October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome (PRO) Instruments for Use in Medical Device Evaluation. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. BIO appreciates the efforts of both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) for the development of the guidance on patient reported outcome (PRO) instruments for use in medical product evaluation. Such guidance is important for supporting patient-centric medical product development and review. BIO recognizes that while PROs are an important tool for collecting and reporting patient experiences, we believe that a patient-centric approach to drug review includes other clinical outcome assessments (COAs) in addition to PROs (e.g., observer, clinician, performance). We encourage CDRH and CBER to consider these other types of COAs when finalizing the guidance. BIO also recognizes there are similar efforts underway in the Center for Drug Evaluation and Research (CDER) focused on the incorporation of patient experiences, and COAs in particular, into drug development and review. While we recognize that the Draft Guidance references CDER guidance, we encourage the Agency…