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Medical device labeling procedure. 1 to assist manufacturers in their development and 2 to assist center reviewers in their review and evaluation of medical device patient labeling to help. Frm 033 a new eu mdr labeling requirements checklist. These documents are updated for iso 13485 2016 and the new european regulations. Sys 030 a labeling translation procedure.
The following is a list of documents included. The focus of these controls is to ensure that labels are accurately designed and properly applied to the correct products. This guidance serves a dual purpose. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.
2 2 other regulations exist with respect to medical device labeling e g. If your medical device company is planning to sell devices in the united states you will need to comply with the fda qsr for labeling and packaging control of medical devices found in 21 cfr part 820 120. By the fda but these are not covered by this procedure. General device labeling 21 cfr part 801 use of symbols.
Most auditors and fda inspectors request a copy of a labeling procedure to verify compliance with the first requirement. Labeling checklist forms and labeling templates are included with the procedure. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. In their notes they record the document number and revision of the procedure.
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