Devices

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 Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent

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.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent Read More »

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.

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

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.

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

Comments on FDA’s Proposed Reclassification of ECT Devices for Treating Severe Major Depressive Episodes

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.

Comments on FDA’s Proposed Reclassification of ECT Devices for Treating Severe Major Depressive Episodes Read More »

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.

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

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.

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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 of members of the Patient, Consumer, and Public Health Coalition on Medical Device Patient Labeling Read More »

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.

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