Demystifying the U.S. Food and Drug Administration

Naghshineh, Nima; Brown, Spencer J.; Cederna, Paul S.; Lévi, Benjamin; Lisiecki, Jeffrey; D’Amico, Robert; Hume, Keith M.; Seward, William Henry; Rubin, Jennifer

doi:10.1097/prs.0000000000000477

Cited by 29 publications

(12 citation statements)

References 11 publications

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“…Our finding that total psoas area predicted mortality in oropharyngeal cancer patients on univariate analysis is not surprising given total psoas area decline is associated with increased mortality in multiple clinical settings (Zarinsefat et al 2014 ; Levi et al 2014 ; Waits et al 2014 ; Englesbe et al 2013 ; Sheetz et al 2013 ; Miller et al 2012 ; Sabel et al 2011 ). It is surprising that decline in psoas area independently predicted tumor recurrence adjusted for age, T-stage, and weight loss.…”

Section: Discussionmentioning

confidence: 72%

“…Body morphomics analysis can rapidly and accurately characterize the changes in regional body composition in cancer patients, and has shown a strong correlation between trunk muscle (psoas) size and mortality in multiple clinical settings, including postoperatively following liver transplant surgery, abdominal aneurysm surgery, and inpatient general surgery (Zarinsefat et al 2014 ; Levi et al 2014 ; Waits et al 2014 ; Englesbe et al 2013 ; Sheetz et al 2013 ). Core muscle size has similarly shown prognostic value in patients with esophageal cancer (Sheetz et al 2013 ), adrenocortical carcinoma (Miller et al 2012 ), and melanoma (Sabel et al 2011 ).…”

Section: Introductionmentioning

confidence: 99%

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Investigating the clinical significance of body composition changes in patients undergoing chemoradiation for oropharyngeal cancer using analytic morphomics

et al. 2016

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BackgroundThe purpose is to investigate the clinical significance of body morphomics changes in stage III–IV oropharyngeal cancer patients during concurrent chemoradiotherapy (CRT).MethodsFifty patients who underwent CRT were selected for body composition analyses by either availability of pre/post treatment DEXA scans or a novel CT-based approach of body morphomics analysis (BMA). BMA changes (lean psoas and total psoas area) were compared to total lean body mass changes by DEXA scans using two-sample t tests. Pearson correlation was used to compare the BMA measures to head and neck specific quality of life outcomes. Cox hazards model was used to predict mortality and tumor recurrence.ResultsClinically significant declines in total psoas area and lean body mass of similar magnitude were observed in both BMA and DEXA cohorts after CRT. Loss of psoas area (P < 0.05) was associated with greater frailty and mobility issues (3 out of 15 UWQOL domains). Total psoas area is more sensitive for local recurrence than weight changes and T-stage on multivariate analyses.ConclusionsBMA specifically evaluating psoas area appears to correlate with head and neck cancer quality of life physical domains. Pre- and post-treatment total psoas area at L4 appears prognostic for tumor recurrence.

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Section: Discussionmentioning

confidence: 72%

Section: Introductionmentioning

confidence: 99%

Investigating the clinical significance of body composition changes in patients undergoing chemoradiation for oropharyngeal cancer using analytic morphomics

et al. 2016

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“…The 510(k) process allows a company to fast-track approval of a device by claiming it “substantially equivalent” to a device that has already been approved and marketed. Claiming that one device is equivalent to another device may be illogical even when the predicate comes from the same company [ 17 - 18 ]. This process may also lead to devices being approved on the predicate from another device that was itself approved through the 510(k) process, sometimes leading to decades between the original device and subsequent predicate devices without an increase in evidence of the product working [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration

Pellerin

Panchbhavi

Janney

2018

Cureus

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IntroductionOrthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years.MethodsThe Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 2007 through 2017 for the manufacturer, process of approval, type of implant, recall class, dates of initiation and termination of the recall, manufacturer determined reason, quantity affected, and distribution within the United States or internationally.ResultsA total of 161 products from 33 companies were identified with 158 (98.1%) approved through the 510(k) process. The most common reason for device recall was due to the device breaking intraoperatively or postoperatively. The average length of the recall was 487.5 days. ConclusionsDevice recall is not an uncommon event with the majority of products approved through the less demanding 510(k) process.

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“…Furthermore, quantifying patient frailty has been shown to be useful in predicting outcome in patients with adrenocortical carcinoma by focusing on the psoas muscle and intra-abdominal fat characteristics [25]. Morphologic variations among patients have also been shown to predict liver transplant morbidity, surgical site infection, and length of stay and mortality in patients undergoing general and vascular surgery [26–28]. This method of morphomic analysis confers several advantages including the inter-institutional reproducibility of CT imaging, the ability to objectively assess these scans using programmed software, and the real-time nature of this data.…”

Section: Discussionmentioning

confidence: 99%

Morphomic analysis as an aid for preoperative risk stratification in patients undergoing major head and neck cancer surgery

Rinkinen

Agarwal

Beauregard

et al. 2015

Journal of Surgical Research

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Background Patients undergoing major head and neck cancer surgery (MHNCS) may develop significant postoperative complications. To minimize the risk of complications, clinicians often assess multiple measures of preoperative health in terms of medical comorbidities. One emerging method to decrease surgical complications is preoperative assessment of patient frailty measured by specific tissue characteristics. We hypothesize that morphomic characteristics of the temporalis region serve as predictive markers for the development of complications after MHNCS. Methods We performed a retrospective review of 69 patients with available computed tomography (CT) imaging who underwent MHNCS from 2006–2012. To measure temporalis region characteristics, we used morphomic analysis of available preoperative CT scans to map out the region. All available CT scans had been performed as part of the patient’s routine work-up and were not ordered for morphomic analysis. We describe the correlation among temporalis fat pad volume (TFPV), mean zygomatic arch thickness, and incidence of postoperative complications. Results We noted significant difference in the zygomatic bone thickness and TFPV between patients who had medical complications, surgical complications, or total major complications and those who did not. Furthermore, by use of binary logistic regression, our data suggest decreased TFPV and zygomatic arch thickness are stronger predictors of developing postoperative complications than previously studies preoperative characteristics. Conclusions We describe morphomic analysis of the temporalis region in patients undergoing MHNCS to identify patients at risk for complications. Regional anatomic morphology may serve as a marker to objectively determine a patient’s overall health. Use of the temporalis region is appropriate in patients undergoing MHNCS because of the availability of preoperative scans as part of routine work up for head and/or neck cancer.

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Demystifying the U.S. Food and Drug Administration

Abstract: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

Cited by 29 publications

References 11 publications

Investigating the clinical significance of body composition changes in patients undergoing chemoradiation for oropharyngeal cancer using analytic morphomics

Investigating the clinical significance of body composition changes in patients undergoing chemoradiation for oropharyngeal cancer using analytic morphomics

An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration

Morphomic analysis as an aid for preoperative risk stratification in patients undergoing major head and neck cancer surgery

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