Guidance on managing applications for medical device licences: Reconsideration process

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• Introduction
• Key steps

Introduction

When a negative decision is issued for a new or amendment medical device licence (MDL) application, the manufacturer may ask for the decision to be reconsidered. This is set out in paragraph 38(3) of the Medical Devices Regulations (regulations).

The reconsideration process provides a mechanism for reopening the decision to ensure it was made fairly and in accordance with the regulations.

During the reconsideration process, you may present and explain your position. However, you can only base your position on information that was available to Health Canada's Medical Devices Directorate (MDD) when the original decision was made.

Independent scientific, medical or regulatory experts will consider your position and make a recommendation to MDD’s Director General or delegate (DG). The DG will let you know if the original decision is upheld, partially amended or fully amended.

Key steps

In this section, we outline the key steps in the reconsideration process. Timelines for MDD are target timelines and while we make every effort to meet these targets, unforeseen delays can occur.

A process map showing the key steps and timelines is included in Appendix B (see Figure 5).

Decisions eligible for reconsideration

You may file a request for reconsideration to the DG following a:

• rejection letter or
• refusal letter

A request for reconsideration should be based on the issues identified in the decision letter. Examples of issues that may lead to a request for reconsideration include:

• applied methodology
• interpretation of available data
• relative weight given to data and its impact on the risk-benefit assessment

Request for reconsideration

You should submit a request for reconsideration within 30 calendar days of receiving the negative decision letter. The request must be filed using the Regulatory Enrolment Process (REP). Learn about the REP for medical devices.

The request for reconsideration should include:

• a copy of the negative decision letter for which the reconsideration is requested and
• your position and rationale for each issue for which you are requesting reconsideration
  • should cross-reference to points in the decision letter and previously submitted information, as applicable

Reconsideration is based only on the information that was contained in the application at the time of the original decision. While you may clarify previously submitted information, you may not reference or include new information in the request for reconsideration. Information that alters the original application (such as new data, studies, labelling or quality management system certificate, or different analyses of existing data) will not be considered.

If you do not file a request for reconsideration or if you withdraw a request, the original negative decision stands.

Screening of the reconsideration request

MDD staff not previously involved in the original decision will screen the request for reconsideration. Within 15 calendar days of its receipt, a letter will be issued to you indicating whether your request is eligible or ineligible for reconsideration, or if it is deficient (for example, missing information or containing new information).

If the request is deficient, you will have an opportunity to address the deficiencies. If it is eligible, the letter of eligibility will identify the reconsideration process pathway that the DG selected (internal review or external panel review).

Reconsideration process pathways

The reconsideration process may involve a review by independent Health Canada experts or, in exceptional circumstances, an external panel of experts. Selection of a reconsideration process pathway is at the sole discretion of the DG . When selecting a pathway, every effort is taken to ensure fairness, impartiality and responsible stewardship of resources. Selection is also based on the type of issues under reconsideration and the availability of expertise within Health Canada.

The target timeframes (period from the date the request for reconsideration is received to the date the reconsideration decision is issued) for the reconsideration process pathways are:

• internal review based on written submissions: 50 calendar days
• internal review based on written submissions and a reconsideration meeting: 85 calendar days
• external panel review based on written submissions and a reconsideration meeting: 140 calendar days

Internal review

The internal reconsideration review staff are identified within 10 calendar days of the date of the letter of eligibility.

To uphold fairness and impartiality, the internal review process pathway provides for an independent review by 1 or more experts within Health Canada who were not involved in the original decision. The staff involved in the original decision (original bureau) may be asked, however, to clarify their decision.

Reconsideration of the original decision may also involve consulting an internal or external expert.

You may choose to have the internal reconsideration review be based on written submissions or written submissions and a reconsideration meeting. You should indicate your preference following receipt of the letter of eligibility.

External panel review

The pathway involving a review by a panel of scientific or medical experts outside of the federal government may be chosen if:

• an internal expert who was not previously involved is not available
• MDD determines that external perspectives are required
• the review involves highly specialized scientific or clinical matters

The DG may consider a request for reconsideration without referring to an external panel if MDD has a recent outside independent expert opinion on the specific issue. Also, issues that concern the submission of false or misleading information are not appropriate for review by an external panel.

Establishment of an external panel

An external panel consists of 3 members:

• 1 member selected by the DG from nominations by the manufacturer
• 1 member selected by the DG from nominations by the original bureau
• 1 member appointed by the DG who will chair the panel

Eligibility and selection of external panelists

The manufacturer and original bureau are both asked to provide, within 10 calendar days of the date of the letter of eligibility, a list of nominees with expertise relevant to the issues being reconsidered.

