Recent Webinar Q&A on User Needs and Design Inputs:

QUES:  User needs / design inputs : could you clarify (maybe with an example) the definition for user needs and design inputs please ?

ANS:  Your SOP should make that definition, as there can be several variations, all acceptable per the CGMPs.  

When I validate, I list all the “ Requirements / expectations by the various stakeholders (including the FDA and other regulatory agencies)” for the item / process / equipment being validated, which include Marketing specs, Standards, Guidance Docs, Company capabilities, etc.  All of these I define as “user needs”, i.e., the user (patient, clinician …) has wants, but expects the device to adhere to safety standards, operating standards, and other considerations necessary in order to produce a safe and effective device. 

These requirements are changed into specific design elements to meet those requirements, and thereby  would drive/define Design Inputs (820.3(f) “…the physical and performance requirements of a device that are used as a basis for device design”.  These would form the initial Design Inputs.  During development, the initial DIs become initial Design Outputs, which in turn become new initial DI and so on until the final DOs are achieved, approved and the Design (documents, et al) is Approved / Transferred / placed into the system for manufacturing.  The FDA discusses this in one of their documents on Design Control (a slide presentation on inspection of 820.30) where they say that only approved DOs need to be retained: however, I usually encourage my clients to include the key transition interim DIs / DOs as well to maintain a usable development history for the company, not only for the FDA. I usually file the interim DIs / DOs under the DO tab in the DHF - define specifics in your company's SOPs.  

-- jel@jelincoln.com

Added additional info on interim DIs / DOs, 12/31/23 - JEL