Record of Decisions - June 6, 2012, Canada's Medical Device Technology Companies (MEDEC)

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Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program

• Record of Decisions: Canada's Medical Device Technology Companies (MEDEC)
• Location: 1600 Scott Street, Holland Cross, Tower B, 2^nd Floor, Boardroom 2048, Ottawa, Ontario
• Date: Wednesday, June 6, 2012
• Start Time: 1:30 p.m.
• End Time: 4:00 p.m.

MEDEC Participants

Klaus Stitz, MEDEC, Co-Chair

Tonino Antonetti, Roche Diagnostics

Holly Byrd, Siemens

Linda Lindsay, GE Healthcare

Greg Leblanc, Cook Medical

Rochelle Gordon, Sorin

Althea Lawrence, Philips Healthcare

Young Kim, Johnson & Johnson Medical

Sally Prawdzik, LifeScan

Dan Krause, Boston Scientific

Diana Johnson, Alcon

Health Canada Participants

Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Co-Chair

John Patrick Stewart, Acting Senior Executive Director, TPD

Carey Agnew, Medical Devices Bureau (MDB), TPD

Sarah Chandler, MDB, TPD

Gail Gervais, Office of Business Transformation (OBT), TPD

Janet Brunette, OBT, TPD

Christopher Rose, HPFB-Inspectorate

Lisa Lange, Bureau of Policy, Science and International Programs (BPSIP), TPD

John Helmkay, MDB, TPD

Nancy Shadeed, MDB, TPD

Christine Lefebvre, MDB, TPD

Philip Neufeld, MDB, TPD

Bruce Randall, OBT, TPD

Marilena Bassi, OBT, TPD

Mary Raphael, Marketed Health Products Directorate (MHPD)

Dallyn Lynde, MHPD

Randy Duhaime, Policy, Planning and International Affairs Directorate (PPIAD)

Observers

Doug Watson, BPSIP, TPD

Madeleine Marshal, BPSIP, TPD

Heather L. MacDonald, BPSIP, TPD

Nashwa Irfan, MHPD

Patrick Fandja, MHPD

Sebastien Landry, Strategic Policy Branch (SPB)

Lynn Hefferton, OBT, TPD

1. Welcome and Introductions

Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB), welcomed everyone, and a round table of introductions followed.

Klaus Stitz, MEDEC brought apologies from the new Chief Executive Officer (CEO) who wished to attend, but was unable to. He sends his regrets and hopes to attend the next bilateral meeting. Klaus Stitz indicated he was still our main contact with MEDEC.

Organizational Update

Barbara Sabourin provided an organizational update and announced the following changes:

• Barbara Sabourin has now been appointed as Director General for TPD, and John Patrick Stewart, formerly Director of the Office of Clinical Trials, will be the Acting Senior Executive Director for the next few months. Celia Lourenco from the Office of Clinical Trials (OCT) has accepted to act on his behalf. As of April 2, 2012, Marilena Bassi is the new Director for the Office of Business Transformation (OBT). Barbara Rotter, Director of the Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD has retired. Kelly Robinson is now the Acting Director of BMORS.
• Barbara mentioned that TPD came out fairly well with regard to the impact of Budget Implementation 2012. The new cost recovery fee structure put in place last year helped as did the focus on our core business priorities. In total, fifteen positions were affected in TPD, some of which were with Schedule F, Regulatory Amendment Group.
• The Policy functions have changed and will be divided into four areas at the Branch level and the best organizational structure will be determined.

2. Review of Agenda

The agenda was approved.

3. Approval of the Meeting Notes of November 30, 2011

Item 4 - Applications for Combination Products

Action: Linda Lindsay to make contact with MDB as indicated in the previous meeting minutes.

4. Regulatory Modernization

Linda Lindsay, GE Healthcare indicated that further to the Regulatory Modernization panel discussions in 2010-2011, MEDEC would like to have an update on the status of this initiative by the Office of Modernization.

At the autumn 2011 MEDEC conference, Mr. Paul Glover announced that the regulatory renewal would be introduced in waves over a period of several years.

