The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve to minimize interference, adherence to certain recommendations will impact companies and procedures in the industry. Click here to view the draft guidance on the FDA web page.

The guideline has some recommendations that many companies already have in place, and should not significantly affect the business. In the “Approval of Molecular Diagnostic Instruments” section, it states that design controls for the instrument and software should be implemented to ensure safety and effectiveness of the diagnostic instrument. Additionally, a risk mitigation plan is recommended to minimize any risks of interference with approved functions. These are practiced widely throughout the industry, and should not impact businesses to any great extent. However, some of the other guidelines may actually cause more confusion than they would prevent.

In the same section, the guideline recommends employing validated procedures following use of functions not requiring FDA approval, in order to ensure the use will not interfere with approved functions. This will greatly impact small to medium sized companies that may use a single diagnostic instrument for combined use. After each use in research and development, for example, these procedures would have to be implemented to ensure interference will not occur. This will almost certainly be of great expense to these companies, and place a strain on their use of the instrument for purposes not requiring approval.

In Sub-section 1, the guidance recommends that the instrument software be programmed to separate the functions into two different pathways at the startup of the application (i.e. the user must choose at startup whether to work with functions that are FDA approved or functions that do not require approval). However, the technicians operating the instrument may be simply following SOPs, and may not be aware of whether the task they are performing is an approved function or a function not requiring approval. This could lead to confusion, and pose additional risks of interference. Furthermore, companies may have an assay that is approved and cleared for use by the FDA, but they may also use the assay for research and development. This, of course, can cause clear problems with determining the specific use of the assay in the eyes of the FDA.

Sub-section 5 recommends informing the FDA of any software changes that has the potential to affect approved functions, including software changes for functions not requiring FDA approval. Since the FDA is burdened as it is and may not have the resources to track these changes, will there be any significant value added to reporting all software changes?

Since the guidelines could have significant impacts to companies and procedures in the industry, we encourage you to submit your comments and observations to the FDA regarding this document. The draft guidance was published on April 9th, 2013, and is open for comment submissions for 90 days after the publication date.

Contact Globiox for expert knowledge to mitigate any of these risks mentioned, improve business processes, and ensure regulatory compliance for your company.

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