When bringing a medical device into market company will determine whether to submit 510(K) or PMA. If the company could not make right decision getting unsafe product in customer’s hands causes serious damage and product failure. The class II devices are important for healthcare but also have less risk to user requires 510(K) submission while the class III devices are mostly implanted devices whose malfunction can cause adverse outcome for patients requires PMA before marketed . For 510(K) submission you needs to prove that your device equivalency to a predicate device ,no clinical trials are required .For PMA ,it should be proved that new device is safe and effective which requires clinical trials .The 510(K) submission can be used to reduce time and cost in case of device where there is no concern of safety and health. PMA is more time consuming requires number of clinical trials and each step should be documented proving reliability and GLP must be followed which cost millions of dollars. There is huge difference between complexity and length of document between 510(K) and PMA. Medical device manufacturer found it difficult which submission should be sought. The company should wisely decide the right path for submission before product being marketed.