Questions from my recent webinar on the Master Validation Plan:

My response:

 

Ques. 1: How would you structure or link design documentation for a hardware system and the disposable sets used on that system?

Ans: It depends on whether the disposables are your company's designs/ supplied by you, or purchased separately from another company by the user.  If yours, you would address them / their design/risk the same as the basic system, either in the system's DHF, or in additional / supplemental DHF's, referencing the original DHF.  If another company's, you would address your product's interfaces to the outside products, for all that you claim compatibility with, e.g., standard luer fittings, et al, in your DHF / Risk files. 

Ques.2: On Risk Management Files, you say that overall residual product risk is acceptable and that not every residual risk must be disclosed. 

ANS:  If the supporting data, FME[C]As, FTA, et al, show residual risk then you make the determination as to whether the residual risk is acceptable and analyze that conslusion in your Benefit / Risk (to patient/user) Analysis .  All residual risks are shown in the supporting documents, FTA, FME[C]As..., but not all have to be specifically analyzed, only those that pose important risks to the user/patient. 

 

(A) How would you summarize individual risk into an overall product risk?

ANS:  That's a decision your company's product experts would have to determine, and define in your design control DHF / Risk Management File SOP(s).  The overall Product Risk is the sum total of all your product's individual risks from design issues, production failures, and use errors, etc.

 

(B)Would you not disclose your full FMEA document to the FDA?

ANS: Of course you'd disclose it/them..  Your DHF and Risk Management File ( and Human Factors File, if used) are all to be accessible to an FDA inspector, and some may be submitted to the FDA in a Marketing Authorization submission (510(k), De Novo, PMA...) to show your product's risk in general and in relation to a predicate device, or in response to a 483 remediation, or ...

-- jel@jelincoln.com  05/18/2026