血管支架专业术语

FDA Medical DevicesCompiled by Yaw-Tsong LeeLast updated: 11 April 2009康涅狄格州纽黑文Currently, Dr. Joshua M. Sharfstein , is the acting commissioner of FDA CDRH = Center for Devices and Radiological Health器材与辐射保健中心CDER = Center For Drug Evaluation and Research药品评价和研究中心[top]1 A biofilm is a structured community of microorganisms encapsulated within a self-developed polymeric matrix and adherent to a living or inert surface2 A flat monthly fee that a health plan pays to a provider (doctor, hospital, lab, etc.) to take care of a patient's needs. Capitation is part of the provider-reimbursement mechanism3 (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety4 In epidemiology, a group of individuals with some characteristics in common5 A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.6 Prior to the FDA Modernization Act of 1997 (FDAMA), all devices on the market as of May 28, 1976 were classified according to their risk. Any new type of device that was found not substantially equivalent for a reason other than performance data required a Premakert Approval (PMA) application. A device could be moved out of Class III only through a reclassification process. The De Novo process provides a possible route to market low risk device types. This process does not apply to devices that have been classified by regulation into class III, i.e., preamendment class III devices or class III devices for which a premarket approval application or a reclassification petition is appropriate.FDAMA amended Section 513(f)(2) to provide a new mechanism for classifying new Class III devices for which there is no predicate device. The De Novo process is intended to apply to low risk products that have been classified as class III because they were found not substantially equivalent (NSE) to any identifiable predicate device. It allows the recipient of an NSE (not substantially equivalent) letter to request a risk-based classification determination to be made for the device.An applicant of a 510(k) who receives a Not Substantially Equivalent (NSE) determination placing the device into a Class III category can request a de novo classification of the product into Class I or II. The request must be in writing and sent within 30 days from the receipt of the NSE determination. In addition, the request should include a description of the device, labeling for the device, reasons for the recommended classification (into Class I or II), and information to support the recommendation. The de novo process has a 60 day review period. If FDA classifies the device into Class I or II, the applicant will then receive an approval order to market the device. This device type can then be used as a predicate device for other firms to submit a 510(k). However, if FDA determines that the device will remain in the Class III category, the device cannot be marketed until the applicant has obtained an approved PMA.7 FDA中的一个特别办公室8乃由旺盛增生的毛细血管及纤维结缔组织和各种炎性细胞组成，肉眼表现为鲜红色，颗粒状，柔软湿润，形似鲜嫩的肉芽故名9 The FDA also receives directly adverse drug event reports through its MedWatch program10 An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.11 2008年3月21日，美国FDA和美敦力公司（Medtronic, Inc）发布通告，对美敦力公司的Neuromodulation植入式输液泵进行I级召回12 comes from the Greek word nosokomeion(νοσοκομείον) meaning hospital (nosos = disease, komeo = to take care of13 In the United States, employers are required to withhold federal income tax, plus one-half of the Social Security tax, and one-half of the Medicare tax. Together, the employer's and employee's shares of the Social Security and Medicare taxes are known as the FICA tax14 The PDP is essentially a contract that describes the agreed upon details of design and development activities, the outputs of these activites, and acceptance criteria for these outputs. It establishes reporting milestones that convey important information to the FDA as it is generated, where they can be reviewed and responded to in a timely manner. The sponsor would be able to execute their PDP at their own pace, keeping FDA informed of its progress with these milestone reports. A PDP that has been declared completed by FDA is considered to have an approved PMA15光动力疗法（ Photodynamic Therapy ， PDT ）原称光辐射疗法（ Photoradiation Therapy ， PRT ）、光化学疗法（ Photochemical Therapy ， PCT ），它是利用光动力反应进行疾病诊断和治疗的一种新技术。