FDA Issues Final Rule on Symbols in Labeling

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By attending this webinar you will learn the labeling requirements for various product types, Standalone symbols explained in a paper or electronic glossary included with the device, despite industry requests to eliminate the glossary requirement.
David Dills   Product Id : 501864
  Instructor : David Dills

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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

Speaker Profile
David R. Dills, Global Regulatory Affairs & Compliance Consultant, President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customergenerated compliance events, and prepares for and conducts QS and regulatoryaudits. He is currently acting and interim President at NovaQual LLC.

He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing responses to AI’s/deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and postmarket project leadership and guidance covering different therapeutic and medical specialties based on classification.

Mr. Dills has a strong background in the interpretation and applicabilityofFDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities forthe registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk forcompanies.

Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted bythird-partyconsultancies and provides services involving all phases ofthe product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; UDI compliance strategies; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-countryproduct registrations and licensing

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE, CTD/CMC and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance.

Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and 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; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; conducts MDSAP training; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; assist companies during FDA and other regulatory authorities’ inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions foroverall corporate compliance to support a company’s goals andstrategies.

Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with regulatoryauthorities; executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance withregulations in The Americas, EMEAand Asia Pacific. He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

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 associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

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