BLOOD Centers Act Fast-Tracks FDA Approval for New Blood Collection Equipment: 30-Day Deadline Set

The aptly named Boosting Lifesaving Operations, Opening Donation Centers Act—or the BLOOD Centers Act—is all about speeding up the process for blood centers to get new equipment deployed. Basically, this bill creates a regulatory fast-lane at the FDA for established blood centers that want to add new apheresis collection devices, which are used to collect specific blood components, at existing locations. The main goal is to cut down on bureaucratic delays so these centers can expand their capacity faster, potentially helping to stabilize the national blood supply.

The 30-Day Clock for Expansion

Right now, if a blood center wants to use a new piece of collection equipment at a location that wasn't originally licensed for it, they have to file a supplemental Biologics License Application (BLA) with the FDA. This process can take time. This bill mandates that the Secretary of Health and Human Services (acting through the FDA) must establish an expedited process where these specific supplemental applications are approved within just 30 days of submission (SEC. 2). Think of it like getting a pre-approved lane at the DMV—if you meet the criteria, you move fast. For the rest of us, this means that if a center needs to quickly boost its plasma collection capacity, it can deploy the new gear in weeks instead of months, which is a big deal when every unit counts.

Who Gets the Fast Pass?

Not every blood center gets to use this 30-day fast track. To qualify, a center must already hold a BLA for at least one site. On top of that, they must either have FDA approval for three or more sites already, or they must be accredited by an outside organization whose standards the FDA agrees meet or exceed federal requirements (SEC. 2). This is the bill’s way of ensuring that only centers with a proven track record of safety and compliance get the express treatment. It’s a smart move that rewards centers that already run a tight ship, but it does mean smaller or newer centers that don't meet the three-site minimum will still have to go through the standard review process.

The Fine Print on Rejection

The most interesting part of this fast track is how strictly the bill limits the FDA’s power to reject an application. Under this new system, the FDA can only say no if they can prove one of two things: either there is a specific safety concern about the products made at that exact new location, or the center has a “major, systemic failure” at its other licensed locations in meeting safety standards (SEC. 2). This is a high bar for rejection. While it’s designed to prevent unnecessary delays, it puts significant pressure on FDA staff to conduct a thorough review in a very compressed 30-day window. If the definition of “major, systemic failure” gets interpreted loosely, there's a slight risk that oversight could be slightly reduced in the rush to meet the deadline. However, the overall benefit—getting crucial collection equipment into the field faster—seems to outweigh this concern, especially since the eligible centers are already highly regulated.