FDA Refuse to Accept RTA Guidance for Premarket Submissions

This webinar clarifies common pitfalls and how to ensure your medical device submissions are accepted.

Naomi Schwartz, Mike Kijewski

About this webinar

What to expect.

In this webinar, MedCrypt CEO Mike Kijewski and FDA expert Naomi Schwartz share their thoughts on the FDA's new Refuse to Accept (RTA) guidance. In March 2023, following the December 2022 Omnibus bill passed by Congress, the FDA released its RTA Cybersecurity guidance. This stipulated that after October 2023, any medical device manufacturer that fails to meet specific cybersecurity rules would have its products rejected by the FDA.

Related resources

Go deeper on the topics from this webinar with Medcrypt analysis and real device programs.

Blog · FDA Cybersecurity Readiness

Legacy Devices and FDA Cybersecurity: What You Need to Know

Introduction: Why This Matters When people talk about “legacy devices,” the conversation often gets muddy. Are we talking about devices that are no longer marketed or supported by…

Read article

Blog · Thought Leadership

Under Pressure: Why Medical Device Manufacturers Should Shift Focus to Cybersecurity Now

Medical device manufacturers (MDMs) are facing a growing push from both regulators and healthcare providers to strengthen the cybersecurity posture of their products. The RunSafe…

Read article

Blog · FDA Cybersecurity Readiness

Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything Webinar

Medical device cybersecurity is evolving rapidly, and regulatory expectations continue to shift as the threat landscape expands. To help medical device manufacturers (MDMs) stay…

Read article

Know where you are in 1 hour.

Run the free check or talk to a human. Either way, you’ll get a clearer view of readiness without a paywall or lengthy sales call.

Check readiness