The Food and Drug Administration (FDA) has announced the opening of a docket dedicated to receiving comments on guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in fiscal year 2015, as well as for previously-issued guidances that may be in need of revision or withdrawal. While FDA welcomes comments on guidance documents at any time, to ensure consideration under this particular solicitation, comments should be received no later than March 10, 2015. The guidance documents up for review are grouped into categories described below.

While negotiating the Medical Device User Fee Amendments of 2012 (MDUFA III), FDA agreed to meet a number of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. These goals included:

  • Annually post a list of prioritized device guidance documents that it intends to publish within 12 months of the date the list is published each fiscal year (the “A-list”);
  • Annually post a list of device guidance documents that it intends to publish as resources permit each fiscal year (the “B-list”);
  • Maintain its website to reflect its review of previously published guidance documents, including the deletion of guidance documents that no longer represent the current interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by FDA; and
  • Provide stakeholders an opportunity to provide feedback, including draft language for guidance documents.

Prioritized medical device guidance documents that the Agency intends to publish in FY15 (“A-list”) includes the following:  Final Guidance Topics

  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design
  • 510(k) Submissions for Medical Devices that Include Antimicrobial Agents
  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
  • Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions
  • Framework for Regulatory Oversight of Laboratory Developed Tests
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests
  • Coronary Drug Eluting Stents-Nonclinical and Clinical Studies
  • Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
  • Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-bore Connectors Intended for Enteral Applications
  • Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)

Draft Guidance Topics

  • General Wellness Products
  • Medical Device Accessories
  • Medical Device Decision Support Software
  • Benefit-Risk Factors to Consider When Reviewing IDE Submissions
  • UDI Direct Marking
  • Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
  • Adaptive Design for Medical Device Clinical Studies
  • UDI FAQs

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit in FY15 (“B-list”) includes the following:  Final Guidance Topics

  • Finalizing Existing Draft Guidance Documents

Draft Guidance Topics

  • Medical Device Interoperability
  • Transfer of Ownership of a Premarket Notification: Questions & Answers
  • Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing)
  • Patient Access to Information
  • 3D Printing (Technical)
  • Manufacturing Site Change Supplements
  • Use of Symbols in Labeling

CDRH intends to provide such lists annually through fiscal year 2025 so that, by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. FDA is inviting comment on the list of FY15 to-be-issued guidances, including draft language on the A-list and B-list topics, recommendations for new or different guidance documents, and as mentioned above, input as to the relevance of previously-issued guidance documents.

CDRH noted that, while it fully expects to publish the A-list in its entirety and the B-list as resources permit, prior experience has shown that there are numerous reasons why it is unable to complete the entire annual agenda. For that reason, the Agency is inviting comment regarding the relative priority of different guidance topics to interested stakeholders.

The opening of this docket and the comment solicitation presents an opportunity for interested parties to review what CDRH has on its agenda for FY15, propose new topics and present opinions regarding the significance of newly emerging technologies, and offer valuable input as to the relevance of possibly outdated issues.