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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
In general they are subject to Class 2 controls and hence require a 510(k), though individual PACS components may be subject to less stringent general controls. [11] Some specific applications, such as the use for primary mammography interpretation, are additionally regulated [ 12 ] within the scope of the Mammography Quality Standards Act .
The Supreme Court on Thursday revived a requirement that owners of millions of small businesses register with an arm of the Treasury Department charged with fighting money laundering and other ...
DOGE members accessed computer systems to search for staff and data related to diversity programs. USAID. Musk announced on Feb. 2 that he was going to shut down the U.S. Agency for International ...
The Animal Project NYC is being challenged with a near-impossible task this week, attempting to find homes for more than a dozen cats by Thursday, Jan. 23. A Bronx woman had been hoarding the cats ...
The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any point in time and the participant is not required to reveal the reason for discontinuation.
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