We request that the FDA reverse its policy to exempt many implantable medical devices from directly displaying a UDI number on the implant, and to institute a policy of improved record keeping and record retention.
More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.
FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it. The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore. For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.
Our Coalition strongly supports FDA’s decision to require a pre-market approval review, including clinical trials, to determine the long-term safety and effectiveness of trans-vaginal mesh for pelvic organ prolapse repair. These products were initially allowed on to the market as substantially equivalent to mesh used in other parts of the body, under the 510(k) approval pathway that does not usually require clinical trials or direct scientific evidence of safety or effectiveness.
We strongly oppose allowing companies to promote medical device products for off-label uses. There are not adequate safeguards to allow such promotion to be limited to only scientifically sound, complete and unbiased data. While some patients are helped by off-label uses, many also are harmed by the same poorly-regulated practices.
We strongly oppose allowing the promotion of device products for off-label uses. We believe that there are not adequate safeguards to allow such promotion to be limited to only scientifically sound, complete, and unbiased data.
ECT devices are potentially high-risk devices and should remain as class III and should be subject to PMA review for all indications. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.
We support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed.
We strongly support the proposed rule that bans minors (individuals under the age of 18) from using commercial tanning beds (sunlamp products). However, we think the age limit should be 21, as it is for alcohol, and as it is for cigarettes in more than 100 U.S. cities.
We strongly support the FDA’s proposed rule to update the performance standards for sunlamp products because much stronger standards are necessary to reduce “sunburn, photokeratitis, skin cancer, cataracts, and ocular melanoma” by limiting exposure to UV radiation. However, those standards should be merely a first step. The FDA should go even further to protect the public health by banning commercial sunlamp products entirely.
We strongly support the FDA’s use of objective usability evidence and requiring labels to be written at an appropriate reading level that is easy and interesting to read. However, FDA should focus more on key issues around “advancing development” of labels such as noting on the label if risks and benefits were determined with surrogate endpoints, whether clinical trials were conducted, and whether the device was analyzed on subpopulations.