New FDA Quality Regulations Spark Questions for Ivd Developers, Clinical Labs

While the upcoming regulation, which was released by the FDA earlier this year, is largely the same as the ISO standard, there are key differences between the two sets of rules, which some industry observers are warning could place an overwhelming burden on laboratories that are not prepared to create and maintain manufacturer-level quality systems. And many labs may not be since clinical laboratories aren’t currently subject to the FDA’s quality regulations but will be if the FDA’s quest to regulate laboratory-developed tests is finalized, which is expected to occur sometime this month.

Source: https://www.360dx.com/clinical-lab-management/new-fda-quality-regulations-spark-questions-ivd-developers-clinical-labs