Cuestionario vinculado a una guía · Medio Nivel

Cuestionario sobre la regulación de los dispositivos médicos de IA de la FDA

Prueba las vías 510(k), De Novo y PMA, los planes de control de cambios predeterminados para las actualizaciones de IA y cómo se aplican las normas de la Ley MDR y de IA de la UE a los dispositivos de IA.

Rutas de guía relacionadasRegulación de la FDA sobre dispositivos médicos de IA
Pregunta 1 de 8

What must a manufacturer show to obtain 510(k) clearance?

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Las respuestas y explicaciones aparecen a medida que realiza el cuestionario.

  1. What must a manufacturer show to obtain 510(k) clearance?
    • That the device is substantially equivalent to a legally marketed predicate device
    • That the device has completed three phases of randomized clinical trials
    • That the device has no predicate and is low to moderate risk
    • That the device learns continuously from patient data
  2. The FDA authorized IDx-DR, an autonomous AI for diabetic retinopathy, in 2018. Which pathway did it use, and why?
    • PMA, because every diagnostic AI is Class III
    • 510(k), because many retinal cameras already existed
    • De Novo, because it was novel and had no suitable predicate
    • It needed no authorization under the Cures Act exclusion
  3. What does a predetermined change control plan (PCCP) allow?
    • Selling a device before the FDA has reviewed it
    • Making specified, pre-validated modifications to an AI device without a new submission for each one
    • Letting a model rewrite its own intended use in the field
    • Skipping postmarket monitoring
  4. Which three parts make up a PCCP?
    • Predicate list, clinical trial, and labeling
    • Risk class, user fee, and establishment registration
    • Algorithm source code, training data, and patent filings
    • Description of modifications, modification protocol, and impact assessment
  5. Which statement about most FDA-authorized AI devices is accurate?
    • They are generally locked models that change only through controlled updates
    • They retrain themselves automatically on every patient they see
    • They are all Class III devices approved through PMA
    • They are mostly used in dermatology
  6. Under the 21st Century Cures Act, which kind of software can fall outside the definition of a device?
    • Software that analyzes medical images to detect tumors
    • Any software sold by a hospital
    • Clinical decision support that shows clinicians the basis for its recommendations so they can review them independently
    • Any software that uses machine learning
  7. Under the EU Medical Device Regulation, which rule classifies software, and where does most diagnostic software end up?
    • Rule 1, which puts it in Class I
    • Rule 11, which puts most of it in Class IIa or higher
    • Annex XVI, which exempts it
    • Rule 22, which places all software in Class III
  8. Why do reviewers ask for AI device performance broken down by subgroup and acquisition equipment?
    • To calculate user fees
    • To choose a predicate device
    • To decide whether the device is Class I
    • Because models can fail when patient populations or equipment such as scanner vendors differ from the training data