We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label.
Testimony of Dr. Laurén Doamekpor Before the FDA Advisory Panel on Chantix Read More »
We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments.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.
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 That is why we urge CDRH to revise the draft guidance to explicitly state when the de novo process may be used and when it cannot be used.
Comments on De Novo Classification Process Read More »
The draft guidance states that the devices identified in the guidance “are sufficiently well understood and do not present risks that require premarket notification (510(k))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.
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.
Comments on the Proposed Rule, “Medical Device Classification Procedures” Read More »
As members of the Patient, Consumer, and Public Health Coalition, which includes organizations representing patients, consumers, physicians, and scientists, we are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013.
The FDA needs to make sure that the information available on the Internet is as accurate and balanced as possible, and should not rely on companies who make the medical products to voluntarily correct flattering or promotional material about the products they are selling. FDA should require companies to correct this information to the greatest extent possible in order to ensure that consumers are not influenced by misinformation that may harm their health.
Comments on Draft Guidance for Industry on Internet/Social Media Platforms Read More »
We strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. The guidance has the potential to cause confusion and greatly harm patients.
We are writing to express our opposition to the draft guidance Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices. The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree.
We strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death.
Comments on the up-classification of flu detection tests Read More »
