Fda Ceramic Regulations

Of health and human services regulations and fine and comment on other hhs rules.

Fda ceramic regulations.

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. For the most up to date version of cfr title 21 go to the electronic code of federal regulations ecfr. Use of approved components drug product containers and closures. 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.

52 a e. 872 9 limitations of exemptions from section 510 k of the federal food drug and cosmetic act the act. 872 3 effective dates of requirement for premarket approval. Degree of compliance of the commodity country firm combination with the laws enforced by fda and their implementing regulations and fda s level of.

Fda has identified dietary lead exposure as a significant public health issue. Fda 2013 s 0610 specific electronic submissions intended for fda s dockets management. 872 1720 pulp tester. Subpart b diagnostic devices 872 1500 gingival fluid measurer.

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. 872 1730 electrode gel for pulp testers. Daily use ceramicware means ceramic. Components drug product containers and closures approved for use shall be rotated so that the oldest approved stock is used first.

Federal food and drug regulations search for title 21 of the cfr food and drugs hhs regulations search top dept. 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. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. Imported and domestic ceramic ware has been found to have significant quantities of extractable cadmium.

Limits of lead range from 0 5 ppm for mugs to 3 ppm for plates and flatware.