Legal Manufacturer Definition Medical Devices Fda

Fda determines the intended use of a medical device by looking at a wide body of evidence such as.

Legal manufacturer definition medical devices fda.

Legal manufacturer means the manufacturer of a medical device in the meaning of the german medical devices act hersteller directive 98 79 ec and other applicable laws i e. In europe a medical device manufacturer is the entity whose name is on the label and who assumes responsibility for design manufacture packaging and labeling. The natural or legal person who is responsible for the design manufacture packaging and labeling of a device before it is placed on the market under his own name regardless of whether these operations are carried. A act means the public health service act 58 stat.

B secretary means the secretary of health and human services and any other officer or employee of the department of health and human services to whom the authority involved has been delegated. C commissioner of food and drugs means the commissioner of the food and drug administration. Introduction to medical device labeling label vs. Labeling claims advertising matter or oral or written statements or circumstances that show the medical device is with the knowledge of the manufacturer offered and used for a purpose for which it is neither labeled nor advertised.

The good news is that a manufacturer s obligations and the requirements for ce marking a medical device are delineated in the. Food and drug administration fda develops and administers regulations under authority granted by laws passed by congress that. With the publication of europe s new medical device regulation eu 2017 745 and in vitro diagnostic regulation eu 2017 746 some companies that contract manufacture or relabel devices are wondering if they will be considered the legal manufacturer of the device they sell much of the confusion around this issue stems from the assumption that there can be only one legal manufacturer. Visit the medical devices webpage for more information.

Legal claimed manufacturer by european directive regulations the manufacturer is responsible for the design manufacturing packaging and sale of a product placed on the european market under his own name whether he is actually fulfilling those tasks or subcontracting them. As used in this subchapter. When a company a is selling medical devices onto the european market as an own brand labeler which means that company a is buying an already finished medical device from company b and places it on the european market under their own name a then company a is seen as the legal manufacturer. The center for devices and radiological health cdrh is the fda center responsible for overseeing the medical device program.