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Dan Crenshaw

 
Dan Crenshaw Image
Title
Representative
Texas's 2nd District
Party Affiliation
Republican
2023
2024
Social Media Accounts
Twitter
: @
RepDanCrenshaw
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Representative Offices
Address
1849 Kingwood Dr.
Suite
#100
City/State/Zip
Kingwood TX, 77339
Phone
713-860-1330
Address
2829 Technology Forest
Suite
#280
City/State/Zip
The Woodlands TX, 77381
Phone
281-640-7720
News
11/15/2024 --healthcareitnews
In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency to clarify guidance that followed 21st Century Cures Act exemptions for clinical decision support from regulation as medical devices."FDA’s guidance does not reflect its typical risk-based approach or consider the significant clinical oversight under which these tools are configured," they said Tuesday.WHY IT MATTERSCongress exempted CDS from regulation as medical devices, provided they meet certain criteria, but lawmakers, led by Dan Crenshaw, R-Texas, and Ann McLane Kuster, D-New Hampshire, provide clear advice."The FDA seems to list internally inconsistent examples of where the exception would apply," they said in a letter shared with Healthcare IT News."For instance, the FDA’s guidance indicates that CDS tools cannot qualify for theexemption unless they provide multiple recommendations."CDS tools often provide a single recommendation when users determine there is only one appropriate option based on clinical practice guidelines."This guidance would seem to make much of CDS used throughout the healthcare system ineligible for the exemption," the lawmakers said, adding that time-critical situations fail the requirement for clinician reviews of CDS recommendations.THE LARGER TRENDThe lawmakers noted that in May the House Committee on Energy and Commerce asked the previous CDRH director, Dr. Jeff Shuren, about specific CDS tools that recommend single courses of action, and said his responses created "additional uncertainty for medical technology developers and providers."Committee members asked Shuren and other FDA division directors what challenges they were facing and why they were not meeting critical performance processes and hiring goals, at times grilling the agency leaders over critical medical device missteps. Shuren said that most medical devices aren't getting to patients due to numerous obstacles from concept to commercialization. "It is appropriately called the valley of death," he said.Crenshaw and Angie Craig, D-Minnesota, wrote to Tarver in September while she served as acting CDRH director after Shuren's departure in July with questions regarding the agency's intentions expressed in the Laboratory Developed Tests Final Rule. That rule would phase out its LDT enforcement discretion policy over a four-year period. ON THE RECORD "Many healthcare organizations deploy hundreds of CDS tools, and providers need clarity to determine whether their tools constitute a medical device and whether they must go through the medical device clearance process accordingly," the lawmakers said in their letter to Tarver."We urge the FDA to revisit its guidance and provide clear advice aligned with the 21st Century Cures Act’s language"Andrea Fox is senior editor of Healthcare IT News.Email: [email protected] IT News is a HIMSS Media publication. Enterprise Taxonomy: AnalyticsAIClinical and business intelligenceRegulationEmerging TechnologiesMachine learningData and InformationPublic PolicyTechnology
11/06/2024 --dailynews_com
At least one-third of the seats will be won by fresh faces since the current officeholders did not seek reelection.
11/06/2024 --laist
With a majority of votes counted in L.A. County, candidates in two of the three open seats on the LAUSD school board appear to have solid leads.
10/14/2024 --columbian
WASHINGTON (AP) — During his first term as president, Donald Trump tested the limits of how he could use the military to achieve policy goals. If given a second term, the Republican and his allies are preparing to go much further, reimagining the military as an all-powerful tool to deploy on U.S. soil.
09/19/2024 --theepochtimes
Lawmakers advanced the bills in hopes of securing a floor vote before the November election.
07/18/2024 --nysun
‘Everyone one of us had questions that we wanted to ask, we felt we didn’t get any of the responses that were necessary,’ one senator tells the director.
11/01/2023 --forbes
Controversial measures in a House-passed immigration bill would likely act as “poison pills” designed to kill aid to Ukraine.
 
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