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All definitions in section 201 of the act shall apply to the regulations in this part.
Legal manufacturer definition medical devices fda. T manufacturer means any legal person or entity engaged in the manufacture of a product subject to license under the act. A act means the federal food drug and cosmetic act as amended secs. Manufacturer means the natural or legal person with responsibility for the design manufacture packaging and labelling of a device before it is placed on the market under his own name regardless of whether these operations are carried out by that person himself or on his behalf by a third party. Manufacturer makes by chemical physical biological or other procedures any article that meets the definition of device in section 201 h of the federal food drug and cosmetic fd c act.
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 out by that person himself or on his behalf by a third party. Introduction to medical device labeling label vs. If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to the fda s laws and regulations before during and after it is. Manufacturer also includes any legal person or entity who is an.
B complaint means any written electronic or oral communication that alleges deficiencies related to the identity quality durability reliability safety. 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. The medical device reporting mdr regulation 21 cfr part 803 contains mandatory requirements for manufacturers importers and device user facilities to report certain device related adverse.
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