FDA Part 11 Redirection and Guidance Notice

FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also:

  • officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide
  • formally announces FDA’s intent to reexamine its approach to Part 11, its recognition of serious issues regarding this rule and its impact
  • formally announces FDA’s intent to exercise enforcement discretion with respect to the validation, audit trail, record retention, and record copying requirements of part 11 and to narrow the scope of what qualifies as a regulated electronic record.

These changes can significantly reduce the costs for industry and reduce barriers to further automation.

The full notice is at the link provided and the guidance in a related item on this site (in the news section and in the Part 11 portion of the library.

Part11-cd0314

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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.

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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.

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Next public offering: March 7 & 28, 2024

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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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