Author name: PCeditor

Comments on Classification of Medical Cribs

FDA should test drop-rail cribs for safety, since there are well-established and serious risks.  We oppose the FDA proposed rule as currently written because it would not require any safety testing data be reviewed by the FDA.  However, even if that part of the proposed rule were revised, the proposed rule would still create an enormous loophole that would allow widespread use of cribs outside of healthcare settings, as noted above.

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Comments on the Establishment of the Patient Engagement Advisory Committee

We are concerned about the establishment of a stand-alone Patient Engagement Advisory Committee for medical devices. It is not clear whether this committee will isolate rather than integrate the voices of patients into CDRH decision-making. We support both patient representatives and consumer representatives becoming voting members on the current medical device advisory committee with its 18 panels.

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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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Letter to Senators Alexander and Murray supporting efforts to improve the Innovations for Healthier Americans initiative

We strongly  support  the Senate Committee on Health, Education, Labor, and Pensions (HELP) Committee’s efforts to improve patients’ access to safe and effective medical products in a timely manner  through the Innovations for Healthier Americans initiative. We urge the Committee to consider the inclusion of components of the Research for All Act of 2015 within the legislative text of the Innovations initiative.

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Comments on Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age

We believe that pregnant women’s daily exposures to phthalates since 2005-6 are likely to be similar to other women of reproductive age (WORA).  The new report indicates that some of those exposures have increased and others have decreased, presumably reflecting changes in products more than changes in women’s habits. It is alarming that the daily intake of DINP has increased. We strongly support the plan to make the interim ban on DINP a permanent one.

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Letter to Congressman Cooper supporting Research for All Act of 2015

We strongly support the Research for All Act.  It would require the FDA to develop policies to ensure that clinical trials for medical products granted expedited approval are sufficient in design and size to determine the safety and effectiveness for men and women, using subgroup analysis.  The Act also increases the study of female animals, tissues, and cells in basic research conducted or supported by NIH.

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Comments on Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates

The coalition strongly supports most provisions of the proposed rule on the “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.”  However, we are disappointed with some of the provisions described above and strongly disagree with the CPSC regarding DIOP.  In the final rule we recommend that the CPSC protect the health of consumers by permanently banning DIOP.

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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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Comments from Members of the Patient, Consumer, and Public Health Coalition on Innovation for Healthier Americans

The aim of the white paper is “to examine the current process of drug and device development and identify inefficiencies” and examine what is and is not working at NIH and FDA (p vi). We strongly support that. However, we do not support the goal of “accelerating medical innovation and patient access to important medicines and medical technologies” (p. vii) because safety and effectiveness is not included in that goal.

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