WHEN DOES MODIFICATION OF A MEDICAL OR SURGICAL PROCEDURE, DEVICE, OR DRUG BECOME AN EXPERIMENTAL PROCEDURE?
The issue of subtle variations in drugs and devices that have already been approved rising to the level of investigational status is not clearly described in the regulatory literature. What level of modification is required before an original submission of a new drug or device application is required? Decisions regarding the point of transition from an approved entity to an investigational entity are usually individualized for each product. For the physician who modifies a procedure or a device for use in daily practice, the following distinction is important: “When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is experimental in the sense of new, untested, or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determin
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