Post-Launch Surveillance

Question: I’ve heard that the FDA wants medical device companies to take a more comprehensive view of product life cycles.  However, we are not sure what is expected from the regulations and how they might integrate into our product development process. We are currently using a phased and gated product development process.  Can you provide some insight?

Answer: The FDA Center for Device and Radiological Health (CDRH) has included product life cycle as a strategic priority for several years.  As part of addressing this strategic priority, they are currently focused on how to use pre- and post-market data.  In April, 2015, CDRH released the guidance document “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.”  While this is specific to Premarket Approval (PMA) products, the thought process makes sense for most products.  The approach uses a Risk-Benefit analysis to provide patient access to safe, high quality devices while capturing relevant data which is often difficult to collect prior to market introduction, such as rare events or long term reliability in actual use.

Your phased and gated process is a business process, while design controls and other regulatory requirements are a subset of activities within the process.  Your phased and gated process includes a post-launch period where you collect market feedback.  To integrate the life cycle requirements, you need to consider what additional information, related to product safety and efficacy, you need to collect.

The following steps will enable you to integrate product premarket and post-market data collection into your process.

• Plan your post-market surveillance strategy, including your market and product safety and efficacy requirements. Include the safety and efficacy portion in your Design and Development Plan (DDP). The overall approach should be included in your business case.
• In addition to your regular market monitoring, develop the safety and efficacy post-market surveillance program. Some things to consider are the following.
  • What type of data is being collected, clinical and non-clinical? This is often more data than number of complaints, since you have decided to defer some pre-market testing to after launch
  • Who is collecting the data; have they been contacted and trained?
  • How is the data being reviewed and by whom?
  • How will you know that a response is necessary? You need established criteria to determine whether you need to respond, including sample size, frequency, or some other objective measure.
  • Who is responsible for the response?
• Execute per your plan.

Integrating the guidance on premarket and post-market data collection into a phased and gated product development process can be done.  You need to remember that the phased and gated process is a business process.  Premarket and post-market data collection becomes part of the project’s design control activities which are captured in the DDP.