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25 Considerations for Companies Seeking Clarity in Design Controls

By John Gagliardi

Since early 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety and effectiveness, is established during the design phase.

FDA believes that unless appropriate design controls are observed during pre-production stages of development, a finished device may be neither safe nor effective for its intended use. This has been true for almost 35 years now. With that being said, some device companies, by their admittance, still struggle with this process and seek clarity.

Forget the convoluted regulatory language for the moment and consider the basic facts.The following is a short list of considerations I have compiled over the years and share with you as key reminders while you’re working through your design controls:

  1. Implementing design controls as a separate entity within the Quality Management System (QMS) is counterproductive and not the way the architecture of 21 CFR, Part 820 was intended.
     
  2. Research is not development. Concept and feasibility is not included in design, per se. Research, though valuable, is not part of a documented design controls process.
     
  3. User needs are not design inputs. Design inputs are measurable.User needs are confirmed during design validation. Design inputs are confirmed during design verification.
     
  4. After design inputs are approved, they are used to verify design outputs, i.e. design verification.
     
  5. Risk analysis is considered a design input, not something that you do later during the process build. The extent of testing conducted should be governed by the risk(s).


Read more design control observations at BONEZONE®. 

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