2016 FDA Guidance Documents You Should Know

These were the most important guidance documents of the year for medical device manufacturers.

Gordon MacFarlane, PhD, RAC and Cynthia Nolte, PhD, RAC

This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer.

Adaptive Designs for Medical Device Clinical Studies (Final Guidance)

What FDA Says: Guidance on planning and implementing adaptive designs for clinical studies used in medical device development. It includes definitions, when to choose adaptive designs, using adaptive designs in blinded and unblinded studies, examples of various adaptive designs and potential challenges. Also recommends consulting with FDA in developing adaptive trials, and applies to PMA, 510(k), de novo, humanitarian, and investigational device exemption submissions at all trial stages.

Benefit: FDA encourages and provides useful guidance for using adaptive designs that can improve trial efficiency.

Challenge: Adaptive designs require extra planning and precise execution to be effective.

Path Forward: Develop expertise in applying and executing adaptive designs in collaboration with FDA and experienced partners as needed.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Draft Guidance)

What FDA Says: Outlines when real-world evidence (RWE) derived from non-traditional data sources, such as electronic medical records and registries, can be used to support regulatory decisions for new or updated devices.

Benefit: Widens data pool supporting device decisions, which could reduce research costs and shorten development cycles.

Challenge: Establishing scientific rigor in alternative data sources.

Path Forward: Work with FDA before submission to determine what RWE is acceptable for specific devices, indications and patient populations.

Human Factors Studies and Related Clinical Study Considerations in Combination  Product Design and Development (Draft Guidance)

List of Highest Priority Devices for Human Factors Review (Draft Guidance)

What FDA Says: Guidance provides principles of human factor engineering and how to apply them in combined medical products that contain drug and device components. Priority review draft guidance lists device categories requiring human factor review, and outlines FDA's approach for determining if a product filing requires human factor data.

Benefit: Integrating human factors engineering into device design helps ensure users operate devices safely and effectively. This can save time and cost detecting and correcting design or user errors after device approval.

Challenge: Developing a human factors test program requires significant time and resources. Timing can be difficult as final design must be used and testing complete before use in humans.

Path Forward: FDA is continuously refining guidance in human factors engineering. Keeping up can help programs address evolving approval requirements.

Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance)

What FDA Says: To reduce the risk of harm due to evolving cybersecurity threats, manufacturers of medical devices that use software or programmable directions should develop an ongoing program to identify, assess, and mitigate new risks.

Benefit: Proactively mitigating cybersecurity threats reduces risk of patient harm from device malfunctions due to software interference or failure.

Challenge: Identifying and mitigating continually evolving cybersecurity risks as technology progresses.

Path Forward: Continued clarification of cybersecurity risk management program requirements, and sharing information and intelligence that manufacturers can use to keep devices safe.

Deciding When to Submit a 510(k) for a Change to an Existing Device (Draft Guidance)

Deciding When to Submit a 510(k) for a Software Change to an Existing Device (Draft Guidance)

What FDA Says: The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case examples with explanations why a 510(k) is or is not needed, and documentation required if a 510(k) is not needed. The software guidance focuses on how to determine when a software change requires filing a 510(k).

Benefit: Clarifies when changes to a device or its software requires a 510(k), which may improve consistency of filing decisions.

Challenge: Cannot cover all possible changes to myriad devices, so application still requires interpretation.

Path Forward: Integrate the assessment approaches in the FDA guidance into procedures for evaluating regulatory implications of proposed device or software change.

Medical Device Reporting for Manufacturers, Guidance for Industry and Food and Drug Administration Staff (Final Guidance)

What FDA Says: Outlines manufacturer's responsibilities for reporting adverse events to FDA. Unless exempted, manufacturers must implement written procedures addressing Medical Device Reporting (MDR) requirements. Guidelines for follow-up investigations and addressing event reports in the medical or scientific literature are included.

Benefit: Answers to basic questions and recommendations for addressing scenarios help comply with MDR requirements.

Challenge: Guidance does not address investigation issues, such as obtaining devices and patient information, after an event.

Path Forward: Inadequate MDR procedures are among the most common deficiencies identified in FDA manufacturer inspections. This guidance helps ensure MDR reporting processes and documentation are compliant.

Gordon MacFarlane, PhD, RAC, is senior manager of regulatory affairs at ICON plc.

Cynthia Nolte, PhD, RAC, is director of regulatory affairs at ICON plc.

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