May 6, 2013
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852
Comments of the Patient, Consumer, and Public Health Coalition on Proposed Order “Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose”
[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 the three preamendment devices referred to in this docket because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness. 1
Regarding the reclassification of sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, members of the Patient, Consumer, and Public Health Coalition strongly opposes the reclassification (from Class III to Class II) as we noted in our May 17, 2012 comments to Docket No. FDA-2012-M-0076. Given FDA’s statement that “the device may lead to the failure to remove drugs in the treatment of poisoning or drug overdose,”1 as one of the reasons for supporting its PMA recommendation, it is inappropriate to down-classify it for any indication.
Below are our specific comments supporting the FDA’s requirement for a PMA for the three pre- amendment devices.
Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances
This device has a long list of health risks including platelet loss, blood loss, hypotension, toxic reactions, metabolic disturbances, and electrical shock. Additionally, there is no proof that the device provides clinical improvement in hepatic coma and metabolic disturbances.1 We strongly support FDA’s Class III PMA recommendation, so that these products could not be sold unless new data are provided that prove their safety and efficacy for this indication.
Cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia
We strongly support FDA’s Class III PMA requirement for this device because currently available data clearly indicate that it is ineffective and poses unreasonable health risks. Eighty-eight published studies on Cranial Electrotherapy Stimulators (CES) “concluded that the device has not been shown to be effective.”1
On February 10, 2012, the Neurological Devices Panel recommended that CES for treatment of depression, anxiety, and insomnia should remain in Class III requiring PMAs. We agree with the panel. We are aware that FDA has received petitions to reclassify the device into Class II for the treatment of depression, anxiety, and insomnia in adult substance abuse patients. We oppose the petitions, because these devices should not be on the market unless a sponsor can prove that they are safe and effective. We note that one of the petitioners’ devices had a Class 2 recall in 2008 involving 3,000 CES devices because they did not have FDA “clearance for the .35Hz/.45Hz frequency option on [the] device.”2
A down classification from Class III to Class II (and 510(k) clearance) would not require a sponsor to prove that their product is safe or effective. Even if the device were cleared by the 510(k) process for a narrower use, it could easily be used off-label for treatments that require a PMA. In other words, down-classification for any indication would create a loophole which would allow manufacturers to avoid the more rigorous PMA review process.
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.
The Patient, Consumer, and Public Health Coalition strongly supports the FDA recommendation to require the PMA review process for these three 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
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 firstname.lastname@example.org
[i] 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]
[ii] U.S. Food and Drug Administration (April 8, 2008). Medical & Radiation Emitting Device Recalls. Class 2 Recall CES Ultra. Recall number Z-0712-2008. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65660.
- 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) ▲
- U.S. Food and Drug Administration (April 8, 2008). Medical & Radiation Emitting Device Recalls. Class 2 Recall CES Ultra. Recall number Z-0712-2008. href=”http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65660″>http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65660. ▲