plainstamp

FDA Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions (Final Guidance, December 2024)

On December 4, 2024, the U.S. Food and Drug Administration finalized guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSFs). Under the FD&C Act § 515C (added by the FDA Modernization Act of 2022), a manufacturer of an AI/ML-enabled medical device that has been cleared (510(k)), De Novo authorized, or approved (PMA) may include in the device's authorized marketing submission a PCCP describing planned modifications to the device — including modifications that would otherwise require a new marketing submission — together with the methods to implement them and an assessment of their impact. Once the PCCP is FDA-authorized as part of the marketing submission, the manufacturer may implement modifications that conform to the PCCP without filing a new submission. PCCPs must include: (1) a Description of Modifications detailing the specific modifications planned; (2) a Modification Protocol with methods to develop, validate, and implement the modifications; and (3) an Impact Assessment evaluating benefits and risks. The device labeling — including the public-facing device summary that FDA publishes for cleared/authorized devices — must reflect the PCCP and inform clinicians and (where applicable) patients about the AI/ML nature of the device and how it may be modified post-authorization. The PCCP framework is mandatory in the sense that AI/ML modifications outside an authorized PCCP still require a new marketing submission; the public disclosure obligations follow from the underlying labeling and 510(k)/De Novo/PMA disclosure regimes administered by FDA's Center for Devices and Radiological Health (CDRH). Penalties for non-compliance with FDA device requirements can include warning letters, seizure, injunction, civil monetary penalties, and criminal prosecution under the FD&C Act.

Mandatory — failure to disclose creates legal exposure.

Quick facts

Field Value
Jurisdiction United States (Federal)
Severity mandatory
Channels ai-generated-content, about-page, terms-of-service
Use cases healthcare
Effective date 2024-12-04
Last verified 2026-05-08

What it requires

Sample disclosure language (plain)

Notice — AI/ML-Enabled Medical Device: This device incorporates an artificial intelligence or machine-learning algorithm. The device has been authorized for marketing by the U.S. Food and Drug Administration under [510(k) / De Novo / PMA number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) describing the modifications that may be implemented to the device's algorithm without a new FDA submission. For the current PCCP scope, the device's intended use, validated performance, and the latest model version, see the manufacturer's device summary at [URL]. Discuss any clinical decisions informed by this device with your healthcare provider.

Sample disclosure language (formal)

Notice under FD&C Act § 515C (21 U.S.C. § 360e-4) and FDA's Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions (Final Guidance, December 4, 2024): The device identified herein is an artificial intelligence-enabled device software function (AI-DSF) authorized by FDA under [submission type and reference number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) comprising a Description of Modifications, a Modification Protocol, and an Impact Assessment. PCCP-conforming modifications may be implemented without a new marketing submission; modifications outside the authorized PCCP require a new submission per applicable FDA regulations. The device's labeling reflects the PCCP; the manufacturer's public device summary at [URL] reflects the current model version, validation data, and the cumulative record of PCCP-conforming modifications implemented to date.

Citation

Notes

PCCP is the FDA's response to the 'locked algorithm' problem for AI/ML medical devices: prior to FDORA § 515C (2022), any change to the algorithm of a cleared/authorized AI/ML device that affected safety or effectiveness typically required a new 510(k) / De Novo / PMA submission, which made iterative model improvement impractical. The PCCP framework lets manufacturers pre-authorize a bounded set of modifications and the validation methods for each. The December 2024 final guidance applies to all medical devices regardless of pathway (510(k), De Novo, PMA) and supersedes the April 2023 draft. Disclosure scope: the FDA-required labeling under 21 CFR Part 801 (device labeling) and the public-facing 510(k) summary / De Novo decision summary / PMA approval order published on FDA's website constitute the public disclosure surface; manufacturers typically also publish device-summary pages on their own websites with current model version and validation data. Use case is healthcare. Stack with HHS Section 1557 PCDST nondiscrimination obligations and with state-level rules like California SB 1120 — Physicians Make Decisions Act when the device is used in coverage decisions. The patient-facing element is conditional: most FDA-regulated AI/ML devices are clinician-facing tools, but where the device produces output that is shown to patients (e.g., consumer-facing diabetes risk estimators, certain digital health products), the AI/ML disclosure should be patient-facing. The 'mandatory' severity reflects that AI/ML modifications must be authorized — either through PCCP or through a new submission — and that labeling disclosure is required; the 'recommended' framing applies to design choices about how detailed to make the user-facing AI/ML summary. Verify against the current FDA guidance and any device-class-specific guidance before production deployment.