MEDEC is requesting transparency on the priority ranking of modernization issues, including those that were discussed during the panel meeting and any new regulatory issues that have since arisen.

Randy Duhaime, Senior Policy Analyst, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD) advised that there have been no significant changes since autumn 2011. A regulatory roadmap has been prepared which includes details for the coming five years. It is currently being reviewed internally and will be shared externally in the near future.

Regulatory modernization is being rolled out in 3 phases starting with food additives, plain language labelling, and drugs for rare diseases for which policy work is ongoing. A 2 year regulatory plan is to be posted in June. Most modernization of medical devices should happen within the third phase as we look for the most efficiencies and greatest value.

Office of the Auditor General (OAG) issues are not on the pending agenda for phase 1. As well there are no pending changes for the definitions currently in the Food and Drugs Act.

5. Definition of 'Sale'

Klaus Stitz, MEDEC discussed how the definition of 'sale' defines the actions a manufacturer can engage in when a Request for Proposal (RFP) (which is different to a Request for Tender) is issued.

Health Canada has rejected MEDEC's proposal to allow manufacturers to mention unlicensed product if the RFP asks for information on 'future technology' provided that the manufacturer clarifies that:

• The product is not licensed for sale in Canada;
• Date is unknown when licensing by Health Canada will be granted; and
• Orders can only be accepted and executed at a time when licensing is completed.

This process would be in line with the ability of a manufacturer to use information, material and catalogues that contain products that are not licensed in Canada - provided a clear statement to this effect is made. At MEDEC's Regulatory Conference, MDB mentioned that the Bureau has obtained legal advice that could alter the previous practice/decision.

MEDEC would like clarification of application or not, of definition of 'sale' in cases of RFP's where manufacturers are asked to make representation of future technology and acceptance of orders is deferred until Health Canada licence was granted.

Chris Rose, HPFB-Inspectorate, advised that The Medical Devices Program has reviewed the legal opinion and is currently in the process of assessing the impact the proposed change would have on other program areas, such as drugs, Natural Health Products (NHPs) and Biologics.

In regard to 'demos', we may need to review this issue after the RFP situation has been resolved.

6. Definition of 'Surgical Instrument'

Klaus Stitz, MEDEC, reviewed his item which was last discussed at the Bilateral Meeting November 30, 2011.

MEDEC member companies provided a list of products that are Class II devices in Canada and Class I instruments in the United States and the European Union:

• Femoral notch guides;
• Cutting blocks;
• Drill guide assemblies;
• Alignment rods;
• Balancing rods.

Clarification from Health Canada is needed to determine if surgical instruments used for "guiding" or "aligning" fit the definition of surgical instruments.

Nancy Shadeed, MDB advised that in consideration of the definition of "surgical or dental instrument", Medical Devices Bureau has been consistent in its application of this definition and in particular to the intended surgical uses contained within the definition. The intent of this definition is to capture medical devices which have a general purpose or application and which can be used in a variety of surgical proceedings. MDB agrees that the phrase ¨including¨ is more inclusive of words that are included in the definition however the intent would be the same to capture general purpose devices that can be used during surgery. In the case of the devices listed above - they are used for sizing specific implants, or used to insert a specific implant. These devices have no purpose or use in any other surgical procedure other than to assist in the selection of the correct implant, or for the proper placement of a specific implant. The drill guides, cut guides, alignment rods, etc., are all accessories to other medical devices. They do not have a therapeutic function on their own and their function is not comparable to devices that cut, drill, saw, scrape, clamp, etc. It is for this reason that the MDB concludes that the applicable rule for these devices is Rule 1(1).

In comparison to classifications in other jurisdictions, it is important to note that the Food and Drug Administration (FDA) in the United States does not categorize devices using a rule-based system and therefore classification comparisons between the United States and Canada are not appropriate. Although the classification rules are similar with the European Union Directive, the rules in the European Union` use different concepts such as transient use, which is not used in Canadian rules. MDB advised that they are aware of discrepancies in classification rulings which have been provided by Notified Bodies in the European Union, and is not aware of any definitive classification document that has been prepared by any of the Competent Authorities in Europe.

