510k Vs Premarket Approval

 

510k Vs PMA : Its Purpopse 

510k : The purpose of a 510k submission is to provide the FDA with documented evidence which proves that your medical device is substantially equivalent to a predicate device, one that has already been approved for marketing by the FDA. The FDA processes 510k submissions in 30-90 days. 

PMA : A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing. The standards here are much higher than for 510k submissions, and the FDA has just 180 days to accept or reject the application.

In the scenario of 510k Vs PMA : 

510(k) premarket notification means to prove the substantial equivalence between subject device and a predicate device. Predicate device is a legally marketed 510(k) cleared devices. There are 3 types of 510(k) premarket notification process to FDA.

• Traditional
• Abbreviated
• Special

Difference between the 510k Vs PMA : 

Premarket approval (PMA) (21 CFR 814.39) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Due to the level of risk associated with Class III devices, FDA requires sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). The content of PMA is similar to the NDA for new drugs, and contains manufacturing sections, pre-clinical laboratory studies and clinical investigations.

510(k) The name refers to requirements outlined in section 510(k) of Food, Drug and Cosmetics Act. If the device is considered to be substantially equivalent to one or more similarly marketed devices (known as “predicate” devices), a claim of substantial equivalence can be made. 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 and other parameters.

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