For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

Pilot Clinical Investigation: (i) Pilot clinical investigation is defined as those cl ...

(i) for medical devices intended to emit ionizing radiation, information on radiation ...

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...

(b) the intended user (lay person or professional); (c) a general description of the ...

INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed cons ...

(1) "clinical investigation" means the systematic study of an investigational medical ...

7.3.3 Design and development outputs: The outputs of design and development shall be ...