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Regulatory Pathway for a Novel Technology: Biodosimetry

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 Investigational Device Exemption (IDE) submission was executed to determine a regulatory pathway. The pre IDE submission opens the door for additional discussions with the FDA.

Choosing the pathway to market is major decision with consequences both in time and money.

On behalf of the client, RQMIS provided a brief summary of the biodosimetry device to both the Deputy Director of New Device Evaluation and the Deputy Director of the Division of Radiology (FDA/CDRH/OIVDDES) in which the device was described 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. Subsequent conversations with FDA personnel determined that no predicate devices were available for comparison.

RQMIS reached an agreement with the FDA that the client would submit a preIDE submission to OIVDDES to establish the regulatory pathway -- for example a 510(k) or PMA. The preIDE 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 clinical studies.

Upon submission of the PreIDE, RQMIS met again with the FDA to confirm the regulatory pathway and identify FDA requirements for a future premarket submission.

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