Chapter: 22-B103
LABELING OF MEDICAL DEVICES 

Title: 22 HEALTH
SubTitle: 22-B PUBLIC HEALTH AND MEDICINE


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Section Number Section Heading Latest Version Effective Date
22-B10300 MEDICAL DEVICES: NAME AND PLACE OF BUSINESS OF MANUFACTURER, OR DISTRIBUTOR View text 7/12/2013
22-B10301 MEANING OF "INTENDED USES" View text 7/12/2013
22-B10302 RESERVED View text 7/12/2013
22-B10303 MEDICAL DEVICES: MISLEADING STATEMENTS View text 7/12/2013
22-B10304 MEDICAL DEVICES: PROMINENCE OF REQUIRED LABEL STATEMENTS View text 7/12/2013
22-B10305 MEDICAL DEVICES: SPANISH LANGUAGE VERSION OF CERTAIN REQUIRED STATEMENTS View text 7/12/2013
22-B10306 PRINCIPAL DISPLAY PANEL View text 7/12/2013
22-B10307 STATEMENT OF IDENTITY View text 7/12/2013
22-B10308 DECLARATION OF NET QUANTITY OF CONTENTS View text 7/12/2013
22-B10309 MEDICAL DEVICES: WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS AND OTHER CLASS I OZONE-DEPLETING SUBSTANCES View text 7/12/2013
22-B10310 PRESCRIPTION DEVICES View text 7/12/2013
22-B10311 RETAIL EXEMPTION FOR PRESCRIPTION DEVICES View text 7/12/2013
22-B10312 MEDICAL DEVICES HAVING COMMONLY KNOWN DIRECTIONS View text 7/12/2013
22-B10313 IN VITRO DIAGNOSTIC PRODUCTS View text 7/12/2013
22-B10314 DEVICES FOR PROCESSING, REPACKING, OR MANUFACTURING View text 7/12/2013
22-B10315 MEDICAL DEVICES FOR USE IN TEACHING, LAW ENFORCEMENT, RESEARCH, AND ANALYSIS View text 7/12/2013
22-B10316 MEDICAL DEVICES: EXPIRATION OF EXEMPTIONS View text 7/12/2013
22-B10317 OTHER EXEMPTIONS - MEDICAL DEVICES: PROCESSING, LABELING, OR REPACKING View text 7/12/2013
22-B10318 SPECIAL REQUIREMENTS FOR SPECIFIC DEVICES - LABELING OF ARTICLES INTENDED FOR LAY USE IN THE REPAIRING OR REFITTING OF DENTURES View text 7/12/2013
22-B10319 USE OF IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES View text 7/12/2013
22-B10320 MAXIMUM ACCEPTABLE LEVEL OF OZONE View text 7/12/2013
22-B10321 CHLOROFLUOROCARBON PROPELLANTS View text 7/12/2013
22-B10322 HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING View text 7/12/2013
22-B10323 HEARING AID DEVICES: CONDITIONS FOR SALE View text 7/12/2013
22-B10324 USER LABELING FOR MENSTRUAL TAMPON View text 7/12/2013
22-B10325 WARNING STATEMENTS FOR PRESCRIPTION AND RESTRICTED DEVICE PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS OR OTHER OZONE-DEPLETING SUBSTANCES View text 7/12/2013
22-B10326 USER LABELING FOR LATEX CONDOMS View text 7/12/2013
22-B10327 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER View text 7/12/2013
22-B10399 DEFINITIONS View text 7/12/2013