§ 230.100. FDA review of submissions.
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/us/cfr/t21/s§ 230.100·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)In reviewing a submission pursuant to § 230.50, FDA will consider information provided with the submission along with any other available, relevant information of which FDA becomes aware, including information obtained from State or Federal officials, FDA inspection reports, or any other source.
(b)FDA will deny a submission if FDA finds that:
(1)The medical gas that is the subject of the submission is not a designated medical gas;
(2)The submission does not contain the required information or otherwise appears to lack sufficient information to determine that the medical gas is a designated medical gas;
(3)The applicant's methods, facilities, and controls used for the manufacture, processing, and handling of the designated medical gas, as applicable, are not adequate to ensure its safety, identity, strength, quality, and purity; or
(4)Denying the request is otherwise necessary to protect the public health.
(c)Within 60 calendar days of filing of a submission, FDA may contact the applicant to request additional information regarding the submission if it determines that required information is not included in the submission, that FDA needs such information to determine whether the medical gas is a designated medical gas, or that FDA determines such information is necessary to protect the public health. Upon receipt of an amendment to a pending certification request, this 60-day review period will restart. If FDA is not able to contact the applicant to obtain and evaluate the information within the 60-day review period, FDA may find that the submission lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission. If FDA is able to contact the applicant but is not provided with the additional information requested within the 60-day review period, FDA may find that the request lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission.
(d)Within 60 calendar days of filing of a submission, if FDA makes one of the findings described in paragraph
(b)of this section, FDA will notify the applicant in writing that the submission is denied and provide the basis for FDA's determination.