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BIO Submits Comments on the Establishment of CDRH PEAC

<p>The Biotechnology Industry Organization (BIO) thanks the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for the opportunity to submit comments to the public docket entitled Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments1 (the &ldquo;Public Docket&rdquo;).</p>

The Biotechnology Industry Organization (BIO) thanks the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for the opportunity to submit comments to the public docket entitled Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments1 (the “Public Docket”).

BIO fully supports and applauds the establishment of the Patient Engagement Advisory Committee (PEAC). We strongly believe that placing patients at the center of the development process will significantly improve the development of technologies for interventions that matter most to patients and their caregivers. In tandem with the recent publication of CDRH draft guidance on patient preference information in medical device regulatory submissions, CDRH’s efforts will help enhance the patient voice within the medical product development process and advance the science of patient preference information.