(a) A labeler may submit a request for an exception from or alternative to the requirement of §801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must:

(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 Center for Biologics Evaluation and Research (CBER), by email to: [email protected] or by correspondence to: Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993.

(2) In all other cases, by email to: [email protected], or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.

(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.

(d) FDA may initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health. Any such exception or alternative will remain in effect only so long as there remains a public health need for the exception or alternative.

(e) The Center Director may rescind an exception or alternative granted under this section if, after providing an opportunity for an informal hearing as defined in section 201(x) of the Federal Food, Drug, and Cosmetic Act and under part 16 of this chapter, the Center Director determines that the exception or alternative no longer satisfies the criteria described in this paragraph (e) or that any safeguard or condition required under this paragraph (e) has not been met.

[78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015; 81 FR 11428, Mar. 4, 2016; 85 FR 18441, Apr. 2, 2020]