FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Rome, Benjamin N.; Kramer, Daniel B.; Kesselheim, Aaron S.

doi:10.1001/jama.2013.284986

Cited by 61 publications

(103 citation statements)

References 10 publications

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“…Although the expectation is that individual postmarket device changes will have a limited effect on device safety or effectiveness, cumulative iterations of device changes may cause ''drift'' away from the originally approved device design. A previous study of PMA supplements found that cardiac implantable electronic devices underwent more than 30 postmarket changes to device design or labeling that often were not supported by new clinical data [21]. This ''drift'' phenomenon is similar to what has been described for metal-on-metal hip implants, which have long received clearance through the 510(k) pathway [1,9].…”

Section: Introductionmentioning

confidence: 88%

“…In the only other analysis of PMA supplement-approved postmarket device changes, Rome et al [21] reported a median of 50 device changes per cardiac implantable electronic device, or 2.6 changes per device-year-more than observed for orthopaedic devices. These differences may reflect the high rate of software modifications that may occur during the lifespan of a cardiac implantable electronic device.…”

Section: Orthopaedic Devices Receiving Pma Approvalmentioning

confidence: 96%

“…Even in other fields, the 510(k) premarket notification process historically has been the most widely used pathway to market for high-risk devices. Rome et al [21] reported on 77 original PMA approvals for cardiac implantable electronic devices between 1979 and 2012. Garber [9] reported that from 2003 to 2007, a total of 228 Class III devices were cleared for marketing via the 510(k) process versus 170 device receiving PMA-approval.…”

Section: Orthopaedic Devices Receiving Pma Approvalmentioning

confidence: 99%

“…The most commonly used supplement review track since the start of the program has been the 180-day track (36%), intended for significant device modifications [27], while the 30-day notice and 135-day review, intended for minor manufacturing process changes, have become more common. For cardiac implantable electronic devices, the most commonly used supplement review track since the start of the PMA program has been the 30-day notice (47%) [21]. With the introduction of new supplement review tracks, corresponding increases in the total rates of supplements cleared also has been observed.…”

Section: Pma Supplement Review Tracksmentioning

confidence: 99%

“…Furthermore, a large percentage of changes in device indications (46.2%), were approved via real-time and 180-day tracks, despite that the changes in indication are intended to undergo formal panel track approval, which requires submission of new clinical data. For cardiac implantable electronic devices, the majority of real-time and 180-day track supplements were used for changes in device design or components (76%) [21], whereas for orthopaedic devices, design and component changes accounted for only 41% of all 180-day track and real-time supplements. While the FDA has ultimate control over which supplement review tracks are used for device changes, there is potential for overuse of certain review tracks to expedite time to approval.…”

Section: Types Of Postmarket Device Changesmentioning

confidence: 99%

See 4 more Smart Citations

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel

Rathi

Grauer

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. Questions/purposes We asked: What are (1) the types of original orthopaedic devices receiving FDA PMA approval, (2) the number and rate of postmarket device changes approved per device, (3) the types of PMA supplement review tracks used, (4) the types of device changes approved via the various review tracks, and (5) the number of device recalls and market withdrawals that have occurred for these devices? Methods All original PMA-approved orthopaedic devices between January 1982 and December 2014 were identified in the publically available FDA PMA database. The number of postmarket device changes approved, the PMA supplement review track used, the types of postmarket changes, and any FDA recalls for each device were assessed. Results Seventy original orthopaedic devices were approved via the FDA PMA pathway between 1982 and

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Section: Introductionmentioning

confidence: 88%

Section: Orthopaedic Devices Receiving Pma Approvalmentioning

confidence: 96%

Section: Orthopaedic Devices Receiving Pma Approvalmentioning

confidence: 99%

Section: Pma Supplement Review Tracksmentioning

confidence: 99%

Section: Types Of Postmarket Device Changesmentioning

confidence: 99%

See 3 more Smart Citations

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel

Rathi

Grauer

et al. 2016

Clinical Orthopaedics &Amp; Related Research

View full text Add to dashboard Cite

show abstract

Opening the FDA Black Box

Goodman

Redberg

2014

JAMA

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Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

Rathi

Krumholz

Masoudi

et al. 2015

JAMA

114

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Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.OBJECTIVE To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. DESIGN AND SETTINGAll clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. MAIN OUTCOMES AND MEASURESStudies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. RESULTSIn 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer/investigator-initiated postmarket studies, respectively. Approximately half of all studies used no comparator (pivotal: 13/30 [43.3%]; completed postmarket: 16/26 [61.5%]; ongoing postmarket: 70/153 [45.8%]). Median duration of primary effectiveness end point follow-up was 3.0 months (IQR, 3.0-12.0), 9.0 months (IQR, 0.3-12.0), and 12.0 months (IQR, 7.0-24.0) for pivotal, completed postmarket, and ongoing postmarket studies, respectively.CONCLUSIONS AND RELEVANCE Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval.

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FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Cited by 61 publications

References 10 publications

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Opening the FDA Black Box

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

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