FDA publishes draft guidance on utilising the Dual 510(k) and CLIA Waiver IVD Market Pathway for IVD manufacturers

New draft guidance from the US Food and Drug Administration (FDA) has been released for In Vitro Diagnostic (IVD) manufacturers using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application registration pathway. The guidance explains the requirements for IVD manufacturers to register for premarket notification.

The dual pathway allows manufactures of new IVD devices faster United States (US) market access than if registrants were to obtain 510(k) clearance and then CLIA waived categorisation in a “stepwise approach”. The Dual Submission registration pathway is most appropriate for simple IVDs subject to 510(k) rather than Premarket Approval (PMA) review.

In order for an IVD registrant to inform the FDA they plan to submit a Dual Submission, it is recommended that the registrant first requests a Pre-Submission meeting. FDA recommends the registrant includes the following in a Dual Submission:

  • A description of the IVD device that demonstrates it is simple to use according to the criteria listed in Section III of FDA CLIA Waiver Application guidance.
  • Results of a risk analysis for the device, including identification of potential sources of error.
  • Description of device’s failure-alert and fail-safe mechanisms, including validation and/or verification studies showing effectiveness of these measures.
  • The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress.
  • The design and results of analytical studies covering sensitivity and specificity, measuring intervals, linearity, precision, reagent and sample stability.
  • Design and results of comparison studies showing insignificant risk of the device’s use by untrained operators.
  • Design and results of reproducibility studies of the device carried out by untrained operators.
  • Proposed device labelling and instructions for use.

The FDA recommends that, when designing comparison and reproducibility studies to support a Dual Submission, applicants evaluate test performance in settings designed to replicate the actual CLIA waived setting and patients.

To read the draft guidance published by the FDA, please click here.