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  1. CDRH Transparency

Total Product Life Cycle for Medical Devices

Medical Device Safety is the Foundation for Total Product Life Cycle

The FDA's Medical Device Safety Action Plan outlines a vision for how the FDA can continue to enhance its programs and processes to assure the safety of medical devices throughout their life cycle, to provide for the timely communication and resolution of safety issues, and to advance innovative technologies that are safer, more effective, and that address unmet needs.

A team-based approach to medical device safety and effectiveness for premarket review, postmarket surveillance, and compliance

Historically, the Center for Devices and Radiological Health (CDRH), the center in the FDA that regulates medical devices, was organized largely according to the stage of the product's life cycle —premarket review, postmarket surveillance, and compliance— rather than holistically by the type of product being regulated. Although that organizational structure allowed CDRH employees to become specialized by function, it did not always promote the type of collaboration and communication that is proving essential to the continuously evolving innovation of medical devices. In 2019, CDRH reorganized to promote and allow for collaborative teamwork focused on device oversight throughout the product's life cycle – from device design and development to real-world use of the device.

The Total Product Life Cycle (TPLC) approach promotes and enhances the transparency, efficiency, and agility of the FDA's regulatory oversight by:

  • Making information and expertise-sharing within CDRH easier
  • Compressing the levels of review, and
  • Helping employees develop a longitudinal, integrated, broader, and deeper view of device safety, effectiveness, and quality.

Overall, the TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by taking into account all available information on safety and effectiveness.

Total Product Life Cycle Approach

The TPLC approach:

  • Provides CDRH staff with a holistic view, from device development through commercialization, which helps guide device premarket and postmarket decision-making.
  • Promotes transparency and consistency in medical device premarket and postmarket review activities, which provides predictable and clear expectations to device manufacturers.
  • Combines premarket and postmarket activities into the same team, which helps the FDA respond to safety issues in a timely way.
  • Ensures transparency on device safety and performance throughout the device's life cycle, and allows CDRH to provide excellent internal and external customer service.
  • Informs the FDA's postmarket and compliance decisions by leveraging knowledge from premarket data.
  • Helps the FDA make better informed premarket decisions by leveraging knowledge from postmarket data and compliance activities.

Total Product Life Cycle Database

The Total Product Life Cycle Database integrates premarket and postmarket data about medical devices. It also:

You can search the TPLC database by device name or procode to receive a full report about a particular product line.

In its current form, the TPLC database provides data by procode, or generic category of device, and not by individual submission or brand name.


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