Premarket Approval Supplement Pathway: Do We Know What We Are Getting?

Zheng, Sarah; Redberg, Rita F.

doi:10.7326/m13-2931

Cited by 14 publications

(25 citation statements)

References 4 publications

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“…24 Given the significant clinical implications of device failure, 29 otolaryngologists should understand that new device models are generally marketed without supporting clinical evidence, and the accumulation of incremental changes over time may lead devices used in practice to differ substantially from those originally described in published studies. 9 Expansion of current FDA outreach efforts through social media and other consumer-facing websites (eg, Wikipedia) could help keep otolaryngologists and their patients digitally updated on clinically significant device changes. 30 In addition, increased regulatory transparency may help otolaryngologists more accurately assess the risks and benefits of new device models.…”

Section: Discussionmentioning

confidence: 99%

Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration

Rathi

Ross

Samuel

et al. 2015

Otolaryngol.--head neck surg.

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Section: Discussionmentioning

confidence: 99%

Postmarket Modifications of High‐Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration

Rathi

Ross

Samuel

et al. 2015

Otolaryngol.--head neck surg.

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“…Several studies have shown poor performance of various newly released orthopaedic devices without supporting premarket clinical data [7,14,16]. In addition, remarketing of new devices based on changes implemented via PMA supplements may permit devices that may be used for substantially different purposes than supported by original clinical evidence [34]. As a result, continued postmarket surveillance of high-risk orthopaedic devices is critical to ensure patient safety [5].…”

Section: Device Recalls and Market Withdrawalmentioning

confidence: 99%

“…Despite the evidentiary requirements of the PMA pathway, there has been concern that the clinical studies forming the basis of PMA applications may lack adequate strength and be prone to bias [3,5,6,12,13,20,34]. This is especially worrisome for implantable devices that cannot be easily removed or discontinued.…”

Section: Introductionmentioning

confidence: 99%

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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“…75 At what point multiple device modifications may change the underlying safety or effectiveness profile and require clinical testing is unknown but deserves further consideration. 76 …”

Section: Additional Features Of the Medical Device Approval Processmentioning

confidence: 99%