Biologics Dashboard Glossary

510(k): Also called Pre-Market Notification. An application to the FDA to get approval to market a Class 2 (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: https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k 

Biological Product- Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings." The FDA considers therapeutic biological products a subset of drugs. For more information: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products 

BLA: Biologics License Application. An application to the FDA to be get approval to market a biologics product not exempted in Section 361.  The application must contain sufficient bench, animal and clinical data to convince the FDA the product has sufficient evidence of safety and efficacy.  For more information see: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

CBER: Center for Biologics Evaluation and Research. Branch of FDA that regulates HCT/Ps and biologic products

CDRH: Center for Devices and Radiological Health. Branch of FDA that regulates medical devices

Combination Products: Products that consist of both a device/drug, device/biologic, drug/biologic product, or all 3

HCT/Ps - Human cells, tissues, and cellular and tissue-based products are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient

Homologous Use - One of the four criteria the FDA uses to determine if human cell or tissue product is regulated under Section 361. FDA guidance documents state homologous use is “An HCT/P that performs the same basic function or functions in the recipient as in the donor.” For more information see: https://www.fda.gov/media/109176/download

Humanitarian Device Exemption (HDE):  a marketing application for an HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. https://www.fda.gov/medical-devices/premarket-submissions/humanitarian-device-exemption

Minimally Manipulated – One of four criteria the FDA uses to determine if an human cell or tissue product is regulated under Section 361. For structural tissues, processing must not alter the original characteristics of the tissue’s utility. For cells or non-structural tissues, it must not alter their relevant biological characteristics. For more information see: https://www.fda.gov/media/109176/download

PMA: Pre-Market Approval.  An application to the FDA to get approval to market a 3 (High Risk) devices. The application must contain sufficient bench, animal and clinical data to convince the FDA the product has sufficient evidence of safety and efficacy.  For more information see: https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma

Same Surgical Exception - Human cell or tissue products taken from and replanted into the same patient in the same surgical procedure, and remain “such HCT/P” in their original form, are exempt from regulation. The only treatments allowed are rinsing, cleansing, sizing, and shaping prior to replantation. For more information see: https://www.fda.gov/media/89920/download

“Section 351” – Part of the Public Health Services Act that defines biological products, and how they are regulated if not exempted in Section 361. For more information see: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products 

“Section 361”- Human cells, tissues, and cellular and tissue-based products (HCT/P's) regulated by section 361 of Public Health Service Act. These products must meet the 4 following criteria:

  1. Minimally manipulated 
  2. Homologous Use
  3. Not combined with another article
  4. It does not have a systemic effect or depend on metabolic activity

FDA regulates products in this class only to ensure safety from contamination, degradation, and transmission of communicable disease and does not require proof of efficacy.  For more information see: https://www.fda.gov/media/124138/download

 

Federal Approval Pathways