7. Labelling

Rochelle Gordon, Sorin spoke to the e-Labelling notice (November 9, 2010) which has been in process for 18 months. The objective was to roll out the program and review at 1 year and if acceptable, to extend e-labelling to all classes of devices via Compact Disc (CD), Digital Versatile Disk (DVD), or web based.

The FDA currently accepts web-based labelling for prescription devices. The European Union will also implement a similar program this March 2013. Health Canada was to consult with end-users regarding current e-labelling practice to review any issues or concerns.

MEDEC would like to see e-labelling extended to all classes of device to be in line with all major Authorities and Geographies.

Nancy Shadeed, MDB, TPD advised that the 2010 notice on e-labelling included contact information to which the concerns of stakeholders or users could be directed. No comments have been received in the time that this notice has been posted, and Health Canada considers the review to be complete.

With regard to extending e-labelling to all classes of devices, it was clarified that device manufacturers are currently authorized to provide all labelling information (as outlined in section 21(1) of the Medical Devices Regulations) on either Compact Disk - Read Only Memory (CD-ROM) or Digital Versatile Disk - Read Only Memory (DVD-ROM) for all classes of devices that are not intended to be sold to the general public. The web-based publication of a device's Directions for Use is limited to Class IV devices and in vitro diagnostic devices (IVDDs) that do not fall within the definition of near patient IVDD. Since all users of these types of devices are considered to receive technical training in the operation of these devices, the requirements of section 21(2) do not apply and this information may be provided solely as downloadable data. However, an amendment to the Medical Devices Regulations would be required to allow the directions for use of a Class I, II or III device to be web published. In addition, all regulatory amendments must be considered in the context of current Branch regulatory priorities.

Because of differing frameworks and regulatory language, the Canadian position on web-based labelling cannot be fully aligned with the positions of either the United States FDA or the European Commission. It is observed that the web-based labelling of some devices is permitted in the European Union and the United States, but not Canada. However, there are also some Class IV devices for which web-based labelling is allowed in Canada but not in the European Union.

Barbara Sabourin asked that MEDEC forward to TPD information on licensing/post-licensing applications for further investigation. We hope to flag this to the Office of Legislative and Regulatory Modernization (OLRM) in regard to plain language labelling.

Action: MEDEC to provide information as requested for further review and consultation with OLRM.

8. Transparency of Delays in Application Screening & Review

Klaus Stitz, MEDEC indicated that member companies are still very concerned about licence application review times and about the lack of transparency that hinders the Regulatory Affairs Department to provide proper planning information to management.

Philip Neufeld, MDB provided the following information in response to MEDEC's concerns:

1. Requests for information already provided
   Screening deficiency letters (SDL) are sent when an entire section of information is missing, or the information provided is incomplete. Sometimes, the information requested in an SDL was provided in the submission but our reviewer missed it because the information was not in the expected place, or parts of the information were included in separate places. If we cannot find the information, we often ask the applicant to tell us where it can be found in the submission, rather than resubmitting it.
2. Frequency of SDLs
   Health Canada appreciates direct feedback from applicants who have experienced this issue often, so that we can identify the causes and make improvements.
3. Requests for information beyond what was customary
   There might be several reasons for this observation. In certain Sections of the Division, screening is assigned to evaluators who have specialty expertise in the subject device technology and are likely to be assigned the file for review. As a result, they may include some detailed, technical questions in the SDL which they consider as key elements for review. Section Heads may also include more technical questions in SDLs when preclinical or clinical study reports are found to be so deficient as to compromise their validity in supporting device safety and effectiveness. The purpose of asking for technical level data at screening is to have a complete review package for evaluation. Accepting a deficient submission at screening and waiting until the review stage to address the deficiencies would not be fair to applicants who waited until they have all the required data before submitting their application.

   SDLs will not eliminate the possibility of having additional information (AI) questions during scientific review. Improved organization of the submission package certainly helps the review process and reduces the number of AI questions in the end.

