Refuse to Accept 510(k)

FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version.  As FDA guidance goes, this a short period of time between updates.  It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which includes checking that if standards are referenced in any way their usage is explained, any device-specific guidance was addressed, electrical safety and EMC information is included if relevant.

The term Software is used many times in this guidance including that if software is included in the device the information requested in the FDA “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and the associated Off-the-shelf software guidance (if relevant) is included. If a device does not contain software it must be clearly indicated that it does not.

The full guidance is at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf

Read our earlier posts on this subject FDA Final Revised Refuse to Accept Policy (1/30/18) and FDA Revised 510(k) Refuse to Accept Policy (1/3/13)

 

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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