Take Action: AABB Initiates New Action Alert to Oppose Proposed FDA Rule Regulating LDTs

AABB introduced a new action alert today to empower the blood and biotherapies community to take action to oppose a rule proposed by the Food and Drug Administration that would regulate laboratory-developed tests (LDTs). As described in an AABB summary, the proposed rule takes a sweeping approach to categorizing in vitro diagnostic products as LDTs, which would be subject to medical device regulations and user fees.

Members of the blood and biotherapies community are encouraged to act now to let FDA know why the proposed regulation governing LDTs is overly burdensome and unnecessary. As part of the action alert, AABB has prepared an outline to help members develop and submit comments that illustrate how the proposed rule will impact their work. Additionally, the action alert makes it easy to send comments directly to regulations.gov.

The Association will also submit a formal response opposing the proposed rule and highlighting the potential negative impact on blood establishments, hospitals’ transfusion services, and accredited cell and gene therapy laboratories and services.

Join AABB in this critical fight to protect the blood and biotherapies community from unnecessary and burdensome regulations. Taking action today can make a significant difference in ensuring timely and quality patient care.