The US Food and Drug Administrationís (FDA) recent Warning Letter, released 6 June, cites Siemens Healthcare Diagnostics (Medical Device) company who is alleged to have violated federal law by marketing unapproved products.
In a 29 May warning letter sent to medical device manufacturer Siemens Healthcare, FDA alleges the companyís ADVIA Centaur iPTH immunoassay products manufactured at its Tarrytown, NY facility are adulterated because of current good manufacturing practice (CGMP) deficiencies present in their manufacture.
The company allegedly did not establish or maintain adequate design procedures to ensure appropriate design requirements. Specifically, one of the changes was assessed before the validation report was completed, and before effect of the device change on performance was documented, but the company's assessment claimed that there was no change in performance requiring a pre-market submission.
Another change for non PDP project (and regulatory assessment) was reviewed. The regulatory assessment was made nine months before validation report was completed. The effect of the device changes on performance was not documented until these reports were completed, but Siemens assessment claimed that there was no change in performance requiring a pre-market submission.
FDA also said Siemensí Centaur device was misbranded as a result of its failure to make a 510(k) premarket notification to FDA or, alternatively, a premarket approval (PMA) submission.
One of the lessons following this WL is to conduct (and document!) the regulatory assessment in the end of a project (or engineering change) when all the design changes are known, and not only in the beginning of a project.