Dark Daily was recently forwarded a press release entitled Data Innovations Receives FDA Clearance for Instrument Manager. Our first response was to wonder why Data Innovations decided to pursue FDA clearance for Instrument Manager.

After all, in general, laboratory middleware does not require FDA clearance. Furthermore, many laboratory middleware and laboratory information systems (LIS) companies have criticized the FDA whenever, over the past decade, that the federal agency suggested that FDA clearance of laboratory middleware and laboratory information systems should be required. The FDA reasons that regulation is necessary because those products, in effect, practice medicine by providing guidance to pathologists and physicians, which affects patient care.

Dark Daily asked Gregory Vail, CEO of Data Innovations, why the company decided to make the move to get FDA clearance. Vail gave us several reasons:

FDA clearance is required for software used in blood banking and the company’s partners and customers increasingly want to use Instrument Manager in that environment.
Obtaining FDA clearance of the company’s software is a demonstration of Data Innovations’ commitment to the quality process. This extends beyond the development of the software, and includes the procedures and systems that must be put in place throughout the company, such as a CAPA (Corrective and Preventive Action) system.
FDA clearance is of great benefit to the company’s FDA-regulated partners (like in vitro diagnostics manufacturers). It means that, not only is the software FDA-cleared, but also that Data Innovations is FDA inspection-ready.
FDA clearance raises the bar for middleware products and helps the company claim a leadership role in that market.

Our follow-up question to Vail was whether he felt that FDA clearance should be required for laboratory middleware and laboratory information systems in general. “My opinion is that the sophisticated ways in which labs now use middleware and LIS functionality are likely to encourage more regulation,” he responded. “For example, the increased amount of automated functions, such as auto verification, being performed by the software, illustrate how both [laboratory middleware and laboratory information systems] impact patient safety every bit as much as an FDA-regulated laboratory instrument that is used to initially produce a result.”

Pathologists and laboratory administrators should take note of Vail’s observation. He offers a good reason why the FDA would be motivated to bring middleware and laboratory information systems under some form of review and clearance for use in the clinical marketplace. The integration of laboratory informatics is likely to further reinforce this position at the FDA. For example, one reason Vail’s company pursued clearance for its Instrument Manager product is because some laboratory customers wanted to use it in their blood banks. Further, the FDA’s active interest in regulating In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), which incorporate sophisticated software algorithms to generate a test result, may further encourage the agency to require review and clearance for middleware and LIS products.

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Here’s a listing of Pathology Informatics Standards and Web Resources that includes regulations governing laboratory software, prepared by the Association for Pathology Informatics