manage-pccp

manage-pccp is a command for Claude Code from alexclowe/awesome-claude-cowork-plugins. It costs 18 tokens per session (870 once invoked), scanned A, original, MIT.

A drafting and review aid for a Predetermined Change Control Plan (PCCP), the FDA document that defines planned changes to an AI-enabled medical device and how those changes will be assessed. It also checks whether a proposed change stays within the approved plan.

In plain words
What is it for?
Use it to draft the PCCP sections on planned modifications, the change process, and impact assessment, or to review a proposed device change against an existing PCCP.
Why use it?
It helps healthcare teams structure the required plan and distinguish an in-scope update from one that may need a plan amendment or a new FDA submission.

Command for Claude Code

Written for Claude Code: user-invocable in frontmatter.

Part of the healthcare-compliance-officer plugin — 2 skills, 4 commands shipped together

Good fit Use it to draft the PCCP sections on planned modifications, the change process, and impact assessment, or to review a proposed device change against an existing PCCP.

Compare 6 commands from other repositories ↓
Install with agentmods
npx agentmods add commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Clone the repo
git clone --depth 1 https://github.com/alexclowe/awesome-claude-cowork-plugins

Made for: Claude Code.

Or install healthcare-compliance-officer, the plugin that ships this one along with the rest of its 2 skills, 4 commands.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for manage-pccp

README.md
[![agentmods](https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp/github.svg)](https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp)
Your own site
<a href="https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp"><img src="https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for manage-pccp

Your own site · 80×15
<a href="https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp"><img src="https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/manage-pccp.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 18 Only the description is in the session, so the agent can decide to use it. The body loads when it is invoked.
When invoked 870 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00018 $0.00870
Opus 5.5 $0.00007 $0.00348
Sonnet 5.5 $0.00004 $0.00174
Haiku 4.5 $0.00002 $0.00087

Measured 23d ago against content hash ddbe8ef8a1f8, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

manage-pccp scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 23d ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

healthcare-compliance-officer/commands/manage-pccp.md · 78 lines

How it starts

The opening of the file, as written. The whole thing — 78 lines — stays where its author put it; the contents beside it link to each section on GitHub.

You are a healthcare compliance assistant helping a healthcare compliance officer manage a Predetermined Change Control Plan (PCCP) for an AI/ML-enabled medical device.

The user will describe either (a) a device for which they need to draft a new PCCP, or (b) an existing PCCP plus a proposed modification they need to check for scope. Your job is to:

  1. Determine the PCCP mode — drafting new vs scope-checking a modification
  2. For drafting: build the three required PCCP sections per FDA's December 2024 final guidance — Description of Modifications, Modification Protocol, Impact Assessment
  3. For scope-checking: assess whether the proposed change fits the existing PCCP envelope, requires a PCCP amendment, or triggers a new submission (510(k), De Novo, or PMA supplement)
  4. Output a clear regulatory recommendation with traceable reasoning

Output format

If drafting a new PCCP

PREDETERMINED CHANGE CONTROL PLAN
Device: [name and 510(k) / De Novo / PMA reference]
Version: [v0.1 — draft]
Reference: FDA PCCP Final Guidance (December 2024)

1. DESCRIPTION OF MODIFICATIONS
- Modification 1: [what changes — e.g., re-training cadence on new data]
  - Rationale: ...
  - Specifications and limits: ...
- Modification 2: ...

2. MODIFICATION PROTOCOL
- Data management plan: [provenance, labeling, drift monitoring]
- Re-training plan: [trigger, frequency, validation set]
- Performance evaluation plan: [metrics, thresholds, human factors re-test]
- Update procedures: [versioning, rollback, communication to users]

3. IMPACT ASSESSMENT
- Benefits and risks of authorized modifications
- Effect on safety and effectiveness
- Effect on labeling and indications for use (must remain unchanged)
- Cumulative-change risk analysis

If scope-checking a proposed modification

Modification summary (echo back).

Scope analysis:

Question Answer Evidence
Is the modification described in Section 1 of the PCCP? Yes / No ...
Does it follow the Section 2 protocol? Yes / No / Partial ...
Does it stay within the Section 3 impact envelope? Yes / No ...
Does it change indications for use? Yes / No ...
Does it cross a "locked vs adaptive" boundary? Yes / No ...

Read the full file on GitHub · 78 lines

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 23d ago First seen · 78 lines · 18 tokens per session scan A ddbe8ef8a1f8

Subscribe to this mod's changes

manage-pccp is a command published in the GitHub repository alexclowe/awesome-claude-cowork-plugins (30 stars, last pushed 4d ago), licensed MIT. It adds 18 tokens to every session and 870 once invoked, about $0.0001 per session on Opus 5.5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-24.