Quality System Regulation
Another open question relates to the applicability of the FDA Quality System Regulation (QSR), which governs the manufacture of devices. Device manufacturers must comply with QSR requirements.
In contrast, laboratories need to meet CLIA requirements. While there are some common areas, the two systems do differ. The QSR regulations, for example, mandate that devices be developed in accordance with design controls. CLIA has no counterpart provision.
When FDA first proposed the IVDMIA guidance, the laboratory industry cited difficulties in operating in both a CLIA and QSR regime. FDA has recognized that applying these dual regulatory schemes to laboratories will create challenges. Although a number of suggestions were floated, e.g., delaying applicability of QSRs to laboratories or using CLIA inspections in lieu of FDA QSR inspections, no clear solution has been identified.
This is hardly an exhaustive list of issues. For example, reconciling FDA regulation of device labeling and CLIA requirements for communicating results to doctors will not be simple. FDA restricts communications by device companies to the FDA cleared or approved intended use. CLIA mandates more open communications. The devil is in the details, and applying device regulation to LDTs will generate many details that need to be addressed.
Nobody at the meeting disputed that LDTs play a vital role in healthcare. Nor was there much disagreement that FDA should scrutinize in some manner some higher-risk tests. However, converting these broad principles into fair, concrete, predictable regulatory requirements that will provide patient protection but not deter innovation or unduly hamper access to tests will be a daunting task indeed.