Spinal devices in the United States—investigational device exemption trials and premarket approval of class III devices

2017 ◽  
Vol 17 (1) ◽  
pp. 150-157 ◽  
Author(s):  
S. Raymond Golish ◽  
Michael L. Reed
Keyword(s):  
United States ◽  
The United States ◽  
Class Iii ◽  
Investigational Device Exemption ◽  
Premarket Approval

Regulatory Assessment of Premarket Approval of Medical Devices in US and EU

2017 ◽  
Vol 9 (04) ◽  
Author(s):  
M.P. Venkatesh ◽  
Divya Bandla
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States ◽  
The European Union ◽  
Class Iii ◽  
Risk Class ◽  
Class Iib ◽  
Set Up ◽  
Premarket Approval

The demand for medical devices globally has raised the attention of government regulatory bodies to ensure the safety and effectiveness of these products. Developed markets, such as the United States and European Union, have set up wellestablished regulatory systems for medical devices, which have consistently been amended to accommodate the changing requirements of safety and the trend of globalization. The way in which devices are regulated in the European Union is very different from that of United States, especially in terms of the clinical data required for premarket approval. This has introduced significant differences in time-to-market approval for both United States and European Union, particularly in the case of high-risk Class III and Class IIb implantable devices. Systems for approving new medical devices must provide pathways to market important innovations besides ensuring that patients are adequately protected. To achieve these goals, the United States and the European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes which will benefit device manufacturers to develop devices which can be marketed both in US and EU simultaneously

scholarly journals Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Sravya B. Shankara ◽  
Yujia Liu ◽  
Qingfeng Zheng ◽  
Jing Guo ◽  
Guixia Wang ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Data Analysis ◽  
Statistical Analysis ◽  
Study Design ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
The United States ◽  
Closed Loop System ◽  
Premarket Approval

Objective. The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational artificial pancreas device systems (APDSs) in premarket approval applications. Methods. The United States Food and Drug Administration (FDA) guidance on the content of investigational device exemption and premarket approval applications for APDSs is reviewed with special emphasis on study design and statistical analysis of the pivotal clinical trials. The two pivotal studies for the MiniMed 670G hybrid closed-loop system by Medtronic in their premarket approval application are summarized and discussed. Results. The United States FDA established detailed recommendations on the study design and statistical analysis of pivotal clinical trials for the industry that seek market investigational APDSs and for FDA scientific reviewers that regulate the device applications. The recommendations cover specifics regarding patient population, clinical endpoints, and strategies for data analysis. However, the two pivotal studies that demonstrated the effectiveness of the FDA-approved MiniMed 670G hybrid closed-loop system were not typical randomized controlled trials as per FDA recommendations. Conclusion. The development and regulation of investigational APDSs require careful and sophisticated clinical study designs and data analysis in premarket approval applications. The regulatory evaluation process of the APDSs is rather complicated since the devices consist of multiple components that collaboratively function to mimic human pancreases.

scholarly journals Navigating the Regulatory Pathways and Requirements for Tissue-Engineered Products in the Treatment of Burns in the United States

2020 ◽  
Author(s):  
Kimberly Belsky ◽  
Janice Smiell
Keyword(s):  
United States ◽  
The United States ◽  
Biologically Active ◽  
Class Iii ◽  
Skin Substitutes ◽  
Burn Treatment ◽  
Regulatory Pathways ◽  
Biologics License Application ◽  
License Application ◽  
Promotional Materials

Abstract In the burn treatment landscape, a variety of skin substitutes, human tissue-sourced products, and other products are being developed based on tissue engineering (ie, the combination of scaffolds, cells, and biologically active molecules into functional tissue with the goal of restoring, maintaining, or improving damaged tissue or whole organs) to provide dermal replacement, prevent infection, and prevent or mitigate scarring. Skin substitutes can have a variety of compositions (cellular vs acellular), origins (human, animal, or synthetically derived), and complexities (dermal or epidermal only vs composite).The regulation of tissue-engineered products in the United States occurs by one of several pathways established by the US Food and Drug Administration, including a Biologics License Application, a 510(k) (Class I and Class II devices), Premarket Approval (Class III devices), or a human cells, tissues, and cellular and tissue-based products designation. Key differentiators among these regulatory classifications include the amount and type of data required to support filing. For example, a Biologics License Application requires a clinical trial(s) and evaluation of safety and efficacy by the Center for Biologics Evaluation and Research. Applicable approved biologic products must also comply with submission of advertising and promotional materials per regulations.This review provides a description of, and associated requirements for, the various regulatory pathways for the approval or clearance of tissue-engineered products. Some of the regulatory challenges for commercialization of such products for the treatment of burns will be explored.

