Abstract：
:An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.
journal_name
Semin Pediatr Surgjournal_title
Seminars in pediatric surgeryauthors
Connor JAdoi
10.1053/j.sempedsurg.2006.07.009subject
Has Abstractpub_date
2006-11-01 00:00:00pages
293-301issue
4eissn
1055-8586issn
1532-9453pii
S1055-8586(06)00057-6journal_volume
15pub_type
杂志文章,评审abstract：:Myelomeningocele (MMC) is a common birth defect that is associated with significant lifelong morbidity. Little progress has been made in the postnatal surgical management of the child with spina bifida. Postnatal surgery is aimed at covering the exposed spinal cord, preventing infection, and treating hydrocephalus wit...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1016/s1055-8586(03)00029-5
更新日期：2003-08-01 00:00:00
abstract：:The care provided in the postanesthesia recovery unit has become much more sophisticated in recent years. We address what type of care should be provided and what equipment is required to provide such care in the present day pediatric postanesthesia care unit. In this regard a wide variety of potential postanesthetic ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：
更新日期：1992-02-01 00:00:00
abstract：:Congenital obstructive uropathy is a relatively common developmental malformation, and severely affected fetuses die soon after birth from oligohydramnios-induced pulmonary hypoplasia or renal failure. Prenatal ultrasonography can reliably diagnose the specific anatomic defect, and using fetal urine sampling we can de...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：
更新日期：1993-05-01 00:00:00
abstract：:This paper aims to provide an overview of islet cell transplantation in children, with specific attention to pediatric total pancreatectomy with islet autotransplantation (TPIAT). We will summarize the definition and causes of chronic pancreatitis in children, the TPIAT procedure and potential complications, the proce...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1016/j.sempedsurg.2020.150925
更新日期：2020-06-01 00:00:00
abstract：:Increased portal pressure is the product of both increased resistance to splanchnic flow through the liver and increased blood flow in the portal circuit. Although portal hypertension in children is less common than in adults, the important clinical end results are the same, ie, esophageal variceal hemorrhage, ascites...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：
更新日期：1992-05-01 00:00:00
abstract：:The incidence and prevalence of childhood-onset inflammatory bowel diseases (IBD), including subtypes Crohn's disease and ulcerative colitis, have risen dramatically in recent years, and have emerged globally as important pediatric chronic diseases. Therefore, health care providers are more frequently encountering ver...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2017.10.010
更新日期：2017-12-01 00:00:00
abstract：:Until the 1970s, bladder exstrophy was a frequently fatal birth defect that, at the very least, conferred a shortened life span with devastating consequences for afflicted patients. Beginning with the modern era of surgical management, survival has become routine, and now the focus is on optimizing a near-normal retur...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2011.01.001
更新日期：2011-05-01 00:00:00
abstract：:The unfavorable prognosis of congenital hyperinsulinism (CHI) can be avoided if the patients are treated with high-dose glucose infusions and timely surgical intervention. Circumscribed foci used to be identified by selective percutaneous pancreatic vein catheterization and determination of the insulin level. Fluorine...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1053/j.sempedsurg.2010.10.007
更新日期：2011-02-01 00:00:00
abstract：:This article discusses how to investigate various surgical causes of vomiting. Particular emphasis is placed on plain radiographic, ultrasound, and contrast study findings. The article touches upon nineteen different diseases, and encompasses diseases found in neonates to adolescents. ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2003.08.002
更新日期：2003-11-01 00:00:00
abstract：:Splenectomy in childhood usually is required for hematologic disorders such as hereditary spherocytosis, immune thrombocytopenic purpura, or sickle cell disease. The laparoscopic approach for splenectomy in children has been developed and advanced over the past 5 years. New techniques and equipment allow the procedure...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1016/s1055-8586(98)70032-0
更新日期：1998-11-01 00:00:00
abstract：:Management of pediatric intestinal failure has evolved in recent decades, with improved survival since the advent of specialized multidisciplinary intestinal failure centers. Though sepsis and intestinal failure associated liver disease still contribute to mortality, we now have growing data on the long-term outcomes ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2017.09.006
更新日期：2017-10-01 00:00:00
abstract：:Obesity affects 50% of adults and 18% of children in the USA. It has wide-ranging comorbidities with clinical, psychosocial, and economic ramifications. Obesity refers to a condition of excess body fat. The basis for weight gain is a fundamental imbalance between caloric intake and output, but individual variation bas...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1053/j.sempedsurg.2009.04.008
更新日期：2009-08-01 00:00:00
abstract：:Congenital tracheobronchial stenosis is a rare disease characterized by complete tracheal rings that can affect variable lengths of the tracheobronchial tree. It causes high levels of morbidity and mortality both due to the stenosis itself and to the high incidence of other associated congenital malformations. Success...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2016.02.007
更新日期：2016-06-01 00:00:00
abstract：:Selection of outcome determinants and risk stratification are necessary to identify patients at higher risk for morbidity and mortality. This facilitates human and material resource allocation and allows for improved family counseling. While several different factors, including prenatal ultrasonographic bowel features...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2018.08.007
更新日期：2018-10-01 00:00:00
abstract：:Caring for children with colorectal and pelvic reconstructive needs is complex and requires a lifelong commitment from clinicians devoted to the field. There has been a myriad of advances that have improved care and it has become clear that an integrated, multi-disciplinary approach maximizes the goal of improving the...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1016/j.sempedsurg.2020.150992
