Overview:
The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.
FDA back in June 2016 issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards. In addition to allowing the use of standalone symbols, the final rule also permits the use of the symbol statements "Rx only" and "Rx only" for prescription devices. FDA says the final rule is optional, though the agency thinks that it will be a boon to the industry and estimates the reduced workload will result in annual savings of up to $25.5 million.
In the past, FDA prohibited companies from using standalone symbols on device and IVD labels, and required symbols on the labels to be accompanied by explanatory text. However, in 2013, after pressure from the medical device industry, FDA issued a proposed rule that would allow standalone symbols to appear on device labels for public comment. In its comments on the proposed rule, the Advanced Medical Technology Association (AdvaMed) called FDA's previous approach inefficient, saying that "adding adjacent English text eliminates the inherent advantage of using internationally recognized symbols." Now, under the final rule, the agency will allow the use of such symbols, as long as they meet certain requirements.
Until now, medical devices require symbols with explanatory text except for in vitro diagnostic devices. Medical device manufacturers are not required to change the labeling of their devices to include the symbols unless they feel it will better benefit them. Allowing symbols to stand without accompanying explanatory text will bring the U.S. rules in line with many international regulatory authorities and industry organizations, such as the European Union, the International Electrotechnical Commission, and the International Organization for Standardization.
Areas Covered in the Session:
- Introduction to the Final Rule
- Purpose of the Regulatory Action
- Standalone symbols explained in a paper or electronic glossary included with the device, despite industry requests to eliminate the glossary requirement
- Allows manufacturers to use standalone symbols not recognized by FDA in addition to those that are developed by recognized standards development organizations (SDOs)
- FDA says companies can still use standalone symbols from standards not recognized by the agency with a caveat
- Standards Development Organization (SDO)
- Options for Using Stand-Alone Symbols
- Examples of comments provided by industry during the proposed Rule
- Understand the labeling requirements for various product types
- Labeling Information Not Required
- Matters Relating to the Extent to Which Symbols Can Be Used
- Symbols Glossary Requirement
Who Will Benefit:
- All levels of management and departmental representatives and any anyone who desires a better understanding of the Final Rule, its interpretation, and applicability
- CRO's
- Regulatory SME's
- Regulatory Affairs
- RA Specialists
- Clinical Affairs
- Project Leaders for Labeling Operations
- Quality Control/Quality Assurance
- Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Engineering/Technical Services
- Consultants
- Manufacturing
- Auditors