Latest
  1. Johns Hopkins Bayview tells 3,182 patients an employee put their health data into a public AI tool
  2. China’s AI compute access expected to double in 2027, with US-designed chips about 65 per cent
  3. UK commits £100m to national AI Biosecurity Lab
  4. Moonshot AI releases Kimi K3.1 Pro with 1-million-token context window
  5. Residents in Newport and Cardiff oppose hyperscale datacentres near homes
  6. Study: Grok 4.7 picked Republicans in 92% of forced midterm answers, GPT-6.1 Sol picked Democrats in 97%
  7. Attackers exploiting the PHP flaws hand the break-in to AI agents, Unit 42 says
  8. Elvis Presley’s rightsholders sue Anthropic over training on 274 songs

Latest / Health and life sciences

PolicyHealthUSConfirmed

FDA finalises guidance letting AI device makers pre-authorise planned model updates

See how this story connects

Source: Federal Register notice 2024-28361

The FDA announced final guidance on predetermined change control plans (PCCPs) for AI-enabled device software functions on 4 December 2024. It replaces a draft published in April 2023. A PCCP in a marketing submission describes planned modifications, how they will be developed, validated and implemented, and their impact, so that changes within the plan need no new submission. Section 515C of the FD&C Act, added by the Food and Drug Omnibus Reform Act in December 2022, provides for PCCPs in premarket approval and 510(k) submissions.

Why it matters

Makers of AI medical devices in the US could get future retraining and updates authorised up front and then make changes within the plan without a new FDA submission.

When
4 Dec 2024
ID
WTA-N-2024-0017
Who
FDA
Rules involved

Summary by wheresthe.ai, from Federal Register notice 2024-28361. Checked against the source on 9 Oct 2026.

Read the original at Federal Register notice 2024-28361

Source copy: download the page as saved on 18 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: What happened nextFDA issues draft lifecycle guidance for AI-enabled medical devices

Cite this story

WTA-N-2024-0017: “FDA finalises guidance letting AI device makers pre-authorise planned model updates.” wheresthe.ai, 4 Dec 2024. https://wheresthe.ai/d/us-fda-pccp-final-guidance-2024-12/ (source: Federal Register notice 2024-28361).

Spotted an error? Email [email protected].