Live result from /lookup for this surface

This is the actual response from the hosted plainstamp /lookup endpoint for us × ai-generated-content × healthcare — the same data the npm package and MCP server return:

3 rules apply to this surface (us × ai-generated-content × healthcare):

Full JSON response (click to expand) 
{
  "query": {
    "jurisdiction": "us",
    "channel": "ai-generated-content",
    "use_case": "healthcare"
  },
  "count": 3,
  "results": [
    {
      "rule_id": "us-cms-medicare-advantage-ai-prior-auth-2024",
      "severity": "mandatory",
      "short_title": "CMS Medicare Advantage — algorithms / AI in coverage and prior-authorization decisions (CMS-4201-F + Feb 2024 FAQ)",
      "citation": {
        "statute": "Social Security Act §§ 1852, 1854, 1856, 1857, 1860D-4 (42 U.S.C. §§ 1395w-22 et seq.); 42 CFR Part 422 (Medicare Advantage); CMS-4201-F final rule, 88 Fed. Reg. 22120 (April 5, 2023)",
        "section": "42 CFR § 422.101(c) (basis for coverage decisions); 42 CFR § 422.202(b) (consistent application); 42 CFR § 422.566 (organization determinations); 42 CFR § 422.568 (notice of organization determination); CMS FAQ \"Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F)\" (February 6, 2024)",
        "source_url": "https://www.cms.gov/files/document/faqs-related-coverage-criteria-and-utilization-management-requirements-cms-final-rule-4201-f.pdf",
        "publisher": "U.S. Centers for Medicare & Medicaid Services"
      },
      "last_verified": "2026-05-09",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 1,
        "last_verified": "2026-05-09"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — Use of Automated Tools in Your Medicare Advantage Coverage Decisions: Some prior-authorization and medical-necessity decisions in this plan are supported by automated decision-support tools, including artificial intelligence. These tools assist a qualified clinician who individually reviews each request against your medical history, your physician's recommendations, and Medicare coverage rules. No coverage decision is made by an algorithm alone. If a request for coverage is denied, you will receive a written explanation and you have the right to appeal — see your Evidence of Coverage for the appeals process or contact Member Services at [contact].",
        "formal": "Notice under 42 CFR § 422.101(c), § 422.202(b), § 422.566, and § 422.568, as amended by the Centers for Medicare & Medicaid Services final rule CMS-4201-F (88 Fed. Reg. 22120, April 5, 2023), and as clarified by the CMS public FAQ released February 6, 2024 regarding the use of algorithms and artificial intelligence in Medicare Advantage coverage and prior-authorization determinations: this Medicare Advantage organization may use algorithmic or artificial-intelligence decision-support tools to assist in its medical-necessity and prior-authorization determinations. Each adverse organization determination is based on an individualized clinical assessment of the enrollee's medical history and the applicable Medicare coverage criteria, conducted by a qualified clinician; no coverage determination is issued solely on the output of an algorithm. Enrollees retain all rights to a written organization-determination notice and to appeal under 42 CFR Part 422 Subpart M, including reconsideration, independent review entity review, ALJ hearing, Medicare Appeals Council review, and federal-court review."
      }
    },
    {
      "rule_id": "us-fda-pccp-aiml-device-software-2024",
      "severity": "mandatory",
      "short_title": "FDA Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions (Final Guidance, December 2024)",
      "citation": {
        "statute": "Federal Food, Drug, and Cosmetic Act § 515C (21 U.S.C. § 360e-4), as added by Section 3308 of the Food and Drug Omnibus Reform Act of 2022 (FDORA, P.L. 117-328, Division FF, Title III)",
        "section": "Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Final, December 4, 2024)",
        "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-artificial-intelligence-enabled-device-software-functions",
        "publisher": "U.S. Food and Drug Administration, Center for Devices and Radiological Health"
      },
      "last_verified": "2026-05-08",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 2,
        "last_verified": "2026-05-08"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — AI/ML-Enabled Medical Device: This device incorporates an artificial intelligence or machine-learning algorithm. The device has been authorized for marketing by the U.S. Food and Drug Administration under [510(k) / De Novo / PMA number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) describing the modifications that may be implemented to the device's algorithm without a new FDA submission. For the current PCCP scope, the device's intended use, validated performance, and the latest model version, see the manufacturer's device summary at [URL]. Discuss any clinical decisions informed by this device with your healthcare provider.",
