Not sure about how to make contact with the FDA? Wondering about how to protect your intellectual property? Need advice on your commercialization plan? The Office of Translational Alliances and Coordination has brought together a team of experts skilled in Regulatory Affairs, Intellectual Property, and Business Development. Please contact us to schedule a meeting.
Learn from our community of experts who have created a series of webinars explaining basics of entrepreneurship and biomedical technology development. Topic areas include regulatory, business development, intellectual property, and coverage. Please check out the full playlist of NHLBI Small Biz Hangouts on YouTube and Upcoming Events for information on future hangouts.
Reporting: Final Progress Report Instructions for NHLBI Grantees.
The NIH has released new instructions (83 KB) for preparing your SBIR/STTR Final Progress Reports. View the instructions (83 KB) and the Guide Notice.
Commercialization Assistance Program (CAP)
The NIH Commercialization Assistance Program (CAP) is a FREE specialized technical assistance program for SBIR Phase II awardees. CAP is designed to help promising small life science companies develop their commercial businesses and transition their SBIR-developed technologies into the marketplace. CAP applications are accepted once per year, usually in the Fall. We will post more information here when the program is again selecting applications.
Learn more about CAP
Niche Assessment Program
The NIH SBIR Niche Assessment Program is a FREE nationwide program funded by the NIH to help jump-start an SBIR Phase I awardee's commercialization efforts. Services are provided by Foresight Science and Technology of Providence, RI.
Technology Niche Analyses™ (TNA™) are provided by Foresight for one hundred (100) NIH SBIR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:
Developing a new biomedical product (small molecule and biological drug; gene, cell, or tissue therapy; therapeutic or diagnostic medical device) is a time and money intensive effort. For pre-revenue companies it is especially important that every experiment performed and dollar spent align with getting a first or new product to market.
Designing your research activities to meet regulatory requirements for your innovation takes a different type of research than can be performed in the clinic, at the bench, or in the prototype lab. The links below will guide you to important background information about the United States regulatory processes for drugs, biologics, and medical devices. Additional helpful information can be viewed in the NHLBI Small Biz Hangouts webinar series.
The resources on this page are meant to provide basic information, not to serve as a sole source for understanding how your specific technology will be regulated in the US. If you have questions about how the information on this page applies to your heart, lung, blood, or sleep (HLBS) technology, please contact the NHLBI Regulatory Specialist.
Who are the big players in the United States?
What should I know first?
Where can I get more information?
How do I contact a PERSON to talk about my specific technology questions?
What basic "FDA stuff" do I need to know about my drug or biologic development?
What basic “FDA stuff” do I need to know about developing my therapeutic or diagnostic medical device?
Where can I find information about international regulatory bodies?
In the United States, the 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 their protocols, processes, and approaches to overseeing the development and marketing of biomedical technologies. Many of the links provided in the sections below are maintained by the FDA. For an overview of how to search for information on the FDA website please view the NHLBI Small Biz Hangout Navigating the FDA Website.
The International Council for Harmonization(link is external) (ICH) is a global organization composed of pharmaceutical developers, regulators, and patient groups from many nations in both the developed and developing world. The Council is NOT a regulatory agency itself – rather it was established to harmonize and streamline the global drug development process for the benefit of patients around the world. Many ICH Guidelines(link is external) have been adopted by the FDA.
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). The National Institutes of Health (NIH) is part of 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.
In 1987 the FDA made significant changed to how they regulate drug and biologic development and how they interact with industry and innovators throughout a drugs life cycle. To explain their new regulatory approach, the Agency published the “IND Preamble” in the Federal Register. This document is a must-read for new drug and biologic innovators.
In 1996 the FDA revamped their approach to medical device regulation with a strong focus on Quality Systems Regulation. To explain their new approach to industry, the Agency published the “Quality Systems Regulation Preamble” in the Federal Register. This document is a must-read for new medical device innovators.
Each FDA Center has developed a “Learn” series that includes webinars, slide decks, case studies, and much more. This is a good place to look for information as you begin to learn about biomedical product regulation in the US. The level of complexity of these materials can vary, so you might want to use the titles as a starting point for a broader internet search if the FDA presentation is too technical at your first review.
Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue, and Gene Therapy Learn Series
Center for Drug Evaluation and Research (CDER) Small Business and Industry Education
Center for Devices and Radiological Health CDRH Learn Series
After understanding the basics of how all drugs, biologics, or devices are regulated you will want to know more about your specific technology.
Using very simple search terms you can find FDA guidance documents that will explain the Agency’s current thinking about various aspects of your technology development work. All guidance documents are compiled in a single searchable database .
Through the Freedom of Information Act, FDA is required to release to the public information upon which it bases its regulatory decisions. This information is composed (in part) of marketing approval applications and advisory committee meetings. Applications for approved technologies get redacted, to maintain trade secret information of the innovator; then get posted to one of multiple “Reading Rooms.” Click here to navigate to the home page for all FDA Reading Rooms.
Not all technologies are the subject of an Advisory Committee meeting however, for those that are; presentation materials and transcripts of the public discussion can be found by searching the calendar year links on the left side navigation bar at the Advisory Committee meeting homepage. Typically an Advisory Committee meeting will happen very close in time to an FDA marketing decision so the approval date can guide what year you search.
