Boston Chapter Virtual Event: FDA’s Latest Revisions to Premarket Cybersecurity Guidance and Common

This is part of the RAPS Boston Navigating the MedTech Digital Health Landscape Series.

Presentation will focus on how Section II of the draft guidance "Select Updates for Premarket Cybersecurity Guidance: Section 524B of the FD&C Act" (Select Update) was finalized and incorporated as Section VII (Cyber Devices) in the June 2025 FDA Premarket Cybersecurity Guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”.  Presentation will cover key aspects of Section VII (Cyber Devices) including interpretation of key terms, what to provide in premarket submissions for each 524B requirement, what to provide in premarket submissions for modifications to existing devices and FDA’s interpretation of how Section 524B of FD&C Act fits into existing regulatory submission criteria. Presentation will also cover top 3 common issues seen with cyber documentation provided in premarket submissions for cyber devices.

Registration Fees & Deadlines

Member: $10 | Nonmember: $35

Speakers: 

Justin Post
Policy Analyst (Cybersecurity)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Office of Product Evaluation and Quality (OPEQ)
Immediate Office (IO) – Digital Health

Justin Post is currently a Policy Analyst (Cybersecurity) in the Immediate Office – Digital Health within CDRH’s OPEQ. The Immediate Office – Digital Health contributes to FDA’s digital health policy and to digital health related programs and activities. It also provides leadership and support to OPEQ staff with premarket and postmarket reviews in alignment with FDA guidance documents with digital health content. As part of the Immediate Office – Digital Health, Justin is primarily focused on premarket and postmarket cybersecurity policy development and implementation across OPEQ’s Office of Health Technology (OHT) 1 through 8.\

Nastassia Tamari
Division Director, Medical Device Cybersecurity
Division of Medical Device Cybersecurity (DMDC)
Office of Readiness and Response (ORR)
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration

Nastassia Tamari is the Division Director for Medical Device Cybersecurity within the Division of Medical Device Cybersecurity (DMDC), housed within the Office of Readiness and Response (ORR) in the Office of Strategic Partnerships and Technology Innovation (OST) in FDA CDRH. The Division of Medical Device Cybersecurity provides leadership and strategic direction for medical device cybersecurity policy. As part of DMDC, she leads a team which develops policy related to medical device cybersecurity to advance national preparedness and responds to cybersecurity vulnerabilities and incidents involving medical devices. She spent more than a decade at a private medical device manufacture supporting the creation a product security program, leading the security operations team for enterprise, product, and manufacturing, and finally leading a global team in strategic regulatory alignment. She earned a B.A. in Communication from San Diego State University and completed graduate work at Boston University earning an M.S. in Journalism.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

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