DESIGN  REVIEWS  -- HOW  MANY?

I got an e-mail today asking a similar question.  It redirected the reader / was linked to a consulting company.  Basically it mentioned that one review is mandated by the regs - focusing on 21 CFR 820.30, medical device CGMPs on Design Control -  but the website recommended two, one after the Plan and one after V&V.  It also mentioned that additional ones may be advisable.

However, on the U.S. FDA's website, on a webpage dealing with design control guidance:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm

- note:  Figure 1; shows five such reviews.

So what is the actual requirement.  In short, "it depends".

The 820.30 simply states "that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development."  To me this phrase is the key.

Moving beyond fulfilling design control requirements to avoid regulatory problems, to the positive of using such CGMP requirements because they improve a company's products, I recommend in my webinars and workshops that design reviews be used as product development "gates".  Such "gating" is described in the several 'fast cycle' development books that came out in the 1990's.  As such, I use them (and recommend their use) after each significant "milestone" on a Product Development Plan (my preference is a Gantt Chart), to review the completion of that milestone's tasks, and authorize the resources / budget to move on to the next milestone, when linear, or at critical junctures in the project, when reiterative.  Such formally scheduled design reviews are themselves a final task under each key milestone (and/or can also serve as the beginning task for the next milestone, if you're so inclined ).  Then design reviews make business sense, and are not just an exercise in compliance merely for the sake of compliance.

The CGMPs further require that the "participants at each design review include representatives of all functions concerned with the design stage being reviewed", and also include at least one member of the review team "who does not have direct responsibility for the design stage being reviewed", "as well as any specialists needed".  Of course each review - results, design ID, participants, and date, must be documented in the DHF.

-- John E. Lincoln,  jelincoln.com