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Restricted device vs. prescription device

J

Julia1234

#1
Are prescription devices a subset of restricted devices or are they they same thing? If they are not the same, please provide examples to illustrate the difference. Thank you.
 
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Ronen E

Problem Solver
Staff member
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#2
Not the same.
(i) Restricted device means a device for which a requirement restricting sale, distribution, or use has been established by a regulation issued under section 520(e) of the act, by order as a condition of premarket approval under section 515(d)(1)(B)(ii) of the act, or by a performance standard issued in accordance with sections 514(a)(2)(B)(v) and 514(b) of the act.
(21 CFR 807.3)

A Prescription Device (21 CFR 801.109) is a device that
is not safe except under the supervision of a practitioner licensed by law to direct the use of such device
and is labeled and cleared accordingly.
 
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