FREE ON-DEMAND WEBINAR
November 14, 2024

Predetermined Change Control Plans (PCCP): Approving medical device changes before you make them!

Medical device companies make changes to their devices while they are on the market all the time. Until recently, companies had two regulatory options to handle such changes: 1) to notify the FDA of the change usually via a special 510k or PMA Supplement or 2) to not notify the FDA of the change and handle the change internally via the Letter-to-File.

Now there is a new third option: the Predetermined Change Control Plan a.k.a. the PCCP. Originally exclusive to software devices (SaMD), the FDA has now expanded PCCP eligibility to all medical devices. 

When used effectively, a PCCP can offer significant advantages to the manufacturer by getting changes to their devices approved by FDA in advance of making them! But if not used properly, a PCCP can add tremendous burden by increasing the complexity of the submission, the overall cost, and the time to market.

This presentation will use the case study approach to present the PCCP process in an interactive way, including:

• What is a Predetermined Change Control Plan (a.k.a. PCCP) and when should it be used?
• Why consider a PCCP? What are the risks and benefits?
• How early in development should I consider PCCP?
• How does the PCCP process work and what can the manufacturer expect?
• What info should be provided in the PCCP package?
• Are there any disadvantages of having a PCCP?
• What does a successful PCCP include and how do I ensure my PCCP is successful?

Participants will learn best practices to avoid timely and costly mistakes and discover creative ways to use the PCCP program to their advantage! A PCCP is an option that all medical device companies should be aware of and consider prior to making any FDA submission!