Скачать или смотреть FDA Makes a Critical Change in 2020

Check to see if your AED-Capable devices meet the new FDA standard:
https://www.fda.gov/medical-devices/c...

The FDA made a final order in February 2015 (Section 515(b)(1)(A) of the FD&C Act (21 U.S.C. 360e(b)) stating that current and future devices with an AED function would have to go through the more robust PMA process to carry the FDA’s approval. Not only does this include AED defibrillators for public access but also any ALS defibrillator in professional settings with AED or analyze functions. There are thousands of defibrillators currently located in hospitals, surgery centers and EMS organizations around the country that will be the affected. ...(read more)

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