FDA Regulation of Oncology-related Technologies
The NCI SBIR Development Center connects entrepreneurs with regulatory centers at the US Food and Drug Administration (FDA). These curated links contain resources that are relevant for early-stage companies developing oncology-related technologies.
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FDA Center for Devices and Radiological Health (CDRH)
FDA regulates medical devices to assure their safety and effectiveness, and develops and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program.
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FDA Center for Drug Evaluation and Research (CDER)
FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER's best-known job is to evaluate new drugs before they can be sold. The Center makes sure that safe and effective drugs are available to improve the health of consumers.
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FDA Center for Biologics Evaluation and Research (CBER)
The FDA Center for Biologics Evaluation and Research (CBER) regulates biological products, certain human cells and tissue products (HCT/Ps), certain medical devices, HIV test kits and certain drug products.
I’m unsure who regulates my technology
- Is my technology regulated by CDRH?
- Is my therapeutic biological product regulated by CDER or CBER?
- Is my software considered a medical device?
FDA Events and Training
CDRH Events and Training
CDER Events and Training
CBER Events and Training
Contact NCI SBIR
If you have any questions or suggestions for additional resources, please contact NCI SBIR Development Center Program Director Monique Pond (monique.pond@nih.gov).
Frequently Asked Questions (FAQs) about FDA Regulation of Oncology-related Technologies
How do I contact the FDA?
Contact the FDA center that regulates your technology category.
- Contact the Center for Devices and Radiological Health (CDRH)
- Contact the Center for Drug Evaluation and Research (CDER)
- Contact the Center for Biologics Evaluation and Research (CBER)
What information is needed for a pre-submission meeting with FDA?
Information needed for pre-submission varies for each of the FDA centers.
- Information needed for a pre-submission meeting with the Center for Devices and Radiological Health (CDRH): Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Information needed for a pre-submission meeting with the Center for Drug Evaluation and Research (CDER): Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
- Information needed for a pre-submission meeting with the Center for Biologics Evaluation and Research (CBER): Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meetings
What testing requirements/studies are needed to support an Investigational Device Exemption (IDE)?
Overview: Investigational Device Exemption (IDE)
Where can I find information on regulations for laboratory developed tests?
Clinical Laboratory Improvement Amendments (CLIA)
Does my tool qualify for the Medical Device Development Tools (MDDT) program?
Medical Device Development Tools (MDDT)
Is Premarket Notification 510(k) or Premarket Approval (PMA) required for my device?
Can my device be reviewed by FDA and Centers for Medicare and Medicaid Services (CMS) in parallel?
Payor Communication Task Force
What should I know for my pre-IND meeting?
Is my therapy eligible for the Regenerative Medicine Advanced Therapy (RMAT) designation?