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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B106. PREMARKET APPROVAL OF MEDICAL DEVICES |
Section 22-B10608. PREMARKET APPROVAL APPLICATION SUPPLEMENTS
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10608.1After the Department's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by the Department before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which the Department, under § 10608.6 of this section, has advised that an alternate submission is permitted or is of a type which, under 21 U.S.C. § 360e(d)(6)(A) and § 10608.7, do not require a PMA supplement under this paragraph. While the burden for determining whether a supplement is required is primarily on the PMA holder, changes for which an applicant shall submit a PMA supplement include, but are not limited to, the following types of changes if they affect the safety or effectiveness of the device:
(a) New indications for use of the device;
(b) Labeling changes;
(c) The use of a different facility or establishment to manufacture, process, or package the device;
(d) Changes in sterilization procedures;
(e) Changes in packaging;
(f)Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device; and
(g)Extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that the Department has not approved. If the protocol has been approved, the change shall be reported to the Department under § 10608.2.
10608.2An applicant may make a change in a device after the Department's approval of a PMA for the device without submitting a PMA supplement if the change does not affect the device's safety or effectiveness and the change is reported to the Department in post-approval periodic reports required as a condition to approval of the device (for example, an editorial change in labeling which does not affect the safety or effectiveness of the device).
10608.3All procedures and actions that apply to an application under § 10606 also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change. A summary under 21 C.F.R. § 814.20(b)(3) is required for only a supplement submitted for new indications for use of the device, significant changes in the performance or design specifications, circuits, components, ingredients, principles of operation, or physical layout of the device, or when otherwise required by the Department. The applicant shall submit three copies of a PMA supplement and shall include information relevant to the proposed changes in the device. A PMA supplement shall include a separate section that identifies each change for which approval is being requested and explains the reason for each such change. The applicant shall submit additional copies and additional information if requested by the Department. The time frames for review of, and Department action on, a PMA supplement are the same as those provided in § 10609 for a PMA.
10608.4After the Department approves a PMA, any change described in § 10608.5 of this section to reflect newly acquired information that enhances the safety of the device or the safety in the use of the device may be placed into effect by the applicant prior to the receipt under § 10604 of a written Department order approving the PMA supplement provided that:
(a) The PMA supplement and its mailing cover are plainly marked "Special PMA Supplement -- Changes Being Effected;"
(b)The PMA supplement provides a full explanation of the basis for the changes;
(c)The applicant has received acknowledgement from the Department of receipt of the supplement; and
(d)The PMA supplement specifically identifies the date that such changes are being effected.
10608.5The following changes are permitted by § 10608.4:
(a) Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association;
(b) Labeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device;
(c)Labeling changes that delete misleading, false, or unsupported indications; and
(d)Changes in quality controls or manufacturing process that add a new specification or test method, or otherwise provide additional assurance of purity, identity, strength, or reliability of the device.
10608.6The Department will identify a change to a device for which an applicant has an approved PMA and for which a PMA supplement under § 10608.1 is not required. The Department will identify such a change in an advisory opinion under 21 C.F.R. § 10.85, if the change applies to a generic type of device, or in correspondence to the applicant, if the change applies only to the applicant's device. The Department will require that a change for which a PMA supplement under § 10608 is not required be reported to DOH in:
(a) A periodic report under § 10617; or
(b) A thirty (30)-day PMA supplement.
10608.7The Department will identify, in the advisory opinion or correspondence, the type of information that is to be included in the report or thirty (30)-day PMA supplement. If the change is required to be reported to the Department in a periodic report, the change may be made before it is reported to the Department. If the change is required to be reported in a thirty (30)-day PMA supplement, the change may be made thirty (30) days after DOH files the thirty (30)-day PMA supplement unless the Department requires the PMA holder to provide additional information, informs the PMA holder that the supplement is not approvable, or disapproves the supplement. The thirty (30)-day PMA supplement shall follow the instructions in the correspondence or advisory opinion. Any thirty (30)-day PMA supplement that does not meet the requirements of the correspondence or advisory opinion will not be filed and, therefore, will not be deemed approved thirty (30) days after receipt.
10608.8Under 21 U.S.C. § 360e(d) of the act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement his section and are eligible to be the subject of a thirty (30) day notice. A thirty (30) day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of Chapter 107 of this subtitle. The manufacturer may distribute the device thirty (30) days after the date on which DOH receives the thirty (30) day notice, unless DOH notifies the applicant within thirty (30) days from receipt of the notice that the notice is not adequate. If the notice is not adequate, the Department will inform the applicant in writing that a one hundred thirty five (135) day PMA supplement is needed and shall describe what further information or action is required for acceptance of such change. The number of days under review as a thirty (30) day notice shall be deducted from the one hundred thirty five (135) day PMA supplement review period if the notice meets appropriate content requirements for a PMA supplement.
10608.9The submission and grant of a written request for an exception or alternative under § 10313 or 21 C.F.R. § 809.11 satisfies the requirement in § 10608.1.