In light of the US Food and Drug and Administration (FDA) draft guidance on Modified Risk Tobacco Product (MRTP) applications, and the lack of validated self-report instruments, Philip Morris International undertook the development of the Perceived Risk Instrument (PRI) to quantify consumers’ perceived risks of various types of nicotine and tobacco products (including conventional cigarettes, nicotine replacement therapies, and MRTPs). A three-stage development was undertaken following best practice guidelines for self-report instruments. In the first stage, qualitative research was executed to inform upon the development of a conceptual framework and content for a pilot version of the PRI. Two stages of quantitative research (web surveys in US adults; N=2020 and N=1640, respectively) followed to define the final version of the instrument and assess its psychometric properties (based on Rasch Measurement Theory and traditional psychometric methods).The final conceptual framework of the PRI included two main domains: health risk to self and addiction risk. Independent unidimensional scales (18-item Perceived Health Risk scale; 7-item Perceived Addiction Risk scale) were constructed for these domains, complemented by two global items assessing perceived harm to others. Each scale fulfilled Rasch and traditional psychometric criteria (including targeting, reliability based on person separation index and Cronbach’s alpha, and comparability across different populations based on smoking status).The PRI fills an important gap in the research literature and provides a validated instrument for measuring and comparing the perceived risk of tobacco-related products from the consumer’s perspective. By quantifying important aspects of perceived risk, the PRI has the potential to support clinical and population-based studies and an evidence-based product assessment.