mdi ConsultantsPresent Scenario:
The US Food and Drug administration is appealing for feedback on its proposal to bring into line its medical device labeling requirements with those in the EU by permitting the use of standardized stand alone symbols on device labels providing these are clarified in a supplementary symbols glossary. Regulations in the US at the moment do not allow stand alone symbols. If symbols are used they have to be come with an explanatory English text next to the symbol. However, in Europe, stand alone symbols are extensively used on device labels as they do away with the costs connected with translating the text into the 23 languages spoken there.
The FDA says that this has led to manufacturers having to change their labels for the US market and has produced confusion and industry criticisms that manufacturers have to create different labels for each market.
What does this proposed regulation essentially do?
- The proposed regulation seeks to harmonize US regulatory obligations with those in the EU by permitting the use of particular stand alone symbols, such as those developed by standards development organizations like the American National Standards Institution (ANSI), the International Organization for Standardization (ISO) and the International Electrotechnical Commission.
- The manufacturer must make sure that when using a standardized, stand alone symbol, a symbols glossary always accompanies the medical device. The FDA describes the term symbols glossary as a recorded listing of every symbol used in labeling of the device and of the meaning of, or explanatory text for, the symbol. The FDA’s website would have the latest information on which standardized symbols are accepted by the agency.
- The proposed rule gives manufacturers the choice of using stand alone symbols or continuing to label their devices with symbols and associated text. This means that the FDA would not compel manufacturers to use stand alone symbols for devices in the US market if they do not want to. But, for international manufacturers the potential to produce one label for worldwide distribution will be a huge help.
FDA’s stand for Prescription and IVD’s:
Regarding prescription devices and IVDs, even though the FDA does not allow stand alone symbols to be used on device labels, it has been using implementation discretion to allow labels of prescription devices to have the symbol statement “Rx only” without accompanying explanatory text.
If the FDA’s proposal is put into operation, it would favorably allow the use of this symbol statement as an alternative to the present statement expected on prescription de vices: “Caution”: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner)”.
For in vitro diagnostics also, the FDA has permitted the use of specific recognized symbols on IVD labels without explanatory text, despite the fact that this is not exactly permitted under present regulations. The proposed rule also tries to formally authorize the ability of IVD manufacturers to use stand alone symbols in labeling.
Credits:
mdi Europa GmbH