented evidence does not exist, FDA will issue a Form 483 observation or even a warning letter.
In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.