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 drafts guidance letting AI device makers pre-approve planned model updates

See how this story connects

Source: U.S. Food and Drug Administration (webinar transcript on the draft)Also reported by Ropes & Gray, DLA Piper, Federal Register (final guidance notice citing 88 FR 19648)

The FDA released draft guidance on 3 April 2023 on predetermined change control plans (PCCPs) for machine-learning-enabled device software functions. A PCCP filed with a 510(k), De Novo or PMA submission describes planned modifications, the protocol for retraining and testing them, and an impact assessment, so changes inside the plan need no new submission. Comments were due by 3 July 2023; the plan rests on authority Congress gave the FDA in the Food and Drug Omnibus Reform Act of December 2022.

Why it matters

Makers of AI medical devices gained a proposed route to update cleared models without a new marketing submission for each change, as long as the change stays within an authorised plan.

When
3 Apr 2023
ID
WTA-N-2023-0052
Who
FDA
Rules involved

Summary by wheresthe.ai, from U.S. Food and Drug Administration and the reporting credited above. Checked against the source on 9 Oct 2026.

Read the original at U.S. Food and Drug Administration

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

Next stop on this Storyline: Led toFDA finalises guidance letting AI device makers pre-authorise planned model updates

Cite this story

WTA-N-2023-0052: “FDA drafts guidance letting AI device makers pre-approve planned model updates.” wheresthe.ai, 3 Apr 2023. https://wheresthe.ai/d/us-fda-draft-pccp-ai-device-guidance-2023-04/ (source: U.S. Food and Drug Administration (webinar transcript on the draft)).

Spotted an error? Email [email protected].