FDA Issues Final Rule on Symbols in Labeling - Recorded Webinar

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Webinar Duration: 60 minutes

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SPEAKER: David R. Dills

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 finale rule is optional, though the agency thinks that it will be a boon to 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 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, 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

David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.
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