From the FDA: http://www.fda.gov/MedicalDevice
Post# of 1782
Posted On: 07/13/2016 2:44:42 PM
From the FDA:
http://www.fda.gov/MedicalDevices/DeviceRegul...ult.htm#se
The MFST device has received a "Substantial Equivalence" decision from the FDA. Here is an explanation of what "Substantial Equivalence" is (pay attention to BOLD phrase at bottom):
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA; ?does not raise new questions of safety and effectiveness; and
?demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
• resubmit another 510(k) with new data,
• request a Class I or II designation through the de novo process
• file a reclassification petition, or
• submit a premarket approval application (PMA).
It's quite possible since this decision just occurred on 7/8/2016 that MFST has not received the LETTER from the FDA yet. Once they receive the letter I'm sure we'll get a PR from the company. Have a nice day! smile
http://www.fda.gov/MedicalDevices/DeviceRegul...ult.htm#se
The MFST device has received a "Substantial Equivalence" decision from the FDA. Here is an explanation of what "Substantial Equivalence" is (pay attention to BOLD phrase at bottom):
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA; ?does not raise new questions of safety and effectiveness; and
?demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
• resubmit another 510(k) with new data,
• request a Class I or II designation through the de novo process
• file a reclassification petition, or
• submit a premarket approval application (PMA).
It's quite possible since this decision just occurred on 7/8/2016 that MFST has not received the LETTER from the FDA yet. Once they receive the letter I'm sure we'll get a PR from the company. Have a nice day! smile
(1)
(0)Medifirst Solutions Inc. (MFST) Stock Research Links
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