Unique Requirements for Biotech and Medtech Ventures
- Biotechnology products often require regulatory approval, e.g., Food and Drug Administration (FDA) approval.
- The FDA regulates medical devices, radiological health, over-the-counter drugs, prescription drugs, biological therapeutics, and biological products, including certain human cells and tissue products, medical test kits, and drug products (Registrar, 2023). Obtaining FDA approval for your product is an important hurdle to clear before a successful product launch. Safety, efficacy, and manufacturing controls are needed for FDA approval. You may need to modify the product in response to obtaining regulatory approval.
- If yours is a biomedical product, make sure that health insurance will pay for the use of the product or the medical procedure for which it will be used (ULP, 2022).
US Food and Drug Administration – Official website.
FDA Resources – NCI SBIR Development Center.
How to Get FDA Approval – Registrar Corp. 2021.
FDA Review and Approval – A toolkit provided by NCATS.
CARE Regulatory Program – A support offered by NCI for communication between small businesses and regulatory experts at the FDA.
3 Key Medical Device Reimbursement Challenges Manufacturers Face Globally – Infiniti Research.
Breaking the Myths of Medical Device Reimbursement – MediClever Reimbursement Consultants.
Health Insurance Coverage and Reimbursement Decisions – Issue Brief. American Academy of Actuaries. 2008.
FDA Small Business Assistance – Includes the. . .
- Center for Biologics Evaluation and Research (CBER)
- Center for Drug Evaluation and Research (CDER)
- Office of Regulatory Affairs (ORA) district offices and small business representatives
Licenses and Permits
Depending on the nature of your business and location, you may need various federal and state licenses and permits for your small business (SBA, 2023). Become aware of the fees and waiting periods involved. Keep track of expiration and renewal dates. Here are two examples:
- Sellers permit – If you sell tangible items to the public, you may need this permit from your state.
- If a federal agency regulates your business activities, you need a permit or license. For example, in agriculture, if you import or transport animals, animal products, biologics, biotechnology—including genetically engineered organisms—or plants across state lines, check with the US Department of Agriculture. The SBA resource, “Apply for licenses and permits,” describes many of these licenses and permits unique to each industry.
Resources on Licenses and Permits
Apply for licenses and permits – Small Business Administration resource that describes federal licenses and permits organized by business activity and advises how to find information on state licenses and permits.
The Small Business Administration (SBA) website is a good place to start when founding a business. These two pages may be particularly helpful: