Report: FDA plans reorganized “ super office ” for device regulation

The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report. The new office will aim to support a new dynamic and overcome existing separations of functionality within the FDA to create “more organic connections and information sharing,” CDRH head Jeffrey Shuren said, according to the report. The change comes as the federal watchdog looks to shift its monitoring to taking into account the total product lifecycle of medical devices, RAPS reports, and will fold four previously separate offices into a single entity. “We’re taking technologies that we put into different offices and move away from a branch structure to instead have teams focused on a specific set of technologies,” Shuren said, according to the report. Technologies will be separated into six separate departments, with each focusing on a set of devices. Ophthalmic, anesthetic, respiratory, ENT and dental devices will make up the first division, cardiovascular devices will make up the second, and reproductive, gastro-renal, urological, general hospital devices and human factors will make up the third. The fourth division will focus on surgical and infection control devices, the fifth on neurological and physical medicine devices and the last will focus entirely on orthopedic devices, according to the repo...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Center for Devices and Radiological Health (CDRH) Source Type: news

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Publication date: Available online 21 July 2018Source: Physiology &BehaviorAuthor(s): Hu Hong-qiang, Shu Mang-qiao, Xue Fen, Liu Shan-shan, Cao Hui-juan, Hou Wu-gang, Yan Wen-jun, Peng Zheng-wuAbstractHyperbaric oxygen (HBO) preconditioning (PC) has been suggested as a feasible method to provide neuroprotection from postoperative cognitive dysfunction (POCD). However, whether HBO-PC can ameliorate cognitive deficits induced by isoflurane, and the possible mechanism by which it may exert its effect, has not yet been clarified. In the present study, middle-aged mice were exposed to isoflurane anesthesia (1.5 minimal alve...
Source: Physiology and Behavior - Category: Physiology Source Type: research
ConclusionThe AEGEA Vapor System is a safe effective and minimally invasive option for performing in-office endometrial ablation. under minimal anesthesia for the purpose of treating women who suffer from HMB.
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
ConclusionsSBES is safe and effective, with minimal morbidity. SBES has the potential advantages of shorter operative time, reduced anesthesia, and reduced hospital time, which can benefit patients, surgeons, and health care systems.Patient summarySimultaneous bilateral endoscopic surgery is an effective treatment with low complication rates for bilateral urolithiasis. This innovative and complicated procedure should be performed in high-volume centers by experienced surgeons.
Source: European Urology - Category: Urology & Nephrology Source Type: research
This study aimed to evaluate the effects of sevoflurane on working memory of rats and to characterize functional connectivity between excitatory neurons in the prefrontal cortex (PFC) during working memory performance.Methods18-month-old and 3-month-old male SD rats were implanted with a multielectrode array in the PFC. After recovery from the surgery, the aged and adult rats were divided into sevoflurane group and control group, respectively. Rats in sevoflurane group were exposed to 1 minimum alveolar concentration (MAC) or 1.5 MAC sevoflurane for two hours. At day1, 3, and 7 after exposure, the effects of sevoflurane an...
Source: Biomedicine and Pharmacotherapy - Category: Drugs & Pharmacology Source Type: research
Publication date: Available online 20 July 2018Source: Trends in Anaesthesia and Critical CareAuthor(s): Richard Christie, Alex Kennedyh
Source: Trends in Anaesthesia and Critical Care - Category: Anesthesiology Source Type: research
Publication date: Available online 20 July 2018Source: Brazilian Journal of Anesthesiology (English Edition)Author(s): Bruno Mendes Carmona, Clauber Claudino Alves Almeida, Waldônio de Brito Vieira, Mario de Nazareth Chaves Fascio, Lídia Raquel de Carvalho, Luiz Antonio Vane, Fabiano Timbó Barbosa, do Nascimento Junior Paulo, Norma Sueli Pinheiro MódoloAbstractBackgroundAdequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. We proposed to study the sonographic gastric content dynamics after the ingestion of liquid or solid food in healthy volunteers and c...
Source: Brazilian Journal of Anesthesiology - Category: Anesthesiology Source Type: research
Source: Journal of Anesthesia - Category: Anesthesiology Source Type: research
ConclusionsImplementation of a multifaceted intervention improved rates of guideline-concordant redosing of intraoperative prophylactic antibiotics.Graphical abstract
Source: American Journal of Infection Control - Category: Infectious Diseases Source Type: research
CONCLUSION: This small study showed that visual distraction should be considered as a simple and cost-effective alternative to local anaesthetic for flexible laryngoscopy. PMID: 30022747 [PubMed - as supplied by publisher]
Source: Journal of Laryngology and Otology - Category: ENT & OMF Tags: J Laryngol Otol Source Type: research
CONCLUSIONS: Propofol inhibits viability and induces apoptosis of A549 cells via an ERK1/2-dependent PUMA signaling. PMID: 30024623 [PubMed - in process]
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
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