Health Canada is revising its guidance issued in 1999 on investigational testing authorizations for medical devices.
The guidance is intended to aid device manufacturers and importers in the submission process for ITA applications to conduct investigational testing of a Class II, III or IV device, and provide details on their responsibilities when testing Class I devices.
The previously released guidance is “no longer adequate and lacks clear and consistent guidance on a number of aspects regarding the preparation of applications for ITAs,” Health Canada said in a new draft guidance, which was prompted by frequent requests for clarification from device manufacturers.
Health Canada intends to only issue an ITA after receiving evidence of approval from a research ethics board (REB) for Class III and Class IV devices, and the authorization will be valid until the device is licensed as long as the REB approval is current.
For Class I devices, obtaining ITAs is not a requirement for a manufacturer or importer to sell a device to an investigator for investigational testing, though these must also receive REB approvals, as well as meet institutional requirements.
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, stages of product development, revisions to an investigational testing protocol, and problem reporting. It does not cover in vitro diagnostics.
If several devices are to be included in an investigational study, separate ITA submissions are required for each device. The guidance also includes detailed examples of the required content for ITA submissions.
Health Canada is encouraging manufacturers and importers to request a pre-ITA application meeting, particularly for novel Class III and Class IV devices and combination products.
The meetings may provide a manufacturer or importer an opportunity to present data relevant to an ITA application and discuss any concerns or issues regarding product development. For the regulator, these meetings may also present opportunities to provide guidance and highlight potential deficiencies or concerns.
Interested parties should submit requests for meetings to the Investigational Testing Division of the Medical Devices Bureau. These should include a synopsis of the proposed study and a list of preliminary questions to be addressed during the meeting. Sponsors should include sufficient information so the regulatory authority can assess the utility of the meeting and identify appropriate staff to attend.
Read the draft guidance here: www.fdanews.com/11-28-17-Canada.pdf.