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Medical Device Labeling under FDA
Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on food, drugs, medical devices, biologics, cosmetics and even radiation emitting electronic products. The labelling regulations related to medical device labels are present under 21 Code of Federal Regulations (CFR).
FDA Labeling Requirements:
FDA has a list of labeling guidelines depending on the product that is being manufactured. So, it has segregated all the guidelines in accordance with their part number. Below is a list that mentions the CFR part number that is to be referred to achieve the labeling benchmark.
- 21 CFR Part 801- Generalized Device Labeling
- 21 CFR Part 801.15 – Application of Symbols
- 21 CFR Part 809 – In-Vitro Diagnostic Devices
- 21 CFR Part 812 – Exemptions for Investigational Devices
- 21 CFR Part 830 – UDI Regulations
- 21 CFR Part 820 – GMP Regulations
- 21 CFR Part 1010 – General Electronic Product Regulations
General Labeling Instructions:
There are some areas that have been highlighted by the FDA and which needs to be present on the labels of every medical device. Such a list of details is mentioned below:
- Name and Location of Business- These are essential so that the name of the manufacturer and the place of manufacturing are visible to the buyer.
- Purpose of Use- The label should contain the intended purpose of use. So that whoever purchases the devices knows its usages if any other than the one that it is being purchased for.
- Instructions of Use- The directions of use needs to be written in a layman’s language so that the patient or the caregiver can easily understand and use the device safely.
- No Misleading Statements- False statements are equivalent to misbranding and would be penalized if it is found that the device label mentions something that is against the working of the device.
- Highlighting Prominent Statements- Every important and critical statements should be given prominence on the product label. Instead of putting too much unnecessary data, relevant information needs to be highlighted.
Other that these generalized labelling instructions there are several specific labelling guidelines that FDA has. These are to be followed by the manufacturers based on the product they are manufacturing.