4. 15-day deadline for response to Screening Deficiency Letters
   As MEDEC has stated, extensions to the 15-day limit are granted when required. There have been some cases in which the companies have not fully completed the required studies when the applications are filed. Manufacturers may think that 15 days is not sufficient time to generate the missing data. They should remember that they are not expected to conduct additional studies during this 15-day period, since all data should be available and all necessary testing should be completed at the time the application is submitted.

   Requests for information beyond that required by regulations
   Examples like the ones given here are not acceptable deficiency questions. We believe the situations listed here do not happen frequently. We will share these concerns with Device Evaluation Divisions (DED) Section Heads to improve our procedures.

5. Requests for information not required in recent previous applications
   We have made efforts to improve the consistency of SDL questions. We coach the evaluators who screen files for Section Heads, and discuss screening issues at Section meetings. However, it is idealistic to expect to eliminate all inconsistency issues in this area due to the variances of evaluators' expertise and experience, and the wide variety of technologies covered by each of the review Sections.
6. AI requests sent very close to target date for review
   Target performance times (75 days for Class III and 90 days for Class IV) apply to the first review decision, which may be a licence recommendation or a request for AI. We try to include all AI questions in the first request, so we have to review the entire file. Sometimes this takes almost all of the target time.
7. Screening process does not appear to speed up review or reduce volume of AI requests
   We do not think that the current screening practice causes longer approval times. Based on our observations, since last year, the average size of submissions is becoming bigger and often a single application includes multiple components and multiple changes. With this type of submission, there is a higher probability of issuing AI questions because of the multiplication of review subjects.

   Barbara Sabourin, TPD, stated that we do not delay screening as a principle, and that we are looking at ways to minimize penalties, but we do measure many things.

   Klaus Stitz, MEDEC looks forward to the opportunity to work with John Helmkay, MDB in regard to different reporting requirements and options.

   Action: MEDEC to contact John Helmkay, MDB for further discussions.

9. Special Access Applications (SAP)

Greg Leblanc, Cook Medical stated that with the introduction of new forms for SAPs, there appear to have been changes in process. These changes seem to impact new and existing applicants, and both first-time devices, or devices that have been processed and reviewed previously.

Although MEDEC understands the intent of the SAP and direction it is taking, it appears that this new process is creating additional work for all parties involved. MEDEC would like clarification of the new process and philosophy, and a collaborative approach to meet the goals of the program while reducing unnecessary burdens all around.

Christine Lefebvre, MDB indicated that in December 2011, the Medical Devices Special Access Programme released a new application form for custom-made devices and medical devices for special access. While the form incorporated minor formatting issues in an attempt to reduce confusion for the application process, the form also addressed key areas of the regulations supporting SAP which were not addressed in previous application iterations, namely item 71(2)(h) of Part 2 of the Medical Devices Regulations. This item specifies that an application for special access submitted by a health care professional must include the known safety and effectiveness information in respect of the device.

Health Canada is currently working on providing information/training to industry as was done for professionals.

Philip Neufeld, MDB re-iterated the fact that the manufacturer is not the co-applicant of the request.

10. Pipeline Forecasting

Klaus Stitz, MEDEC stated that further to OBT, TPD addressed this issue at a previous Bilateral Meeting, and was seeking collaboration with MEDEC to streamline mechanisms to capture product pipeline information in a useful way for the anticipation of future workload of the Medical Devices Bureau. MEDEC was interested in a status update and hearing about the benefits of this to Health Canada.

MEDEC's Regulatory Affairs Steering Committee (RASC) discussed the Pipeline Forecasting Project of TPD at its Meetings on December 7, 2011 and February 8, 2012 and is concerned about the usefulness of the data to be collected and the effort spent.

Bruce Randall, OBT, TPD indicated that the response rate has been poor. Health Canada continues to heavily scrutinize the information as we need to continue with our forecasting. This information is very important for our budget/workload estimates and Health Canada is willing to discuss options with MEDEC.

