Legal Manufacturer Definition Medical Devices Fda

C commissioner of food and drugs means the commissioner of the food and drug administration.

Legal manufacturer definition medical devices fda.

The good news is that a manufacturer s obligations and the requirements for ce marking a medical device are delineated in the. The center for devices and radiological health cdrh is the fda center responsible for overseeing the medical device program. 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. This means that an own brand labeler has got the.

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. 682 approved july 1 1944. Food and drug administration fda develops and administers regulations under authority granted by laws passed by congress that. 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.

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. Introduction to medical device labeling label vs. Visit the medical devices webpage for more information. 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 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. Fda determines the intended use of a medical device by looking at a wide body of evidence such as. A act means the public health service act 58 stat. 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.