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FDA/CDRH Scientific Technical Capacity for Regulatory Review

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Description

This is not a solicitation announcement. This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes � it does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFQ, if issued. The purpose of this SSN is to gain knowledge of potential qualified vendors, including large business sources, small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-Owned, Veteran-Owned, Women-Owned Small Business, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code. Responses to this SSN will be used by the Government to make appropriate determinations about potential sources. Project Title: FDA/CDRH Scientific Technical Capacity for Regulatory Review Background: To assist the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) in fulfilling its mission, CDRH seeks expert consultants to assist CDRH�s Offices with regulatory review across the total product lifecycle. CDRH requires consultants that have skilled experience to assist with medical device regulatory review work and supporting scientific activities, such as research, cybersecurity and digital health consultations, regulatory consultations and auditing, and interacting with industry and patients. The CDRH requires consultants that have sufficient skilled capacity in many science, engineering, and clinical specialties, including Anesthesiology, Biology, Biomedical Engineering, Chemistry, Clinical laboratory testing, Computer Science and Engineering, Consumer Safety, Cybersecurity, Data Science, Dentistry, Digital Health, Epidemiology, Gastroenterology, General Engineering, Health Science, Infectious Diseases, Interdisciplinary Engineer/Scientist, Molecular testing, Neurology, Optics, Patient Engagement, Physics, Psychiatry, Public Health, Pulmonology, Reprocessing medical devices, Social Scientist, Software Engineering, Statistics and Biostatistics, Sterilization, Toxicology, Urology, Veterinary Medicine, and Virology. Objective: The primary objective of this effort is to provide the CDRH with a vehicle to acquire the support services of advanced professional and scientific consultants to assist CDRH�s Offices with regulatory review across the total product lifecycle, including the supporting scientific, engineering, clinical, and regulatory activities. The services provided will …