Dive Brief:

• The Food and Drug Administration has released draft guidance on medical device predetermined change control plans (PCCPs), which describe the changes companies can make to their devices without filing a new 510(k) or premarket approval supplement.
• Pre-specifying changes could streamline the process of updating devices. The FDA first outlined how a PCCP might work in the context of medical devices that use artificial intelligence or machine learning, but it has also considered the framework for in-vitro diagnostics. 
• The draft, which the FDA published Thursday, covers the information about a PCCP that companies should include in their marketing submissions. The FDA is accepting feedback until Nov. 20.

Dive Insight:

The FDA introduced the term PCCP in 2019 in a proposed regulatory framework for updating software as a medical device based on artificial intelligence or machine learning. The administration has continued to use the term in guidance on specific devices, including it in another AI-focused document and a text on antimicrobial susceptibility tests in 2023.

Congress gave the FDA power to clear or approve PCCPs in a 2022 omnibus spending bill. Genetic testing company 23andMe entered into a PCCP with the FDA one year ago. 

However, the FDA has lacked broader guidance on how PCCPs apply to medical devices in general. The new draft guidance addresses that gap. In the draft, the FDA sets out its PCCP guiding principles and policy, describes the type of modifications eligible for the plans and lists the content to include in filings. 

“A PCCP is part of the device marketing authorization,” the FDA said. “As such, for the PCCP to be authorized with the device, the totality of the information included in a PCCP should enable FDA to assess the reasonable assurance of safety and effectiveness or substantial equivalence of the device.”

The FDA expects PCCPs to be the least burdensome way to modify devices “when used appropriately,” but the plans are optional. The agency said it will take a risk-based approach to reviewing PCCPs that will consider the device’s intended use, technological characteristics, regulatory history and manufacturer. 

PCCP filings “should include specific modifications that the manufacturer intends to make over time that generally would otherwise require a new marketing submission,” the FDA said. The administration does not want companies to list all modifications that they may possibly make. Rather, companies should include “a few, specific modifications that can be verified and validated,” the FDA said. 

The rest of the draft document goes deeper into the specifics of the PCCP submission process, outlining how to identify a proposed plan in a filing for authorization, determine whether a modification may be suitable for predetermination and provide the content the FDA needs to review a proposal.