FDA's Premarket Approval and Other Approval Processes for Medical Devices
نویسندگان
چکیده
منابع مشابه
Express preemption and premarket approval under the Medical Device Amendments.
Millions of dollars are spent each year in an effort to develop new medical devices designed to help individuals facing serious medical conditions. However, before these devices can reach consumers, they must be reviewed and cleared by the Food and Drug Administration ("FDA"). Innovative medical devices which pose the greatest risks and are aimed at helping the most critically ill consumers are...
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The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved.
متن کاملGender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.
BACKGROUND Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. METHODS AND RESULTS We performed a systematic review of the demographics, comments on gender bias, and analysis of results by sex for 78 high-risk card...
متن کاملRegulatory approval of new medical devices: cross sectional study
OBJECTIVE To investigate the regulatory approval of new medical devices. DESIGN Cross sectional study of new medical devices reported in the biomedical literature. DATA SOURCES PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. ELIGIBILI...
متن کاملSelective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports
OBJECTIVE To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. DESIGN A search of the publicly available FDA database was performed for all cardiovascular de...
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ژورنال
عنوان ژورنال: JAPANES JOURNAL OF MEDICAL INSTRUMENTATION
سال: 1987
ISSN: 0385-440X,1881-4875
DOI: 10.4286/ikakikaigaku.57.8_382