In the absence of narrative assurances, FDA 510(k) cybersecurity deficiencies must be addressed with evidence that can be easily audited and provided. If a 510(k) is placed on a hold (Refuse to Accept- RTA) or additional information is requested (Additional Information – AI), the FDA decision clock is halted and the sponsor has a 180-day period, with no extension allowed, to submit a complete response to the FDA. The questions may stem from a cybersecurity firm’s lack of the security controls themselves but from a failure to identify potential risks and find test evidence or verify claims efficiently.

In this live webinar, Qualysec Technology is going to explore the nuts and bolts of the FDA deficiency response process to assist medtech teams in these high-stakes holds. Learn how reviewers review cyber security documentation, where evidence gaps create a hold, and how to create a full response that allows you to get back on track for review.

If you have received an active FDA deficiency letter or are about to submit a letter to avoid another hold, this session is for you to provide regulatory and engineering teams with actionable clarity.

What You Will Learn

This session offers a behind-the-scenes look at FDA reviewers’ interpretation of medical device cybersecurity documentation and tips for addressing the reviewer’s comments on the first pass.

You will learn:

• Understanding the FDA 510(k) Review Flow: Knowing what happens to your submission in the FDA 510(k) Review Process, from Acceptance to Substantive Review and how it influences your timeline.
• What Happens After Submission: Important decision steps at which submissions are held, and how the review clock works.
• RTA Holds vs. AI Requests: How Failing the threshold completeness screen vs. pausing the scientific review are different.
• Common Cybersecurity Deficiency Triggers: Why missing 524B elements, eSTAR attachment errors, and disconnected security artifacts lead to holds.
• What FDA Reviewers Expect to See: The essential cyber security checklist that is expected for design, labelling and quality.
• Understanding and unpacking FDA Comments: The process of understanding and breaking down reviewer comments, uncovering hidden requirements, and using a “Fix vs. Justify” strategy.
• Building a Complete, Reviewer-Friendly Response: The mapping of threats, risks, controls and test evidence into a traceable, audit-ready response package.
• This webinar is hands-on, real-world, and based on FDA premarket guidance and submissions.

Who Should Attend

This webinar is designed to address the unique needs of the Regulatory Affairs (RA) professionals, Quality Assurance (QA) leads, Medical Device Founders, Chief Technology Officers (CTOs), Product Security Officers (PSOs), and Submission Owners working on 510(k) clearances.

Quick Submission Readiness Check (optional)

• Confirm whether your device meets the Section 524B “cyber device” criteria before filing.
• Check whether the threat model, security architecture and SBOM align directly with the implementation of controls.
• Properly substantiate with hard evidence from penetration testing and vulnerability assessment all security controls claimed.
• Ensure that eSTAR cybersecurity fields line up exactly with and reference the attached documents.