Subpart B--Labeling Requirements for Unique Device Identification
(a) A labeler may submit a request for an exception from or alternative to the requirement of
(1) Identify the device or devices that would be subject to the exception or alternative;
(2) Identify the provisions of this subpart that are the subject of the request for an exception or alternative;
(3) If requesting an exception, explain why you believe the requirements of this subpart are not technologically feasible;
(4) If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative;
(5) Provide, if known, the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative; and
(6) Provide other requested information that the Center Director needs to clarify the scope and effects of the requested exception or alternative.
(b) A written request for an exception or alternative must be submitted by sending it:
(1) If the device is regulated by the
(2) In all other cases, by email to: firstname.lastname@example.org, or by correspondence to: UDI Regulatory Policy Support,
(c) The Center Director may grant an exception or alternative, either in response to a request or on his or her own initiative, if the Center Director determines that an exception is appropriate because the requirements of this subpart are not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or would better ensure the safety or effectiveness of the device that would be subject to the alternative. If we grant an exception or alternative, we may include any safeguards or conditions deemed appropriate to ensure the adequate identification of the device through its distribution and use. Any labeler may make use of an exception or alternative granted under this section, provided that such use satisfies all safeguards or conditions that are part of the exception or alternative.
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