Beyond Product Launch: Navigating FDA Post-Market Requirements for mHealth and Health ITVernessa T. Pollard
510(k)是提交给FDA的医疗器械上市前的申请。该过程适用于大多数II类设备以及一些I类和少数III类设备,这些设备被认定为中等风险,可以应用特殊控制措施,例如性能标准(Performance Standards)、上市后监督(Post-market Surveillance)和标签要求(Labeling Requirements),以获得合理的安全和有效性保证。 四、非实质等同(NSE)的...
benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products. Today, the FDA also issued 10 marketing denial orders (MDOs)...
This thesis examines relevant documents, books, and articles to identify FDA post-market requirements for the evaluation of customer complaints, investigation of device malfunctions, medical device reports, Corrective/Preventative Actions (CAPA), and field corrections or removals. The thesis also provides...
Ability of other postmarket mechanisms to address public health concerns raised by the postmarket question We will consider whether other mechanisms may address the question, such as postapproval requirements (21 CFR 814.82), medical device reports (MDR) (21 CFR Contains Nonbinding Recommendations Part...
post-market clinical follow-up (PMCF) studies. Even products with clinical studies might require post-market clinical follow-up (PMCF) because the clinical studies may not cover changes to the device, accessories, and range of sizes.MEDDEV 2.12/2provides guidance on the requirements for post-...
Two factors could be used to determine the pre- and post-market requirements for each SaMD review: The SaMD organization's standing in the FDA Pre-Cert program; and The risk categorization of the SaMD being evaluated. Organizations that demonstrate a commitment to organizational excellence could...
POST-OR PRE- MARKET SURVEILLANCE:销售前或销售后监督 INFORMED CONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接 受治疗或试验) PRESCRIPTION DRUG:处方药 OTC DRUG(OVER—THE—COUNTER DRUG):非处方药 U.S.PUBLIC HEALTH SERVICE:美国卫生福利部 NIH(NATIONAL INSTITUTE OF HEALTH):(美国)全国卫...
US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging... BackgroundDose optimization is a focal point of many US Food and Drug Administration (FDA) drug approvals. We sought to understand the...
these scientific advances, which hold out tremendous potential for treating and even curing diseases. To achieve these goals, we need to make sure that we have a modern regulatory framework in place that can allow innovators to meet the statutory requirements for demonstrating safety and ...