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A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).
A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and design control requirements under the Quality System (QS) regulation. FDA provides guidance on how to meet the QS regulation requirements, under which all Class II and III devices and certain Class I devices have to be designed in conformance to 21 CFR 820.30 Design Controls.
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Medical device companies which submit their premarket notification to the FDA for approval signal their intent to market their device. This submission has to be done at least 90 days before they register the product. Some logical and commonsensical steps have to be followed in designing a bullet proof 510 (K), meaning that the PMA is strong and not capable of being rejected by the FDA. Medical device manufacturers can follow these structured steps for designing a bullet proof 510 (K):