Exploration of Instruction for use and General Information Displayed on Dental Material and Device Labels/Packages
Author(s):
Pranjali kshirsagar, Chetna Dhande, Vinita Kale
Keywords:
Abstract
The regulatory agency (including FDA) regulates the marketing approval, licensing and clearance of OTC products (including dental material) to ensure product safety and effectiveness. The agency further extends its regulation to labelling and promotion of the product. Dentistry is the branch of medicine that is involved in the study, diagnosis, prevention, and treatment of diseases, disorders and conditions of the oral cavity. Although the practice of dentistry is governed by State law and regulations but dentist and patient must be aware of safety of the product. This can be achieved by proper labelling practice that can protect patients from adverse errors. Based on the data obtained, a unique packaging standardization checklist was developed. An exploratory cross sectional study was performed using various search engines and websites to access the laws and regulations existing pertaining to dental materials packaging. This study considered 16 brands of dental material instruments for analysis. Analysis was performed using the direct observation checklist. Conclusion: This study found lower rate of adherence to the guidelines, thus indicating insufficient information being disclosed to the consumers. The general labelling provisions for dental devices and the elements of comprehensive reprocessing instructions as per FDA Guidance Document need to be added on the labels.
Article Details
Unique Paper ID: 161367

Publication Volume & Issue: Volume 10, Issue 4

Page(s): 365 - 368
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