"AMONG OTHER RELEVANT FACTORS" - sorta missed that little ole "tid bit" of KEY language? Sorta. Further, that is a citation of ONLY 3.1. There's about another 500 pages of "review process/standards" missing there?
For example- something as simple as "the magnitude of the so called "benefit" is a determining criteria. In other words, a "small" benefit may be deemed not worth it by FDA: FDA-
"The magnitude of the benefit(s) – we often assess benefit along a scale or according to specific endpoints or criteria (types of benefits), or by evaluating whether a pre-identified health threshold was achieved. The change in subjects’ condition or clinical management as measured on that scale, or as determined by
an improvement or worsening of the endpoint, is what allows us to determine the magnitude of the benefit in subjects. Variation in the magnitude of the benefit across a population may also be considered. "
A "refection" can come down to something as simple as the FDA saying, "the benefit is small to almost nothing at all, therefor there is no purpose to approve this "new" drug/procedure/device"- seen it happen many, many times.
Other examples:
:In addition to section 513(a), the criteria for establishing safety and effectiveness of a device are set forth
in 21 CFR 860.7. Subsection (b)(1) notes, “In determining the safety and effectiveness of a device … the
Commissioner and the classification panels will consider the following, among other relevant factors …The
probable benefit to health from the use of the device weighed against any probable injury or illness from
such use.” (21 CFR 860.7(b)).
To make this determination, “the agency relies upon only valid scientific evidence.” (21 CFR 860.7(c)(1)).
Valid scientific evidence is defined as “evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-documented case histories conducted by
qualified experts, and reports of significant human experience with a marketed device, from which it can
fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use.” (21 CFR 860.7(c)(2)).
A reasonable assurance of safety occurs when “it can be determined, based upon valid scientific evidence,
that the probable benefits … outweigh any probable risks,” and can be demonstrated by establishing “the
absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses
and conditions of use.” (21 CFR 860.7(d)(1)).
Similarly, a reasonable assurance of effectiveness occurs when “it can be determined, based upon valid
scientific evidence … the use of the device for its intended uses … will provide clinically significant
results.” (21 CFR 860.7(e)(1)). The evidence of which is demonstrated principally through “well-controlled
investigations” (see 21 CFR 860.7(e)(2)), as defined in 21 CFR 860.7(f).
2
Section 513(a)(3)(A) of the FD&C Act."
And that's just a small, smattering of how complex that section is and how many pages and sub-references and other "statutes" and other areas of FDA regulation are involved.
