RegDesk Reports on the FDA’s Detailed Policy Draft Guidance for PCCP

RegDesk Reports on the FDA’s Detailed Policy Draft Guidance for PCCP

The Food and Drug Administration (FDA) recently released a detailed policy draft guidance for the Pre-Certification Program Pilot (PCCP). The PCCP is a program designed to streamline the regulatory process for digital health products. The guidance provides a framework for how the FDA will evaluate and assess companies that participate in the program.

The PCCP was launched in 2017 as a pilot program to test a new approach to regulating digital health products. The program is designed to allow companies to bring their products to market faster by pre-certifying them based on their software development practices, rather than evaluating each product individually. The goal of the program is to encourage innovation in the digital health space while still ensuring that products are safe and effective.

The new guidance provides more detail on how the FDA will evaluate companies that participate in the PCCP. The guidance outlines five key elements that the FDA will consider when evaluating a company’s software development practices:

1. Quality System Approach: The FDA will evaluate a company’s quality system approach to software development, including how they manage risk, ensure quality, and maintain documentation.

2. Patient Safety Approach: The FDA will evaluate a company’s approach to patient safety, including how they identify and mitigate risks to patients.

3. Clinical Responsibility Approach: The FDA will evaluate a company’s approach to clinical responsibility, including how they ensure that their products are safe and effective for their intended use.

4. Cybersecurity Approach: The FDA will evaluate a company’s approach to cybersecurity, including how they identify and mitigate cybersecurity risks.

5. Transparency Approach: The FDA will evaluate a company’s approach to transparency, including how they communicate with patients and healthcare providers about their products.

The guidance also provides more detail on how the FDA will evaluate companies that participate in the PCCP. The FDA will use a risk-based approach to evaluate companies, with a focus on companies that are developing products that pose a higher risk to patients. The FDA will also evaluate companies based on their track record of compliance with FDA regulations.

Overall, the new guidance provides more detail on how the FDA will evaluate companies that participate in the PCCP. The guidance is designed to encourage innovation in the digital health space while still ensuring that products are safe and effective. Companies that participate in the PCCP will need to demonstrate that they have robust software development practices and a commitment to patient safety. The FDA will continue to refine the program as it moves forward, with the goal of creating a more streamlined regulatory process for digital health products.

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• Source: https://platohealth.ai/fda-draft-guidance-on-pccp-policy-in-detail-regdesk/