Barbara Sabourin TPD stated that we do have a certain level of discomfort in using past information for future projections. While some may feel it is not worthwhile, we need to continue this for our budget projections. We continue to seek MEDEC's help as we go through this exercise to better understand our monetary and resource requirements. Any validation of our forecasting is helpful to us.

Action: MEDEC to provide feedback as to how Health Canada can best capture medical devices pipeline information.

11. Restructuring of Systems Licenses

Klaus Stitz, MEDEC discussed the fact that MEDEC member companies - and most likely also the industry in general - are concerned by recent activities of the Medical Devices Bureau which they feel are going beyond the definitions provided by the regulations or guidance.

Medical Device Regulations
"System" means a medical device comprising a number of components or parts intended to be used together to fulfill some or all of the device's intended functions, and that is sold under a single name.

Guidance Document: How to complete the Application for a New Medical Device Licence
"System" means a medical device comprising a number of components or parts intended to be used together to fulfill some or all of the device's intended functions, and that is sold under a single name and are manufactured by the same manufacturer. Examples might include hip prostheses, knee prostheses or an ultrasonic imaging system.

Examples given referred to

• Magnetic Resonance Imaging (MRI) systems that come with different coils and are said to require separate licences although the coils are component parts that can only be used with the magnet;
• In Vitro Diagnostic Devices (IVDD) systems with components - same issue; and
• Instrument systems with components - same issue.

As a consequence for example, (e.g.) a Class III system license was re-organized into one Class III license with a number of Class IIs or a multitude of separate Class II / Class III licences. This approach does increase the number of licences and also increases significantly the cost/fees.

MEDEC asks for a review of the process and better understanding of how a proper systems approach can be managed.

Sarah Chandler, MDB provided the following definition of a system from the Medical Devices Regulations is as follows:

"System" means a medical device comprising a number of components or parts intended to be used together to fulfill some or all of the device's intended functions, and that is sold under a single name.

The "Guidance Document for the Interpretation of Sections 28 to 31: Licence Application Type" that has been in place since 1999 states the following:

A SYSTEM refers to a MEDICAL DEVICE, including an in vitro diagnostic device, that is sold under a single name and contains a number of COMPONENTS intended to be used together to fulfill some or all of the device's intended functions. COMPONENTS not sold under the SYSTEM name cannot be licensed with the SYSTEM, even when they are intended to be used together.

MDB indicated that they have endeavored to consistently interpret the system definition based on the above definition and guidance. If components are sold without the system name, they cannot be licensed on a system type licence and require separate licences. The examples listed above do not contain enough detail to determine whether MDB is not being consistent. MDB asks that MEDEC provide detailed examples of licence applications, where MDB did not consistently apply the use of the definition and guidance document.

Barbara Sabourin suggested that at the next bilateral meeting MDB provide a presentation on how our licenses are structured.

Action: MEDEC to provide MDB with examples of license applications applied inconsistently.

Action: MDB to provide a presentation on license structuring at the next bilateral meeting with MEDEC.

12. MDB Performance Reporting

John Helmkay, MDB provided a presentation on performance reporting with specific information on volumes for different device classes.

Barbara Sabourin suggested that if desired MEDEC provide us with a list of information and/or statistics they would like to see so that we could provide this on a regular basis.

Action: Klaus Stitz, MEDEC to put a list together and forward this to MDB for their consideration and action.

13. Mandatory Reports

Dallyn Lynde, MHPD provided information on mandatory reports indicating that volumes were similar to last year. MHPD is currently in the process of conducting a six month follow-up to see how we are doing and obtaining feedback on how to improve.

14. Roundtable

1. Therapeutic Products Directorate Forward Planning Initiatives
   Lisa Lange, BPSIP outlined the initiatives that are currently active and which may require industry input in the near future. Where possible, the anticipated timing of the projects was provided to facilitate the coordination of member input by MEDEC. A handout was circulated.

15. Adjournment

Meeting adjourned at 4:10 p.m.

16. Next Meeting

Wednesday, November 14, 2012 at 1:30 p.m.

Original signed by

Barbara J. Sabourin
Director General
Therapeutic Products Directorate