In June, FDA finally dropped their requirement for symbols for device labels to be explained with adjacent text and now allows the use of standalone symbols on medical device and In Vitro Diagnostic (IVD) labels as long as certain requirements are met.
Those working in labeling are aware of the painful exercise of trying to cram symbols and text onto a small label and include lengthy lists of symbols in instructions for use manuals defining each symbol.
The Agency estimates that this new rule will result in a decreased workload and savings to Industry of over $25 million dollars. No more requirements for special US labels with explanatory text under the symbols (which negated the advantages of using symbols). While this will reduce the label inventory workload and packaging and labeling size to accommodate the text and symbol, FDA still requires manufacturers to provide a glossary of all the symbols in a paper or electronic format that is included with the device.
Whether Industry sees a reduction in medical device manufacturing cost as a result of this new rule is yet to be seen.
In addition to allowing symbols developed by recognized Standards Development Organizations (SDOs) to be used, FDA says companies can still use standalone symbols from standards not recognized by the agency. These non-recognized standard symbols can be used if “the manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the [Federal Food, Drug and Cosmetic Act (FD&C)] and uses the symbol according to the specifications for use set forth in the SDO-developed standard”.
FDA is also allowing manufacturers to decide for themselves if a symbol is likely to be read and understood, which is considered “consistent with what industry currently does when it uses text in labeling,” though the agency notes it still has authority to determine whether a symbol is in compliance with the rule.
The final rule also permits the use of the symbol statements “Rx only” and “℞ only” for prescription devices.
Use of standalone symbols is optional and manufacturers can still choose to use the adjacent explanatory text.
Despite criticism that a glossary for symbols for device labels is still required, this new rule is an important step towards global medical device harmonization and hopefully will allow for a decrease in manufacturing costs as well. I would love to hear from readers on their experiences with cost savings.
Virginia Anastassova, RAC, is the Regulatory Affairs Manager/ Senior QA Specialist at StarFish Medical. She brings extensive experience in quality management and regulatory affairs to our clients.
StarFish Medical Director of Quality Assurance and Regulatory Affairs, Vesna Janic, and Quality Assurance and Regulatory Affairs Specialist, Cam Neish, deliver two expert presentations focused on strategies for handling FDA inspections and managing risk associated with medical devices at the 5 October 2016 RAPS Vancouver BC chapter meeting in Burnaby, BC. More info at http://iz3.me/DQSJ3zWXX0F1
Image © Nils Ackermann | Dreamstime.com – Electronic healthcare (e-health) concept with hand holding smart phone to access digital medical records of patients