D.C. Mun. Regs. tit. 22, r. 22-B10911
The following are required for changes the in investigational plan:
The requirements in § 10911.1(a) regarding the Department approval of a supplement do not apply to developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered during the course of an investigation.
The requirements in § 10911.1(a) regarding the Department approval of a supplement do not apply to changes to clinical protocols that do not affect:
The definition of credible information shall be as follows:
Changes meeting the criteria in § 10911.2 and 10911.3 that are supported by credible information as defined in Paragraph § 10911.4 may be made without prior Department approval if the sponsor submits a notice of the change to the IDE not later than five (5) working days after making the change. Changes to devices are deemed to occur on the date the device, manufactured incorporating the design or manufacturing change, is distributed to the investigator(s). Changes to a clinical protocol are deemed to occur when a clinical investigator is notified by the sponsor that the change should be implemented in the protocol or, for sponsor-investigator studies, when a sponsor-investigator incorporates the change in the protocol. Such notices shall be identified as a "notice of IDE change."
For a developmental or manufacturing change to the device, the notice shall include a summary of the relevant information gathered during the course of the investigation upon which the change was based; a description of the change to the device or manufacturing process (cross-referenced to the appropriate sections of the original device description or manufacturing process); and, if design controls were used to assess the change, a statement that no new risks were identified by appropriate risk analysis and that the verification and validation testing, as appropriate, demonstrated that the design outputs met the design input requirements. If another method of assessment was used, the notice shall include a summary of the information which served as the credible information supporting the change.
For a protocol change, the notice shall include a description of the change (cross-referenced to the appropriate sections of the original protocol); an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis; and a summary of the information that served as the credible information supporting the sponsor's determination that the change does not affect the rights, safety, or welfare of the subjects.
The requirements of § 10911.1(a) do not apply to minor changes to the purpose of the study, risk analysis, monitoring procedures, labeling, informed consent materials, and IRB information that do not affect:
A sponsor shall submit to the Department a certification of any IRB approval of an investigation or a part of an investigation not included in the IDE application. If the investigation is otherwise unchanged, the supplemental application shall consist of an updating of the information required by § 10907.2 and § 10907.3 and a description of any modifications in the investigational plan required by the IRB as a condition of approval. A certification of IRB approval need not be included in the initial submission of the supplemental application, and such certification is not a re-condition for agency consideration of the application. Nevertheless, a sponsor may not begin a part of an investigation at a facility until the IRB has approved the investigation, the Department has received the certification of IRB approval, and the Department, under § 10910.1, has approved the supplemental application relating to that part of the investigation (see21 C.F.R. § 56.103(a) ).
D.C. Mun. Regs. tit. 22, r. 22-B10911