Clinical development protocols for some cellular or gene therapy technologies are also reviewed by an NIH entity, the Recombinant Advisory Committee. You can view archived webcasts of these proceedings. If you are developing a genetic therapy your project may also need to comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules .
Each Center within FDA has a team dedicated to interacting with the public – both consumers and innovators. Typically you will get a first response within 24 hours, though sometimes it may take 48 hours. These teams may answer your questions directly, may point you toward specific guidance documents or databases, or may refer you to a review division/branch/office. The websites listed below have both phone and email contact information for these teams in the biomedical review Centers.
Center for Biologics Evaluation and Research (CBER) Office of Communication, Outreach and Development
Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance Website
Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education
In addition to these central resources, FDA has field offices across the US. Employees in these offices may be able to address some of your questions, particularly related to manufacturing and quality systems development. To find the office nearest you, look through the FDA Small Business Contacts.
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have a series of formal interactions available to help innovators understand the Agency’s expectations at each major step in a drug or biologic development program. Milestone meetings are described in Formal Meetings Between the FDA and Sponsors (Drugs and Biologics). Throughout your development work you will want much more than the formal interactions described in the document referenced above, recognizing that, FDA as also published Best Practices for Communication Between IND Sponsors and FDA During Drug Development.
All new chemical entities (including biologics) will require clinical investigation under an Investigational New Drug (IND) application prior to market access. The content and format of (IND) applications is explained here. More detail about specific sections can be found with a simple search of the FDA Guidance Database – ex. searching the term “Pharmacology” or “Manufacture” will return several documents that may be relevant to your technology. If you are targeting a special population, such as pediatrics or rare diseases, it’s helpful to also use search terms relevant to those populations.
The Center for Devices and Radiological Health (CDRH) has an iterative interaction program that innovators can access throughout the development of their new technology. This program is described in the guidance document Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff .
Some medical devices require clinical trials to establish their substantial equivalence or safety and efficacy. These clinical investigations occur under an Investigational Device Exemption (IDE). To understand what CDRH is looking for when they review your IDE application please read FDA Decisions for Investigational Device Exemption Clinical Investigations and Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigation Device Exemptions.
Most medical devices will come to the US market through a 510(k) submission by demonstrating “substantial equivalence” (SE) to another currently marketed device. For information about what the FDA looks at when making an SE determination – read The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
Once you have submitted your marketing application you will still talk with CDRH, at a minimum during predefined intervals described in Types of Communication During the Review of Medical Device Submissions.
The National Institute of Allergy and Infectious Diseases (NIAID) collected information from many international regulatory bodies on a single website NIAID ClinRegs - this is a great place to start your regulatory research as you begin the global development of your technology.
Protecting intellectual property (IP) generated during research is an important component of a successful business plan. A company that does not protect its IP rights cannot easily keep competitors from entering its space, and worse, may put itself out of business. Additionally, established companies are uninterested in acquiring unprotected IP from a start-up company, severely limiting the start-up's commercialization or licensing exit strategy.
The best IP protection strategy enables a start-up company to be successful, either by selling or licensing its products or services or by being acquired by a larger, established company.
Early IP protection is important because premature IP disclosure can render the IP unprotectable. Therefore, it is important for an inventor to think about what IP has been generated as a result of the research conducted, how the IP relates to envisioned products or services, and what forms of IP protection might be suitable.
The online resources on this page provide general IP-related information and present a series of user-friendly IP-protection options available to an inventor.
The World Intellectual Property Organization (WIPO) is one of the 17 specialized agencies of the United Nations. WIPO promotes the protection of intellectual property throughout the world and offers an e-tutorial in using and exploiting patent information. Modules include:
IP Awareness Assessment (takes 15-30 minutes to complete)
This tool from the U.S. Patent Office allows an inventor to assess his or her intellectual property awareness and provides customized training materials.
How to Conduct a Patent Search (video)
This step-by-step computer-based training course from the U.S. Patent Office provides online research resources for inventors interested in conducting a thorough search of U.S. patent files.
These six modules on intellectual property protection and enforcement were created by the Global Intellectual Property Academy. They cover all areas of intellectual property protection, including patents, copyrights, trademarks, geographical indications, international enforcement standards, trade, and the patent cooperation treaty.
This series, hosted by the National Council for Entrepreneurial Technology Transfer (NCET2), features in-the-field thought leaders discussing IP issues from an applied, pragmatic, and deeply experienced viewpoint. Topics covered include:
This site from the U.S. Copyright Office contains general information about the copyright process, as well as detailed instructions on conducting copyright searches, recording a document, and licensing procedures.
Trademarks (42-minute broadcast-style video)
This video from the U.S. Patent Office provides basic facts about trademarks. It gives guidelines on how to select the right mark - one that is both federally registrable and legally protectable.
This is a one-stop shop for U.S. government tools and resources on intellectual property rights. It is particularly useful for small and medium-sized enterprises, as well as consumers, government officials, and the general public.
To learn more and speak with an expert contact us at: NHLBI Small Biz Inquiry Form