更新日期：2020-12-01 00:00:00
abstract：:Understanding the complex multisystem dysfunction in the infant with a congenital hernia of the posterolateral diaphragm is still evolving and has changed radically during the last decade. The reduction in lung mass, in conjunction with surfactant deficiency and diminished compliance, leads to initial deficiencies in ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：
更新日期：1996-11-01 00:00:00
abstract：:Developmental psychopathology is common in children with exstrophy. It may be mild or severe, and it may persist or transform as the child grows. The pediatric urologist is ideally situated to identify signs or symptoms of early developmental psychopathology in these children. Presented in this article are techniques ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2010.12.010
更新日期：2011-05-01 00:00:00
abstract：:Minimally invasive surgical approaches to various pediatric surgical disease processes are becoming the standard of care. Laparoscopic Nissen fundoplication is transitioning toward the preferred method for the surgical correction of gastroesophageal reflux (GER) disease in infants and children that do not respond to m...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/spsu.2002.35349
更新日期：2002-11-01 00:00:00
abstract：:The field of intestinal transplantation has experienced dramatic growth since the first reported cases 3 decades ago. Improvements in operative technique, donor assessment and immunosuppressive protocols have afforded children who suffer from life-threatening complications of intestinal failure a chance at long-term s...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2017.07.007
更新日期：2017-08-01 00:00:00
abstract：:A malignant tumor of striated muscle origin, rhabdomyosarcoma (RMS) is a childhood tumor that has benefited from nearly 30 years of multimodality therapy, culminating in a >70% overall 5-year survival. Prognosis for RMS is dependent on primary tumor site, age, completeness of resection, presence and number of metastat...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2016.09.011
更新日期：2016-10-01 00:00:00
abstract：:Adult and pediatric urologists, gynecologists, and surgeons are often faced with primary reconstruction of complex congenital defects of the vagina as seen in cloacal anomalies, disorders of sexual development (DSD), and vaginal agenesis as well as with the secondary repair of post-surgical or radiation-induced vagina...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1016/j.sempedsurg.2019.150843
更新日期：2019-10-01 00:00:00
abstract：:In dealing with conjoined twins, we have adopted a pragmatic approach in balancing what is possible, parental wishes and the likely outcome for the children. We believe that separation where feasible should be undertaken but appreciate that a few parents may wish their children to remain joined. The advice that we giv...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1053/j.sempedsurg.2015.06.008
更新日期：2015-10-01 00:00:00
abstract：:Pancreatic islet transplantation is a minimally invasive treatment that has the potential to prevent diabetes after total pancreatectomy for benign disease (islet autotransplantation) and to reverse diabetes in those with type 1 diabetes (islet allotransplantation). In both scenarios, the treatment involves extracting...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2012.05.012
更新日期：2012-08-01 00:00:00
abstract：:Children with anorectal malformations (ARMs) constitute a significant group within a pediatric surgery practice. In females, the most common ARM is an imperforate anus with a rectovestibular fistula, followed by an imperforate anus with a rectoperineal fistula and then cloacal anomalies. Some malformations, such as an...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1053/j.sempedsurg.2009.11.019
更新日期：2010-05-01 00:00:00
abstract：:Injuries to the solid abdominal viscera (spleen, liver, kidney, pancreas) are common in children sustaining trauma by blunt mechanisms. Success with nonoperative management of these injuries has led to recent extensions of this approach to the management of higher-grade more complicated injuries typically treated oper...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2004.01.006
更新日期：2004-05-01 00:00:00
abstract：:Variation in clinical practice patterns has attracted the attention of specialty organizations, payers, government health agencies, and the public. Such variation raises concerns about efficacy and cost relative to the care provided. Consequently, the establishment of national benchmarks has become an increasing prior...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章
doi：10.1053/j.sempedsurg.2008.02.006
更新日期：2008-05-01 00:00:00
abstract：:Identification of CDH infant populations at high risk for mortality postnatally may help to develop targeted care strategies, guide discussions surrounding palliation and contribute to standardizing reporting and benchmarking, so that care strategies at different centers can be compared. Clinical prediction rules are ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/j.sempedsurg.2017.04.010
更新日期：2017-06-01 00:00:00
abstract：:Neuroblastoma is a heterogenous disease, with solid tumors arising in the adrenal gland or paraspinal regions in young children. Neuroblastoma is unique, with varied presentation and prognosis based on primary location and tumor stage. Tumor behavior and response to treatment ranges from spontaneous regression to diss...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1016/j.sempedsurg.2019.150859
更新日期：2019-12-01 00:00:00
abstract：:Nutritional management of infants and children differs from that of adults because of the extra requirements for growth and the limitations of physiological immaturity. Although parenteral nutrition (PN) is an accepted practice and a potentially life-saving therapy for pediatric patients who cannot be fed through thei...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：
更新日期：1992-08-01 00:00:00
abstract：:The practice of pediatric surgery is at the crossroads of 2 specialties, pediatrics and surgery. At that vantage point, many ethical dilemmas can be seen. It is important for the pediatric surgeon to understand the special place of ethics in the care of children and how that care is influenced by society. The purpose ...
journal_title：Seminars in pediatric surgery
pub_type： 杂志文章,评审
doi：10.1053/spsu.2001.26837
更新日期：2001-11-01 00:00:00
