Fda Ceramic Regulations

872 9 limitations of exemptions from section 510 k of the federal food drug and cosmetic act the act.

Fda ceramic regulations.

Fda 2013 s 0610 specific electronic submissions intended for fda s dockets management. A hip joint metal ceramic polymer semi constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. 872 3 effective dates of requirement for premarket approval. Lead and cadmium are components of the glaze used in making ceramicware and can leach into foods in significant amounts when the glaze is improperly formulated applied or fired.

The division of compliance programs of the food and drug administration interprets the regulations for food additives which covers the leachability of lead and cadmium for glazed ceramic surfaces by use of the standard method of test astm c738 72. Components drug product containers and closures approved for use shall be rotated so that the oldest approved stock is used first. Subpart a general provisions 872 1 scope. 52 a e.

Imported and domestic ceramic ware has been found to have significant quantities of extractable cadmium. The information on this page is current as of april 1 2019. Ceramic bowls tan in color with light green band 1 25 2007. Limits of lead range from 0 5 ppm for mugs to 3 ppm for plates and flatware.

For the most up to date version of cfr title 21 go to the electronic code of federal regulations ecfr. Fda is issuing this guidance to industry to address our concerns about the safety and labeling of imported traditional pottery including imported mexican terra cotta pottery and the use of the. Of health and human services regulations and fine and comment on other hhs rules. Daily use ceramicware means ceramic.

Subpart b diagnostic devices 872 1500 gingival fluid measurer. Fda has identified dietary lead exposure as a significant public health issue. Federal food and drug regulations search for title 21 of the cfr food and drugs hhs regulations search top dept. 872 1730 electrode gel for pulp testers.

This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces.