The American College of Radiology warns of patient care disruptions and asks for expedited review of alternative devices.
The American College of Radiology (ACR) is alerting federal officials to patient care disruptions tied to a long-term shortage of stereotactic breast biopsy needles. In a May 11 letter to the Food and Drug Administration (FDA), the ACR shared clinical concerns and called for collaboration and information sharing to support the imaging community.
The shortage began earlier in 2026 after a major manufacturer stopped shipments to correct a production issue, according to the ACR. Limited alternatives have not met clinical demand, straining the supply chain. The FDA added the shortage to its Medical Device Shortages List in mid-April and expects supply issues to ease around the fourth quarter of 2026.
“According to widespread reports from the breast imaging community, these shortages are creating immediate and substantial challenges for breast imaging practices nationwide, negatively impacting patient access to diagnostic care, and ultimately, to critical therapeutic intervention,” says Dana H Smetherman, MD, CEO of the American College of Radiology, in the letter to the FDA.
Impact on Patient Care
Image-guided breast biopsy is a primary tool for breast cancer diagnosis. According to the ACR, limited access to these devices directly impacts patient care by:
- Delaying the diagnosis of suspicious breast lesions and the start of therapy.
- Increasing patient uncertainty regarding clinical outcomes.
- Potentially leading to more invasive, costly, or less optimal diagnostic pathways.
- Creating inefficiencies in strained imaging workflows.
The ACR notes that the backlog represents a public health concern, particularly in high-volume centers and safety-net institutions where alternative devices may be unavailable.
Proposed Solutions and Collaboration
The ACR requested that the FDA take several actions to support supply chain resilience and ensure continuity of care. These recommendations include expedited review and regulatory flexibility for alternative or equivalent biopsy devices to help alleviate constraints.
The ACR also suggested the facilitation of enforcement discretion or streamlined pathways to allow the temporary importation of comparable biopsy devices that meet safety and quality standards. Additionally, the college urged the FDA to engage with manufacturers to encourage the prioritization of production and the development of reserve inventory.
The communication effort was led by the ACR Commission on Breast Imaging after experts raised concerns during the college’s annual meeting. These discussions triggered the ACR Quick Response Team process, which is designed to address supply chain issues.
The ACR and the breast imaging community remain committed to working with the FDA to ensure access to diagnostic tools and safeguard timely care for patients, according to the letter.
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