Attachment A - Draft Statement of Work

RFQ 75F40127Q00006

SCIENTIFIC TECHNICAL CAPACITY FOR REGULATORY REVIEW

STATEMENT OF WORK

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

SCIENTIFIC TECHNICAL CAPACITY FOR REGULATORY REVIEW

NAICS Code: 541611 Administrative Management and General Management Consulting Services
RFQ Issue Date: TBD

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STATEMENT OF WORK

SCIENTIFIC TECHNICAL CAPACITY FOR REGULATORY REVIEW

BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
The mission of the FDA’s Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. The CDRH ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products that CDRH oversees. The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and ensuring consumer confidence in devices marketed in the United States. To assist the 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