A Predetermined Change Control Plan lets you make planned changes after clearance without a new submission. We write the cybersecurity content of your PCCP: the security side of each planned change, the testing that proves it, and the tie-in to your postmarket plan and SBOM.
The short answer
A Predetermined Change Control Plan (PCCP) lets the FDA approve planned device changes up front. The cybersecurity work covers how each planned change affects the attack surface, which security tests run before release and what counts as a pass, how security risk is assessed in the Impact Assessment, and how the plan fits with the postmarket cybersecurity plan and SBOM updates.
275+ devices supported. Built against the FDA's December 2024 PCCP guidance and February 2026 premarket guidance.
Most PCCPs are written by regulatory and engineering teams. The security content is often an afterthought, and reviewers notice.
Every planned change can alter the attack surface. If the Impact Assessment never says how, the reviewer asks, and the plan may be narrowed or rejected.
A Modification Protocol that says changes will be "security tested" gives the reviewer nothing to check. The plan needs named tests, pass criteria and when each test runs.
A PCCP has to fit with your postmarket cybersecurity plan and SBOM updates. When the two documents disagree about how a fix ships, the gap shows up in review.
Postmarket monitoring guideWe own the security content. Your regulatory team keeps ownership of the plan as a whole.
We review your device, the changes you plan to make and your current threat model and hazard analysis, then send a fixed-fee quote.
A project manager runs the engagement over Slack and secure file sharing. You share the draft PCCP, architecture, SBOM and risk file.
We write the security sections of the plan and review the whole draft for security gaps, working alongside your regulatory team.
If the FDA asks questions about the security content, we help you answer them.
Every pccp cybersecurity services engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every engagement is a fixed fee, quoted after a free scoping call. No hourly billing.
Fixed fee after scoping
You have a draft PCCP and want the security content checked before submission.
Fixed fee after scoping
You need the security sections written, alongside your regulatory team.
Fixed fee after scoping
You need the whole premarket cybersecurity package with a PCCP included.
The FDA decides whether to authorize a PCCP. We make sure the security content is complete and clearly written.
A Predetermined Change Control Plan lets you make planned changes after clearance without a new submission. We write the cybersecurity content of your PCCP: the security side of each planned change, the testing that proves it, and the tie-in to your postmarket plan and SBOM.
