NHLBI SBIR/STTR Resources

The following lists and links provide basic information and should not serve as sole sources for understanding the topics presented. If you have questions about how the information applies to your heart, lung, blood, or sleep (HLBS) technology, please contact the NHLBI Innovation and Commercialization Office (I&C) using the Small Business Inquiry Form.

Regulatory Resources

Which organizations and agencies should I know?

The U.S. Food and Drug Administration (FDA) is the primary regulatory body for biomedical technology development. The FDA provides an abundance of information to help innovators understand the protocols, processes, and approaches it uses to oversee the development and marketing of biomedical technologies. Many of the links provided in the sections below are maintained by the FDA.
The FDA provides information about International Regulatory Harmonization, a process used by regulatory authorities to align technical requirements for the development and marketing of pharmaceutical products.
The U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of people involved in research conducted or supported by the HHS.
If your technology uses wireless communication, you may need to be aware of and compliant with some Federal Communications Commission regulations. Find out more at Connect2HealthFCC.
The Innovators’ Guide to Navigating Medicare helps the Centers for Medicare & Medicaid Services (CMS) stakeholders understand the processes used to determine coverage, coding, and payment for new technologies under the Medicare fee-for-service program.

Where should I start to learn more about regulations and regulatory bodies?

For drugs and biologics

Read about FDA’s regulatory approach to drug and biologic development and interactions with industry

Federal Register

Watch web-based courses from the FDA Center for Drug Evaluation and Research (CDER)

CDERLearn Training and Education

Take an industry education course through FDA’s Center for Biologics, Evaluation and Research (CBER).

CBER's OTAT Learn

Learn about CDER and CBER milestone meetings to help innovators understand expectations at each milestone.

Formal Meetings Between the FDA and Sponsors or Applicants

Read Best Practices for Communication Between IND Sponsors and FDA During Drug Development

FDA Good Review Practices

Become familiar with the FDA’s content and format of investigational new drug applications

FDA Guidance Document

For devices

Learn about the FDA’s approach to medical device regulation, including its strong focus on quality systems regulation

Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality…

Explore learning modules from the FDA Center for Devices and Radiological Health (CDRH).

CDRH Learn

Become familiar with the FDA’s Requests for Feedback and Meetings for Medical Device Submissions

The Q-Submission Program

Learn about FDA resources for substantial equivalence and medical device clinical trials

The 510(k) Program

Read about FDA Decisions for Investigational Device Exemption Clinical Investigations

FDA Guidance Document

Learn about Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

FDA Guidance Document

Read about Types of Communication During the Review of Medical Device Submissions

FDA Guidance Document

Where can I find more general guidance?

FDA’s Guidance Documents provide information about regulatory approaches about drugs, biologics, devices, etc. and can be found using simple search terms in its searchable database.
FDA complies with the Freedom of Information Act by posting information from technology applications it has approved to one of multiple reading rooms. This information comes with redactions to maintain trade secrets. The agency always posts marketing approval applications and minutes from advisory committee meetings. FDA keeps a list of document categories and links to their reading rooms on its website.
Presentation materials and transcripts of public discussion at Advisory Committee meetings are available by searching FDA’s Advisory Committee Calendar.
Clinical development protocols for some cellular and gene therapy technologies are also reviewed by NIH’s Novel and Exceptional Technology and Research Advisory Committee (NExTRACT).
Those developing a genetic therapy may also need to comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Who can I contact at the FDA to talk about my specific technology questions?

FDA Centers often have teams dedicated to interacting with the public, including innovators. Responses typically take 24 to 48 hours. They may include direct answers to your questions, specific guidance documents or databases you can access, or referrals to offices that may be able to help, such as the ones below:

Center for Biologics Evaluation and Research (CBER) contacts
Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (scroll down for an email address and phone number)
Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education contacts

FDA also has field offices across the country with staff that may be able to address some of your questions, particularly those related to manufacturing and quality systems development. Find the office nearest you in the FDA Small Business Contacts list.

Find the office nearest you in the FDA Small Business Contacts list.

Where can I find information about international regulatory bodies?

The National Institute of Allergy and Infectious Diseases (NIAID) collected information from many international regulatory bodies and made the information accessible on its website.

Learn more about NIAID ClinRegs