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Regulatory Pathway for a Novel Technology

The Situation

An inventor needs to determine a pathway to market for an Electron Paramagnetic Resonance (EPR) biodosimetry device for detection of radiation exposure.

The Solution

RQMIS worked with the client and the FDA and determined that there were no predicate devices for comparison; so, a Pre-IDE submission was executed to determine a regulatory pathway. The Pre-IDE submission opens the door for additional discussions with the FDA.

It's important to choose the correct regulatory pathway for your product - one that makes the most logical sense, will be easily digestible by the regulatory authorities, is financially feasible and takes the least amount of time. When a client has a novel technology that hasn't gone through this process yet, it gives us an opportunity to frame the FDA or competent authority's viewpoint.

BACKGROUND

RQMIS provided a brief summary of the novel technology, a biodosimetry device, to both the Deputy Director of New Device Evaluation and the Deputy Director of the Division of Radiology (FDA/CDRH/OIVDDES) on behalf of the client. This summary described the device as having an intended use to detect whether a person was exposed to radiation as a result of an industrial accident or terrorism. The device was further described as being used in the field by emergency personnel for the purposes of triaging the affected subject population for further medical evaluation and not for medical treatment. After discussing with FDA personnel, it was determined that no predicate were available for comparison.

WHAT WE DID

During negotiations RQMIS reached an agreement with the FDA that the client would complete a Pre-Investigational Device Exemption (IDE) submission to establish the regulatory pathway, for example if they needed to submit a 510(k) versus a PMA. The Pre-IDE submission would contain a product description, labeling, and device schematics, as well as preclinical and clinical test plans.

The client’s phase of development did not fall under the scope of FDA Design Controls (Quality System Regulation). However, RQMIS provided guidance to the client on FDA-compliant Standard Operating Procedures and testing protocols to make the transition to Design Controls less burdensome. In addition, RQMIS provided guidance on FDA compliance requirements specific to what they would need to meet for their clinical studies.

Upon submission of the Pre-IDE, RQMIS met again with the FDA to confirm the regulatory pathway and identify FDA requirements for a future premarket submission. This process made the regulatory pathway very clear for the client, and with RQMIS' guidance and the FDA's backing, they felt comfortable moving forward toward commercialization.

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