In a recently posted FDA warning letter, the FDA cited a firm for failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).  Items missing in the Standard Operating Procedure (SOP) included identifying who is responsible for the design and development planning activities, how the design project will be planned, and the requirements for design planning.

The firm provided a copy of the revised SOP to the FDA that includes the missing requirements [A correction] however, the firm’s response was deemed inadequate by the FDA in that the firm did not:

  • provide documentation that employees were trained on these new procedures,
  • that a correction and corrective action were implemented,
  • and that a systemic corrective action was considered to include a retrospective review of design and development planning activities for other devices

Lessons learned:

When responding to the FDA simply revising and submitting the new SOP [A correction] is not an adequate response.  The FDA would expect the firm to revise the SOP, provide documentation of training on the new SOP, and a confirmation that the specific observation i.e., the missing design and development plan (or missing elements) had been addressed.  It may be necessary to demonstrate efficacy of the change (with applicable statistical measures).

Additionally in this case, because the same SOP, that was identified by the FDA as deficient, may have governed the design and development for all other devices manufactured by the firm.  It would be appropriate for the firm to have continued the investigation to identify the true scope of the problem.

An observation (from my personal experience) in setting milestone dates in responses to the FDA.  Often these dates are established by upper management with limited input from the managers who are actually responsible for completing the work.  Additionally, the time and effort required to fully respond to the FDA is often underestimated.  This is especially true when the in-house staff will be responsible for both remediation activities and their day-jobs.  In my opinion, it is much easier to respond with more realistic dates to the FDA than to provide aggressive dates and then have to ask for time extensions (sometimes multiple extensions) to complete planned activities.

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