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.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh

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.

Comments of Members of the Patient, Consumer and Public Health Coalition on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

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.

Coalition Supports Proposal to Notify the Public About Emerging Safety Issues with Medical Devices

We support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming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.

Comments in Support of FDA’s Proposed Age Restrictions on Tanning Beds

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.

Comments in Support of FDA’s Proposed Updated Performance Standards for Tanning Devices

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.

Comments of members of the Patient, Consumer, and Public Health Coalition on Medical Device Patient Labeling

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.

Comments on Transfer of Premarket Notification Clearance

We support the draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” with one suggested revision to Section V to help in clarifying who currently holds a 510(k) device. Overall, this guidance will help to ensure that the public information in the FDA’s 510(k) databases are accurate and up-to-date, including the most current owner of a 510(k) device.