FDA’s Design Controls regulation can be an open book but sometimes hard to read. Interpretations of the various regulatory requirements contained within 21 CFR 820.30 can vary both between and within life science organizations. The challenge becomes interpreting the requirements and implementing them into your development processes in such a way that does not negatively impact product quality or your larger quality system.
We’ve heard a lot about the open-ended nature of Design Controls regulation, and we can relate; many requirements of 21 CFR 820.30 can be difficult to approach as a result. The issues span across the board, but there are six common misunderstandings we think are worth addressing when it comes to interpreting FDA’s Design Controls.
Although FDA does not require specific risk management activities, some organizations incorrectly believe risk analysis is not an explicit requirement for life science product development. However, in the requirements for design validation, FDA states that “design validation shall include software validation and risk analysis, where appropriate.” It falls under the umbrella of validation and must therefore be treated accordingly.
Playing on the conservative side when it comes to building and managing design & development plans for your life science product is not an unreasonable approach. However, fear of rejection or other issues that could delay regulatory submission can cause teams to become too rigidly stuck to those plans. FDA’s Design Controls regulation allows for flexibility in these plans, however, and that should be leveraged when appropriate.
Aside from design controls not happening sequentially, they don’t happen just once, either. Throughout the product development process, your teams need to come back into your design control stages to build on existing data, add new pieces of information, test new components/systems/subsystems, and so on. Doing your best to control the amount of time invested into different quality processes is necessary for ensuring time to market, but a single round of design controls can be more harmful than beneficial over time.