{"id":3664,"date":"2021-09-09T23:33:29","date_gmt":"2021-09-09T23:33:29","guid":{"rendered":"http:\/\/deepfda.com\/?p=3664"},"modified":"2021-09-09T23:33:29","modified_gmt":"2021-09-09T23:33:29","slug":"%e7%be%8e%e5%9b%bdfda-pma-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0","status":"publish","type":"post","link":"https:\/\/deepfda.com\/us\/%e7%be%8e%e5%9b%bdfda-pma-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/","title":{"rendered":"\u7f8e\u56fdFDA PMA \u533b\u7597\u5668\u68b0"},"content":{"rendered":"

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Medical Devices<\/span>FDA Medical Devices Application<\/span><\/span><\/h3>
U.S. FDA Medical Device 510(k)<\/div><\/header>
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Contact Our Medical Device Team<\/span><\/a><\/div>
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Medical Devices<\/span>Obtain U.S. Marketing Authorization<\/span><\/span><\/h3>
Any medical device intended for sale in the United States must obtain marketing authorization<\/div><\/header>
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Any Class I, II, or III medical device intended for sale in the U.S. must submit a 510(k) to the FDA, unless the device qualifies for a 510(k) exemption under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements for 510(k) submissions are outlined in 21 CFR 807 E. Prior to marketing the device, the submitter must receive a letter from the FDA confirming that the device is substantially equivalent (SE) to a legally marketed device of the same type that has already been cleared for sale in the U.S.<\/p>\n

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Contact Our Medical Device Team<\/span><\/a><\/div>
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Data Organization and Analysis<\/span>Testing Data Required for Medical Device Applications<\/span><\/span><\/h3><\/header>
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Contact Our Medical Device Team<\/span><\/a><\/div>
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Medical Devices<\/span>Medical Device Substantial Equivalence<\/span><\/span><\/h3>
Medical Device 510(k) Substantial Equivalence Documentation Submission<\/div><\/header>
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A 510(k) is a premarket submission to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device, meaning it is substantially equivalent (per FD&C Act Section 513(i)(1)(A)). The submitter must compare their device with one or more similar legally marketed devices and provide evidence to support their substantial equivalence claim.<\/p>\n

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Contact Our Medical Device Team<\/span><\/a><\/div>
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Contact Our Medical Device Team<\/span><\/span><\/a><\/div>
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