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Home » Topics » Regulatory » CDRH

CDRH
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Advamed says FDA should clarify when patient-reported outcome instruments need revalidation

Nov. 3, 2020
By Mark McCarty
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation.
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Advamed says FDA should clarify when patient-reported outcome instruments need revalidation

Nov. 2, 2020
By Mark McCarty
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
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Jeff Shuren
Virtual Medtech Conference

FDA’s Shuren pounds on inadequacy of statute in CDRH town hall

Oct. 6, 2020
By Mark McCarty
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
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Digital illustration of U.S., coronavirus

Trautman: COVID-19 may hamper FDA’s efforts to further harmonize Part 820, ISO 13485

July 17, 2020
By Mark McCarty
The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.
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Coronavirus vs U.S. wrecking balls

Legislators press White House to activate DPA to combat COVID-19

March 24, 2020
By Mark McCarty
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
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Device warnings resurgent despite FDA’s claim Theranos discovery a distraction

Feb. 6, 2020
By Mark McCarty
FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
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Medtronic scores breakthrough device designation for TAAA stent graft system

Oct. 9, 2019
By Liz Hollis
Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).
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Shuren cites need for flexibility, says regulatory Legos the prescription

Sep. 27, 2019
By Mark McCarty
BOSTON – The 2019 Medtech Conference included the annual FDA town hall session, and Jeff Shuren, director of the agency's device center, said the pace of scientific change is outstripping the agency's ability to keep up. Shuren said the solution might be "regulatory Legos," an approach that might eliminate the need to go to Congress for new statutory authorities every time device makers carve open a new technological frontier.
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FDA sustains guidance deluge with draft for conformity assessment

Sep. 23, 2019
By Mark McCarty
The FDA's Center for Devices and Radiological Health has released yet another draft guidance dealing with medical device premarket programs with the release of a draft guidance for the accreditation scheme for conformity assessment. The draft frequently references independent standards for assessing device performance and safety, thus bringing regulatory harmonization one step closer to a practicable reality.
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NEST gaining ground, but access to patient data still a source of drag

Sep. 6, 2019
By Mark McCarty
WASHINGTON – The 2019 annual forum hosted by the Medical Device Innovation Consortium (MDIC) takes place as the National Evaluation System for health Technology (NEST) approaches full operability. Acquiring the data needed to employ NEST as a source of real-world evidence (RWE) is still an issue. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, said that disruption of the business models of the "data oligopolies" is critical for use of RWE for devices in both the pre- and postmarket settings.
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