Author name: PCeditor

Comments on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

The draft guidance states that the use of consensus standards will “streamline premarket review” and “facilitate market entry for safe and effective medical products.”  We support a more efficient process, but are concerned about the potential for lowering the standards for safety and effectiveness since the draft guidance states that one of the purposes of declaring conformance with a consensus standard is to “reduce the amount of supporting data and information that are submitted to FDA.” We would strongly oppose any reduction in the already limited information regarding safety, effectiveness, or substantial equivalence.

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Coalition strongly supports the FDA’s proposal to upclassify surgical mesh for POP repair and surgical mesh instrumentation

We are writing to express our strong support for the FDA’s proposal to upclassify both surgical mesh for POP repair and surgical mesh instrumentation. This change will help to ensure that devices intended to improve women’s heath are supported by evidence of safety and effectiveness. We would also like to express our strong concerns that the agency has not proposed reclassification of surgical mesh for stress urinary incontinence (SUI) from class II to class III.

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Comments opposing FDA’s draft guidance on postmarket safety and effectiveness data for high-risk devices

We are writing to express our strong concerns about the draft guidance for the “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.” The standards for PMA are currently much lower than for prescription drugs, despite the fact that the 1% of devices approved through the PMA process are life-saving and life-sustaining products, which many prescription drugs are not.  The draft guidance has the potential to lower those standards even more, by increasingly relying on postmarket safety and effectiveness data rather than pre-market data, thus putting patients at greater risk.

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Comments Opposing FDA’s Draft Guidance on Speeding Access to High Risk Medical Devices

We do not support the draft guidance for the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” The standards for PMA are already substantially lower than for prescription drugs. Most PMA devices are approved through supplements that do not require clinical trials. Original PMA clinical trials are often small and short-term with limited use of control groups.  And yet, the draft guidance lowers the bar for certain PMA medical devices even further.

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Coalition Concerned that Proposed Regulatory Framework for Health Information Technology will Undermine the FDA’s Mission to Protect the Public Health

We do not support the FDA’s Safety and Innovation act as we believe it will undermine the FDA’s mission to protect the public health. The framework “primarily relies” on the ONC and private sector capabilities to coordinate activities with FDA and FCC, which leaves the FDA in a secondary role. The FDA has overseen medical devices, including medical device software, for nearly four decades. The Agency has been regulating software on mobile platforms for more than a decade and has cleared approximately 100 mobile medical apps such as ECG machines and smartphone based ultrasounds.

Coalition Concerned that Proposed Regulatory Framework for Health Information Technology will Undermine the FDA’s Mission to Protect the Public Health Read More »

Letter to Congresswoman DeGette Expressing Concerns about 21st Century Cures

The Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, writes to express our concerns with in the 21st Century Cures project. We request that future discussions include representatives from our Coalition.  We believe that we bring an essential perspective and valuable expertise.

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Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014

The Honorable Jim Cooper 1536 Longworth HOB Washington, DC 20515 Re: Members of the Patient, Consumer, and Public Health Coalition strongly support the Research for All Act of 2014. Dear Congressman Cooper, As members of the Patient, Consumer, and Public Health Coalition, we strongly support the Research for All Act.  It would require the FDA

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Comments from Coalition On the Department of Health and Human Services (HHS) Proposed Rule “Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements”

We strongly encourage ONC to include automatic identification and data capture (AIDC) such as bar codes in its 2015 Edition and not wait until the 2017 Edition.  Using an AIDC system saves physicians time and is more accurate (it avoids human error such as transposing of numbers). Adding UDI information to EHRs would improve patient care in several ways.

Comments from Coalition On the Department of Health and Human Services (HHS) Proposed Rule “Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements” Read More »

Comments from the Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements”

We applaud FDA’s efforts to clearly and effectively communicate risks and benefits to consumers in direct-to-consumer (DTC) advertisements.  However, we are concerned about this study’s definition of “serious and actionable” risks, the diversity of the population being studied, the administration of the study in an online setting only, and the timing of the major statement in the ad (at the end of the ad instead of the beginning or middle).

Comments from the Coalition on research entitled “Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements” Read More »