Pinellas County Resource Recovery Facility Capital Replacement Project: One Year of Improved MSW Throughput and Electrical Generation

2005 ◽  
Author(s):  
Thomas M. White ◽  
Donald J. Castro ◽  
Robert Hauser
Keyword(s):  
United States ◽  
Resource Recovery ◽  
The United States ◽  
Waste To Energy ◽  
Class Iii ◽  
Pinellas County ◽  
Energy Plant ◽  
One Year ◽  
Electrical Generation ◽  
Capital Replacement

In May of 2003, the 3,150 TPD Pinellas County Resource Recovery Facility (PCRRF), the largest waste-to-energy plant in the United States, reached its 20-year milestone. The PCRRF is located in St. Petersburg, Florida, on a 705 acre (1.1 square mile) site owned by Pinellas County and known as “Bridgeway Acres”. The PCRRF has been owned by Pinellas County, operated by Wheelabrator Pinellas, Inc. (WPI) and monitored by HDR Engineering, Inc. since its inception. In addition to the PCRRF, the County operates both Class I and Class III landfills on the site.

scholarly journals The Effect of Social Determinants and Socioeconomic Status on Laparoscopic Roux-En-Y Gastric Bypass for Weight Loss: An Analysis of the National Inpatient Sample

2021 ◽  
Vol 07 (03) ◽  
pp. e147-e153
Author(s):  
Supreet Singh ◽  
Jarot J. Guerra ◽  
Paige Lazar ◽  
Aziz M. Merchant
Keyword(s):  
United States ◽  
Gastric Bypass ◽  
Severe Obesity ◽  
The United States ◽  
Class Ii ◽  
Class Iii ◽  
National Inpatient Sample ◽  
Black Patients ◽  
Class Iii Obesity ◽  
Postoperative Intestinal Obstruction

Abstract Objective In the United States, Black and Hispanic patients have a higher prevalence of obesity than Whites (49.6 vs. 44.8 vs. 42.2%, respectively). Despite higher rates of obesity among minority populations, bariatric surgery is performed at higher obesity levels in minorities than in Whites. This study examines the effects of various socioeconomic factors such as race, payer type, and income on the likelihood of undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) at class II versus class III obesity and their associated complications. Materials and Methods National Inpatient Sample (NIS) from 2016 to 2017 was queried to identify patients at least 18 years of age with a concomitant diagnosis of class II or class III obesity who underwent LRYGB. We analyzed obesity level at the time of LRYGB (class II vs. class III), postoperative intestinal obstruction during the admission, and occurrence of any noninfectious complication related to the surgery as our main outcomes. A multivariate logistic regression model was utilized to assess the association between our outcomes and socioeconomic factors associated with the admission. Results A total of 76,405 LRYGB operations were included. Out of this total, 83% (63,640) LRYGB operations were in class III obesity. Black patients had a lower rate (11.6%) of LRYGB procedures at class II obesity than White (17.6%) and Hispanic (18%) patients (p < 0.001). Medicare, Medicaid, and lower income quartiles also showed lower rates of operation at class II obesity (p < 0.001). Black patients were 29% (95% confidence interval [CI]: 0.61–0.83, p < 0.001) less likely than Whites to have a LRYGB procedure at class II obesity, they were 119% (95% CI: 1.17–4.11, p = 0.0014) more likely to suffer a postoperative intestinal obstruction, and they were 93% (95% CI: 1.31–2.84, p < 0.001) more likely to suffer a noninfectious complication. Conclusion Socioeconomic disparities in the surgical management of severe obesity persist in the United States, especially for LRYGB. This study highlights multiple demographic factors that led to LRYGB at later obesity levels. Black patients were also more likely to be associated with postoperative complications during the admission. The determinants of health disparities in obese patients need to be examined further to reduce potential long-term morbidity and mortality in minorities. Further research is also required to identify the adverse effects of health disparities in patients with severe obesity and obesity-related comorbidities.

scholarly journals Culture-Independent Metagenomic Surveillance of Commercially Available Probiotics with High-Throughput Next-Generation Sequencing

mSphere ◽  
2016 ◽  
Vol 1 (2) ◽  
Author(s):  
Jennifer N. Patro ◽  
Padmini Ramachandran ◽  
Tammy Barnaba ◽  
Mark K. Mammel ◽  
Jada L. Lewis ◽  
...  
Keyword(s):  
United States ◽  
Next Generation Sequencing ◽  
The United States ◽  
Analytical Tool ◽  
Next Generation ◽  
Culture Methods ◽  
Next Generation Sequencing Technology ◽  
Culture Independent ◽  
Premarket Approval ◽  
Generation Sequencing

ABSTRACT The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Millions of people consume dietary supplements either following a doctor’s recommendation or at their own discretion to improve their overall health and well-being. This is a rapidly growing trend, with an associated and expanding manufacturing industry to meet the demand for new health-related products. In this study, we examined the contents and microbial viability of several popular probiotic products on the United States market. Culture-independent methods are proving ideal for fast and efficient analysis of foodborne pathogens and their associated microbial communities but may also be relevant for analyzing probiotics containing mixed microbial constituents. These products were subjected to next-generation whole-genome sequencing and analyzed by a custom in-house-developed k-mer counting method to validate manufacturer label information. In addition, the batch variability of respective products was examined to determine if any changes in their formulations and/or the manufacturing process occurred. Overall, the products we tested adhered to the ingredient claims and lot-to-lot differences were minimal. However, there were a few discrepancies in the naming of closely related Lactobacillus and Bifidobacterium species, whereas one product contained an apparent Enterococcus contaminant in two of its three lots. With the microbial contents of the products identified, we used traditional PCR and colony counting methods to comparatively assess our results and verify the viability of the microbes in these products with regard to the labeling claims. Of all the supplements examined, only one was found to be inaccurate in viability. Our use of next-generation sequencing as an analytical tool clearly demonstrated its utility for quickly analyzing commercially available products containing multiple microbes to ensure consumer safety. IMPORTANCE The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Podcast: A podcast concerning this article is available.

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