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.

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.

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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We support the draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” with one suggested revision to Section V to help in clarifying who currently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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Letter to Minority Leader Reid Thanking Him for Opposing the Repeal of the Medical Device Excise Tax

As enthusiastic supporters of the Affordable Care Act, we thank you for helping millions of Americans obtain health insurance. We are writing to ask you to vigorously defend the 2.3% excise tax on medical devices, a key provision in the law that provides a significant source of funding.

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Comments on the proposed order on Reclassification of Iontophoresis Devices Intended for Any Other Purposes

We strongly oppose the down classification of iontophoresis devices intended for any other purposes from Class III to Class II (special controls).  This down classification could needlessly expose patients to harm, and would eliminate essential safeguards.

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Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. EPPGs are clearly life-sustaining devices and they should remain in Class III and be reviewed by the more rigorous Premarket Approval (PMA) process, which will better ensure that the devices are safe and effective.

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Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications

We oppose the draft guidance as written and strongly urge the FDA to rewrite it.  The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments.  When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention.

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Comments on De Novo Classification Process

We have serious reservations about the use of the de novo classification process for implants, life-sustaining, and life-saving devices. We believe that all such high-risk devices should be Class III devices reviewed through the more rigorous PMA process. That is why we urge CDRH to revise the draft guidance to explicitly state when the de novo process may be used and when it cannot be used.

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Comments on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

The draft guidance states that the devices identified in the guidance “are sufficiently well understood and do not present risks that require premarket notification (510(k)) review to assure their safety and effectiveness.” We strongly disagree.  Some of the devices do “present risks” and should require the regulatory scrutiny provided by 510(k) premarket notification reviews.

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Comments on the Proposed Rule, “Medical Device Classification Procedures”

We appreciate the opportunity to comment on the proposed rule, “Medical Device Classification Procedures.” The Food and Drug Administration (FDA) is “proposing changes to the definition of class III to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions.” We commend the FDA for seeking clarity but we have grave concerns about the ways that the proposed rule weakens current definitions of class III devices.

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