External panel members must meet conflict of interest (COI) and security clearance requirements. To enable nominees to comply with COI requirements, the manufacturer and original bureau must not contact the nominees or provide them with any material for review.

Learn more about Health Canada's conflict of interest policy for external advisory bodies.

The DG selects panel members after the screening process and within 15 calendar days of receiving the names of the nominees. Selection is based on eligibility (pending security clearance), experience, expertise and analytical skills relevant to the issues being reconsidered.

Questions for the external panel

You and the original bureau will be asked to submit questions for the external panel within 10 calendar days of the date of the letter of eligibility. The questions help the panel focus its deliberations on the specific issues being reconsidered.

The questions should draw upon the expertise of the panelists so that a response to a specific issue can be provided to the DG. They should not:

• lead
  • for example, framed in a way to obtain a desired answer
• be general and unrelated to the scientific or regulatory merits of the submission
  • for example, "should the device be approved?"

The questions will be used to develop the final questions for the panel, which will be shared with all attendees in advance of the reconsideration meeting.

Reconsideration meeting

At a reconsideration meeting, you have an opportunity to share points in the application that support your position with:

• the DG
• designated independent reconsideration advisor within MDD
• internal reconsideration review staff or members of the external panel

At this meeting, there will not be:

• a debate of the issues
• a reconsideration decision made
• any new information shared

If an internal review pathway is selected, a reconsideration meeting (if requested) is held within 35 calendar days from the date that the internal reconsideration review staff are identified. If an external panel review pathway is selected, a reconsideration meeting is held within 70 calendar days from the date the panel is chosen.

In both cases, you will be asked to:

• submit a presentation at least 15 calendar days before the meeting date
• make a formal presentation at the meeting

Following the presentation, questions of clarification for you or the original bureau may be allowed (at the chair's discretion).

Recommendations to the Director General

All relevant material is provided to the internal reconsideration review staff or external panel members for review and consideration. The reconsideration is based on the information available when the original decision was being made, the manufacturer's request for reconsideration and the meeting presentation (if applicable). New information that alters the original application will not be considered.

If an internal review pathway is selected, the results are presented to a designated independent reconsideration advisor within MDD (who was not involved in the original decision) for consideration. The advisor submits their recommendations to the DG within 20 calendar days from the date that the internal reconsideration review staff are identified or from the date of the meeting (if applicable).

If an external panel review pathway is selected, the panel submits a report containing their recommendations for the DG within 15 calendar days from the meeting date. Each recommendation must have the support of at least 2 of the 3 panel members. Consistent with its advisory role, the panel is not asked to make a decision on the application. Rather, advice is solicited through questions provided earlier to the panel.

The reconsideration advisor prepares and presents a summary of the key points in the report along with their own recommendations to the DG within 10 calendar days of receiving the panel’s report.

Possible outcomes of a reconsideration

The DG takes the recommendations from the reconsideration advisor and external panel (if applicable) into consideration before making a decision. The decision is issued within 5 calendar days from when the recommendations were received. The reconsideration decision letter gives the decision and the reasons behind it.

There are 3 possible outcomes of a reconsideration.

1. Decision upheld
   • Application is rejected or refused if the original decision is upheld for the issues under reconsideration.
   • Reconsideration decision letter becomes the final decision.
   • You may refile your application, making the necessary changes to address the issues that led to the negative decision. Learn more about refiling an application.
2. Decision partially amended
   • Application is rejected or refused if the reconsideration results in the original decision being amended for some, but not all of the issues.
   • Reconsideration decision letter becomes the final decision.
   • You may refile your application, making the necessary changes to address the outstanding issues. Learn more about refiling an application.
3. Decision fully amended
   • Application is returned to the application management process for follow-up actions if the reconsideration results in the original decision being amended for all of the issues identified in the original decision letter.
   • The status of the application may trigger 1 of the following actions:
     • the Minister will issue or amend, as appropriate, the MDL for the subject medical device if the device meets the applicable requirements of sections 10 to 20 of the regulations
     • the application will be reinstated and processed in accordance with the application management process, target timelines and performance standards if:
       • a full review of the application, if applicable, was not carried out before the original decision was made (for example, rejected Class III or IV application) or
       • there are outstanding deficiencies that were not part of the basis of the original negative decision