Pre-determined Change Control (PCCP)
Overview
The PCCP discussed in FDA’s 2019 AI Discussion Paper and 2021 AI Action Plan enables software developers to describe anticipated modifications and the approach to their implementation in a premarket submission and implement those modifications post-market after clearance or approval without the need for further premarket review.
New FDA Draft Guidance
FDA releases new Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff.
Benefits
Quicker implementation of software changes and improved patient access.
Deliverables
Best practices framework detailing different PCCP examples from various medical device organizations.
Project Leadership
Pat Baird
Sr. Regulatory Specialist
Tealman Bjoraker, MS
Director, Regulatory Affairs, Enabling Technologies, Cranial & Spinal Technologies
Join us!
To learn more, please contact MDIC staff at DHT@mdic.org.
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