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The document is a 510(k) premarket notification for the SonoSite Hand-Carried Ultrasound System (Cl Series), submitted by SonoSite, Inc. It outlines the device's safety and effectiveness, including its intended use for diagnostic ultrasound imaging of small organs such as the breast, thyroid, testicles, and prostate. The submission adds this new clinical application to previously cleared indications without any technological changes. The document also details compliance with various FDA standards and concludes that the device is substantially equivalent to a predicate device.

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How does the FDA ensure drug safety?

The FDA approval process requires comprehensive pre-clinical testing followed by multi-phase clinical trials to ensure safety and efficacy.

How does the FDA ensure the safety and effectiveness of drugs?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

How does the FDA ensure that over the counter drugs are safe and effective?

To further ensure the safe use of OTC products, FDA conducts studies to learn if potential OTC consumers understand the Drug Facts label, can properly choose the medicine for their needs, and use it ing to the directions.

What is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices?

FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself.

What is 510k summary of safety and effectiveness?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).