Comments on Proposed Order Regarding Transilluminator for Breast Evaluation

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852

May 6, 2013

Comments of Members of the Patient, Consumer, and Public Health Coalition
on Proposed Order
Regarding Transilluminator for breast evaluation
[Docket No. FDA-2013-N-0195]

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for Transilluminator for breast evaluation devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1]

Transilluminator for breast evaluation

We strongly support FDA’s Class III PMA requirement for transilluminators for breast evaluation.  There is insufficient evidence that they work and the health risks related to the device include electrical shock and missed or delayed diagnosis for breast cancer. It is essential that the controls inherent in the PMA process be required so that companies would need to prove that their product is safe and effective and it would be subject to inspections to ensure that it is made to specifications.

Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA recommendation to require the PMA review process for transilluminator for breast evaluation devices.  They have substantial health risks and lack “valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness.”

Center for Medical Consumers
Connecticut Center for Patient Safety
Consumers Union
National Research Center for Women & Families
National Women’s Health Network
The TMJ Association

For more information, contact Paul Brown at (202) 223-4000 or



[1] Federal Register (April 4, 2013).  Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose. [Docket No. FDA-2013-N-0195]