Statistical Methods are also important for Medical Devices

The topic of statistics has been "established" in the context of process validation for several years now. Ongoing/continued process verification in particular, the third stage in the process validation life cycle of medicinal products/drugs, is generally evaluated using statistical methods.

However, statistics are also necessary in the field of medical devices. In the USA, there is even a separate paragraph in the FDA's Quality System Regulations (QSR, 21 CFR 820). In 21 CFR 820.250 there is a requirement for statistical techniques, also with regard to sampling plans. A recent Warning Letter clearly shows this.

An in-vitro diagnostics manufacturer was asked by the FDA inspector about the reason for the selection of media plates as part of an investigation into a recall involving leaks. The answer was: there is no statistical rationale for sampling five media plates.  Furthermore, the company admitted that there were no work instructions on statistical techniques in the company.

In the conclusion of the Warning Letter, the FDA asks for a response within 15 working days and to specify corrections and corrective actions with timelines in the response letter. Depending on the response, the FDA reserves the right to conduct a re-inspection. Furthermore, documents sent to the FDA should be translated into English.

You can find the entire Warning Letter on the FDA website.