What is orthobiologics?
- Orthobiologics refers to the use of biological substances to help musculoskeletal injuries heal quicker. They are used to improve the healing of fractured bones and injured muscles, tendons and ligaments and are derived from substances that are naturally found in body.
- The substances include bone grafts, autologous blood, platelet-rich plasma (PRP), autologous conditioned serum and stem cells.
- For more information about the Academy’s strategic investment in evidence-based research and education in the field of orthobiologics, click here.
Why did the Academy create the Biologics Dashboard?
- The AAOS Biologics Dashboard was created to assist AAOS Members in navigating the status of biologic-based interventions, including acceptable uses and levels of supporting evidence.
What is the intent of the tool?
- The online dashboard is a dynamic, interactive tool that aggregates the various types of orthobiologics products that are currently available to orthopaedic surgeons in an easily searchable database. It is intended to assist AAOS Members in identifying and interpreting the current status of various biologic treatments, whether they are regulated as human cells, tissues, and cellular and tissue-based products or devices. The dashboard is based on a combination of the most recent and readily available clinical evidence in conjunction with guidance released by the FDA.
Does the AAOS endorse any specific biologic products that are included in the Dashboard?
- The status of any product in the Dashboard does not imply endorsement, efficacy, or appropriateness for use by the AAOS.
- Generally, it should also be noted that the Academy supports protocols issued by the FDA. Continued monitoring of notices and guidelines, as well as continual evolution of the device approval process, help ensure that patients receive safe and effective care.
- To learn more about the AAOS’ position on select orthobiologics products, see the biologics resources page.
Is the dashboard available to the public?
- Only members of the AAOS can access the Dashboard. Members who do not know their account information should select "Forgot my Username" in the AAOS login window to access and update their member profile information.
What committee and/or council oversees the Biologics Dashboard?
- The AAOS Committee on Devices, Biologics & Technology developed and will maintain the AAOS Biologics Dashboard. The AAOS oversees this committee.
How do I use the AAOS Biologics Dashboard?
- Open the AAOS Biologics Dashboard.
- Users must select the tissue type, graft type, how the product is processed (all three of which are typically included on the package insert or information for the doctors from the product itself), and what use the physician is considering. The user will then receive a rationale of the most up to date cited guidance to indicate the current status of the product.
What do the color indicators (green/yellow/red) mean?
- The AAOS Biologics Dashboard includes a three-tier color indicator to help visually illustrate regulatory details. Colors include:
- Green: On-label use of a medical device. For a Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P), clear guidance that it meets the criteria for regulation solely under section 361, has been granted a Biologics License Application (BLA) under section 351, or qualifies for the same surgical procedure exemption.
- Red: For an HCT/P, clear guidance that it does not meet the criteria for regulation solely under section 361 and has not been granted a BLA under section 351. This is true even if the product is produced by a cleared medical device.
- Yellow: Physician-directed use of a medical device that may be controversial. For an HCT/P, unclear guidance as to whether it meets the criteria for regulation solely under section 361. Includes those products produced by a cleared medical device. Biologic products which may not require regulation as HCT/P’s.
If a product or scenario indicates a red light, will it stay that way?
- The “light” indicator is meant to assist AAOS Members in interpreting the current status of a product It is not intended to be a definitive end point. Light statuses will be updated quarterly as both the evidence and the regulatory status of products continuously change.
What information is available about each product?
- Each orthobiologic product shown on the AAOS Biologics Dashboard includes a rationale for current status, the appropriate device approval pathway, regulatory guidance, and references.
The Dashboard uses several acronyms. Is there a glossary available to help me better use the tool?
- Yes, a full glossary is accessible on each page of the Dashboard. In addition, when an acronym is used on the output page, it is always underlined. If the user moves their cursor over the highlighted term, a tooltip will appear to define or provide further contextual information as to how a term is used.
How are biologic treatments regulated?
- Biological products are regulated by the both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). As part of its review, FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations. These control strategies are put in place to help ensure manufacturers produce biological products with consistent clinical performance. Users can access a flow chart that is a helpful visual to provide insight into the regulatory pathways referenced in the dashboard.
What is the 510(K) Pathway?
- Also called Pre-Market Notification, is an application to the FDA to gain approval to market Class II (Moderate Risk) devices. The application must contain sufficient data to convince the FDA the product has sufficient evidence of safety and efficacy; clinical data in human patients is typically not required. For more information see U.S. Food & Drug Administration Premarket Notification 501(k).
What is Section 361 of the Public Health Service (PHS) Act?
- Human cells, tissues, and cellular and tissue-based products (HCT/Ps) are regulated by under this section, which authorizes the FDA to prevent the introduction, transmission, or spread of communicable diseases These products must meet the four following criteria; 1) Minimally manipulated, 2) Homologous Use, 3) Not combined with another article, 4) Does not have a systemic effect or depend on metabolic activity.
What is Section 351 of the PHS Act?
- This section defines biological products that do not meet FDA’s criteria for being regulated as an HTC/P under section 361.
How does the Dashboard align with AAOS’ advocacy priorities and/or relationship with the FDA?
- The Dashboard is an educational tool for AAOS members and is independent of the Association’s policy priorities or positions. The Council on Advocacy remains the governing body to set AAOS’ Unified Advocacy Agenda, while the Association promotes and advocates the viewpoint of the orthopaedic community before federal and state legislative, regulatory, and executive agencies.
Evolution of the AAOS Biologics Dashboard
Who should I contact to provide feedback on the Dashboard?
- The AAOS welcomes feedback to enrich the tool. To share your feedback or ask a specific question, please contact us.
How often will this be updated?
- The AAOS reviews the information within the dashboard on a quarterly basis. As new treatments come on the market and available evidence and federal guidance evolve, the Dashboard will also continue to evolve to best serve AAOS members and their patients.
What role will industry support play in the future expansion of the AAOS Biologics Dashboard?
- The AAOS is not seeking financial support from industry but are interested in collaboration for future Dashboard expansion.
Why did the Academy decide to invest in a biologics-focused portfolio? And how much will the Academy invest?
- An investment of $1.25M will allow for prioritization and execution of key activities to develop and deliver a biologics-focused portfolio within the Academy’s existing business lines. Read more about the AAOS' investment.
How does the AAOS Biologics Dashboard fit into the Academy’s overall investment and orthobiologics programming? What’s next?
- The Dashboard is designed to assist members in interpreting federal guidance documentation for use of biologic products in their own practice. This combined with the evidence-based medicine efforts (technology overviews), advocacy involvement, and education are all geared toward equipping our members to thrive in a value-based environment.