Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

Ghobadi, Comeron W.; Hayman, Emily; Finkle, Joshua H.; Walter, Jessica; Xu, Shuai

doi:10.1016/j.jacr.2016.08.014

Cited by 7 publications

(4 citation statements)

References 19 publications

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“…Of 213 end points, 187 (88%) were surrogate measures, such as target lesion revascularization for a coronary stent and lead implant success for an electrophysiology device, which are believed likely to correlate with clinical outcomes. Studies in other therapeutic areas have found similar weaknesses in trial design . By contrast, in applications for medication approvals from 2005 to 2012, a comparable study of 448 pivotal trials of 188 drugs for 201 indications found that 400 (89% of 448) were randomized, 356 (80%) were double-blind, and 219 (49%) were based on surrogate measures .…”

Section: Resultsmentioning

confidence: 99%

“…Studies in other therapeutic areas have found similar weaknesses in trial design. [80][81][82][83][84] By contrast, in applications for medication approvals from 2005 to 2012, a comparable study of 448 pivotal trials of 188 drugs for 201 indications found that 400 (89% of 448) were randomized, 356 (80%) were double-blind, and 219 (49%) were based on surrogate measures. 85 Of the 201 approved indications, 74 (37%) were based on a single pivotal trial.…”

Section: Evidence Supporting New Devicesmentioning

confidence: 99%

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FDA Regulation and Approval of Medical Devices: 1976-2020

Darrow

Avorn

Kesselheim

2021

JAMA

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edical devices occupy a prominent position in health care and among health-related products. According to reports from 2017 and 2018, more than 18 000 manufacturers produce an estimated 190 000 distinct medical devices that are regulated by the US Food and Drug Administration (FDA). 1,2 Spending on medical devices in the US was estimated at $173 billion in 2019, 3 an increase from an estimated $36 billion (in 2019 dollars) in 1983. 4 The medical device industry is regulated primarily under a framework established by the Medical Device Amendments of 1976 5 to the Food, Drug, and Cosmetic Act of 1938. 6 Because of rapid technological advances over the subsequent 4 decades, the US Congress and FDA modified regulatory standards to minimize unnecessary requirements, promote the availability of innovative devices, adapt to entirely new technologies such as digital mobile apps, and fulfill the agency's mission as a steward of the public's health (Box 1). The COVID-19 pandemic has contributed to a renewed focus on the assessment of medical devices and tests, an area of regulation that previously received limited attention.This Special Communication describes the evolution of laws and standards that have shaped the testing of medical devices, the pathways that exist for FDA authorization, changes in the role and authority of the FDA, trends in the number of devices approved from 1976 to 2020, and the implications for patient care and outcomes.IMPORTANCE US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.OBJECTIVE To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020.EVIDENCE REVIEW Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry.FINDINGS Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 201...

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Section: Resultsmentioning

confidence: 99%

Section: Evidence Supporting New Devicesmentioning

confidence: 99%

FDA Regulation and Approval of Medical Devices: 1976-2020

Darrow

Avorn

Kesselheim

2021

JAMA

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“…The manufacturer (Bayer) has voluntarily halted sales of Essure as of 2018. Indeed, across multiple specialties, high-risk devices are often approved based on clinical data that lack power or comparator arms, or have short follow-up times [12][13][14][15]. Ultimately, there is no replacement for rigorous, well-designed clinical studies with well-validated primary clinical endpoints to ensure device safety and efficacy.…”

Section: Preapproval Requirements For Medical Devices Still Fall Shortmentioning

confidence: 99%

Reducing FDA regulations for medical devices: cutting red tape or putting patients’ lives at risk?

Janetos

Walter

et al. 2018

Expert Review of Medical Devices

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“…25,27 Discussion Most premarket data leading to the approval of STFs is based on splitface, masked RCTs. As class III devices, STFs are more likely to be approved based on RCTs relative to previous reports 13, [31][32][33][34][35] on highrisk (class III) medical devices in cardiology, ophthalmology, gastroenterology, radiology, and obstetrics and gynecology. Another strength of the premarket pivotal studies was the use of validated scales to assess product efficacy (Box).…”

Section: Key Pointsmentioning

confidence: 99%

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

Lohman

Ghobadi

2017

JAMA Facial Plast Surg

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oft-tissue filler (STF) injections are the second most common nonsurgical cosmetic procedure in the United States, preceded only by botulinum toxin injections. In 2015, the number of STF procedures increased more than 27% for hyaluronic acid, 15% for calcium hydroxylapatite (Radiesse), and 4% for poly-L-lactic acid (Sculptra) injections from the prior year. 1 Absorbable STFs are approved for correction of facial wrinkles and skin folds, such as the nasolabial folds. A permanent STF is indicated for nasolabial folds and acne scars, whereas the indications for other permanent STFs are limited to correction of lipoatrophy in individuals with human immunodeficiency virus (HIV). 2 However, off-label use of STFs for upper, middle, and lower facial treatments is common in women and increasing in men. [3][4][5][6] Soft-tissue fillers are regulated as a class III medical device, the highest risk designation given by the FDA. Most class III devices require a premarket approval (PMA) application detailing the device's safety and efficacy. 7 In May 2015, the FDA issued a safety communication that highlighted reported complications of STFs, including vision impairment, blindness, stroke, and death of skin and facial structures. 8 In aesthetic medicine, there has been ongoing concern about the safety of STFs and the risk of irreversible adverse events (AEs). Because of the popularity of STFs, recent safety concerns, and legislative changes to medical device regulation, including the recent passage of the 21st Century Cures Act, [9][10][11] there is an impetus for clinicians to understand the quality of evidence that led to approval of STFs and the implications for future device safety. MethodsThe FDA's publicly available database of original PMAs was assessed for all STFs using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The FDA publishes a summary of safety and effectiveness data (SSED) for approved devices that details the preclinical, pivotal, and supplemental trials from the PMA process. This document is the primary source of PMA data provided by the FDA. The manufacturer typically prepares the SSED with guidelines provided by the FDA. Of 14 original IMPORTANCE The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis.OBJECTIVE To examine the quality of evidence leading to FDA approval of STFs.EVIDENCE REVIEW All original approvals for STFs were mined using the publicly available FDA database. The Cochrane Collaboration's risk of bias assessment tool was applied to all randomized clinical trials (RCTs).FINDINGS A total of 14 STF approvals were identified. Of those, 10 pivotal studies (71%) were RCTs and 9 (60%) were masked. The median number of patients per trial was 144 (range, 30-439). Eleven of 12 studies (92%) met their primary end point. Ten of 14 trials (71%) involved injections solely of the nasolabial folds or cheeks; only 4 trials involved treatment of other facial r...

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Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

Cited by 7 publications

References 19 publications

FDA Regulation and Approval of Medical Devices: 1976-2020

FDA Regulation and Approval of Medical Devices: 1976-2020

Reducing FDA regulations for medical devices: cutting red tape or putting patients’ lives at risk?

Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers

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