Abstract
With increased utilization of platelet-rich plasma (PRP), it is important for clinicians
to understand the United States, the Food and Drug Administration (FDA) regulatory
role and stance on PRP. Blood products such as PRP fall under the prevue of FDA's
Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating
human cells, tissues, and cellular and tissue-based products. The regulatory process
for these products is described in the FDA's 21 CFR 1271 of the Code of Regulations.
Under these regulations, certain products including blood products such as PRP are
exempt and therefore do not follow the FDA's traditional regulatory pathway that includes
animal studies and clinical trials. The 510(k) application is the pathway used to
bring PRP preparation systems to the market. The 510(k) application allows devices
that are “substantially equivalent” to a currently marketed device to come to the
market. There are numerous PRP preparation systems on the market today with FDA clearance;
however, nearly all of these systems have 510(k) clearance for producing platelet-rich
preparations intended to be used to mix with bone graft materials to enhance bone
graft handling properties in orthopedic practices. The use of PRP outside this setting,
for example, an office injection, would be considered “off label.” Clinicians are
free to use a product off-label as long as certain responsibilities are met. Per CBER,
when the intent is the practice of medicine, clinicians “have the responsibility to
be well informed about the product, to base its use on firm scientific rationale and
on sound medical evidence, and to maintain records of the product's use and effects.”
Finally, despite PRP being exempted, the language in 21 CFR 1271 has caused some recent
concern over activated PRP; however to date, the FDA has not attempted to regulate
activated PRP. Clinicians using activated PRP should be mindful of these concerns
and continued to stay informed.
Keywords
platelet-rich plasma - PRP - regulations - FDA
