Change control is a procedure for ensuring that changes to any product within scope of quality management system are planned, approved and implemented in a controlled manner maintaining safety and efficacy of the product. The company have to decide they will go for letter-to-file or a special PMA/510(K) supplement. Letter-to-file remains internal in the company while PMA/510(K) depends on regulatory path of original devices. The company should do analysis and testing that whether the change have could have impact on device safety and efficacy. After the analysis and testing are done results should be packed in letter -to -file or send to FDA The control changes reduces the defects and increases the end user satisfaction . The major factors that cause change in a medical device are due to labelling, engineering and technology , performance