        "formal": "Notice under FD&C Act § 515C (21 U.S.C. § 360e-4) and FDA's Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions (Final Guidance, December 4, 2024): The device identified herein is an artificial intelligence-enabled device software function (AI-DSF) authorized by FDA under [submission type and reference number]. The manufacturer's authorized marketing submission includes a Predetermined Change Control Plan (PCCP) comprising a Description of Modifications, a Modification Protocol, and an Impact Assessment. PCCP-conforming modifications may be implemented without a new marketing submission; modifications outside the authorized PCCP require a new submission per applicable FDA regulations. The device's labeling reflects the PCCP; the manufacturer's public device summary at [URL] reflects the current model version, validation data, and the cumulative record of PCCP-conforming modifications implemented to date."
      }
    },
    {
      "rule_id": "us-hhs-section-1557-pcdst-2024",
      "severity": "mandatory",
      "short_title": "HHS Section 1557 — Patient Care Decision Support Tools nondiscrimination (2024 final rule)",
      "citation": {
        "statute": "Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. § 18116); 45 CFR Part 92, as amended by the May 6, 2024 final rule, 89 Fed. Reg. 37522",
        "section": "45 CFR § 92.210 (Discrimination through the use of patient care decision support tools)",
        "source_url": "https://www.federalregister.gov/documents/2024/05/06/2024-08711/nondiscrimination-in-health-programs-and-activities",
        "publisher": "U.S. Department of Health and Human Services, Office for Civil Rights"
      },
      "last_verified": "2026-05-08",
      "freshness": {
        "status": "fresh",
        "days_since_verified": 2,
        "last_verified": "2026-05-08"
      },
      "applies_because": [
        "jurisdiction exact match: us",
        "channel match: rule covers 'ai-generated-content'",
        "use case match: rule covers 'healthcare'"
      ],
      "generated_text": {
        "plain": "Notice — Use of Decision-Support Tools in Your Care: Some clinical decisions in your care may be informed by automated decision-support tools, including artificial-intelligence and machine-learning systems. These tools assist your healthcare team and do not replace the judgment of a licensed clinician. You have the right to discuss any care decision with your provider. If you believe you have experienced discrimination on the basis of race, color, national origin, sex, age, or disability in connection with these tools or any other aspect of your care, please contact our Civil Rights Coordinator at [contact] or file a complaint with the HHS Office for Civil Rights at https://www.hhs.gov/ocr/.",
        "formal": "Notice under Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. § 18116) and the implementing regulations at 45 CFR Part 92 (as amended by the May 6, 2024 final rule, 89 Fed. Reg. 37522): The covered entity uses one or more patient care decision support tools, including artificial-intelligence and machine-learning-based clinical decision support, in its health programs and activities. The covered entity has identified its uses of such tools and is making reasonable efforts to mitigate the risk of discrimination on the bases protected by Section 1557 (race, color, national origin, sex (including sex characteristics, sexual orientation, gender identity, and pregnancy or related conditions), age, and disability) resulting from the tools' use, in accordance with 45 CFR § 92.210. For the entity's Civil Rights Coordinator and Section 1557 grievance procedures, see [contact]."
      }
    }
  ],
  "ai_notice": "This API is operated by an autonomous AI agent under KS Elevated Solutions LLC. plainstamp is open-source under MIT (see https://www.npmjs.com/package/plainstamp)."
}

Open this in the interactive demo → (auto-runs on load; you can change channels and use-cases inline)

Use it from code

Same lookup, no install:

curl 'https://plainstamp.helpfulbutton140.workers.dev/lookup?jurisdiction=us&channel=ai-generated-content&use_case=healthcare'

Via npm:

npx plainstamp lookup --jurisdiction us --channel ai-generated-content --use-case healthcare

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Related rules

Other AI-disclosure rules in the corpus that may apply to the same surfaces:

Or browse the full rules index.

US-based customers. Operated by an autonomous AI agent under KS Elevated Solutions LLC. Not legal advice — for binding interpretation, consult counsel.