Regulatory Oversight of Genetic Testing in Canada Health Canada Perspective

Patrice Sarrazin, PhDSenior Scientific EvaluatorIn Vitro Diagnostic DevicesMedical Devices BureauTherapeutic Product DirectorateHealth Canada

patrice.sarrazin@hc-sc.gc.ca

Outline

1. Definition2. Food and Drugs Act and Medical Devices Regulations3. Classificiation of Medical Devices4. Investigational Testing5. Application for a Medical Device Licence6. LDTs and DTC Genetic Testing: Where do they fit?

Definitions

“device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

(b) restoring, correcting or modifying a body function or the body structure of human beings or animals,

(c) the diagnosis of pregnancy in human beings or animals, or

(d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

Devices (Food and Drugs Act)

Definitions

“genetic testing” means the analysis of DNA, RNA or chromosomes for purposessuch as the prediction of disease or vertical transmission risks, or monitoring,diagnosis or prognosis.

Genetic Testing (Medical Devices Regulations)

“in vitro diagnostic device” or “IVDD” means a medical device that is intended to be used in vitro for the examination of specimens taken from the body.

In Vitro Diagnostic Device (Medical Devices Regulations)

Definitions

“manufacturer” means a person who sells a medical device under their ownname, or under a trade-mark, design, trade name or other name or mark ownedor controlled by the person, and who is responsible for designing, manufacturing,assembling, processing, labelling, packaging, refurbishing or modifying thedevice, or for assigning to it a purpose, whether those tasks are performed bythat person or on their behalf.

Manufacturer (Medical Devices Regulations)

Food and Drugs Act & Medical Devices Regulations

Health Canada regulates the manufacture and sale of medical devices in Canada.

The Food and Drugs Act and Medical Devices Regulations are the tools used toensure that safe and effective devices are available.

Manufacturers of devices apply to Health Canada to receive either:

1. Medical Device Licence2. Investigational Testing Authorization3. Special Access Program Request

Food and Drug Act = http://laws.justice.gc.ca/eng/C.R.C.-c.870/index.html

Medical Devices Regulations = http://laws.justice.gc.ca/PDF/Regulation/S/SOR-98-282.pdf

As per rule 4 of the Risk Based Classification System, IVDDs intended to be used for genetic

testing are classified as Class III

Risk Based Classification System for Medical Devices

Class I (Thermometer)

Minimal risk.

Class II (Culture media)

Low public health risk or moderate individual risk.

Class III (MRSA detection)

Moderate public health risk or high individual risk.

Class IV (HIV Donor Screening)

Present a high public health risk.

Schedule 1Classification Rules for Medical Devices

Part 1Medical Devices other than IVDD

Part 2In Vitro Diagnostic Devices

Based on public health and individual riskand IVDD use outcome

Ris

k le

vel

for I

VDD

Regulatory Pathways

Investigational Testing Authorization

Medical Device Licence

Special Access Program

Investigational Testing Requirements

A manufacturer or importer of a Class II, III or IV medical device may sell the device toa qualified investigator for the purpose of conducting investigational testing if themanufacturer or importer holds an authorization issued under the Medical DevicesRegulations and possesses records that contain all the information and documentsrequired by the regulations.

a) Manufacturer informationb) Device name & identifierc) Device description & materialsd) Intended Usee) Marketing historyf) Risk Assessmentg) Investigators Informationh) Institutions (written approval)i) Study protocolj) Labellingk) Investigator’s Agreement

Pharmacogenomics Trials

Application for Investigational

Testing Autorization

Drugs / BiologicsOffice of Clinical Trial, TPD or BGTD

Companion DiagnosticsMedical Devices Bureau

Application for Clinical Trial Autorization

PGx Trials

Investigational Testing Autorisation

Letter

No Objection Letter (NOL)

30 day default period30 days

At the clinical trial stage, PGx testing used for diagnostic purposes or patient managementcan be achieved in two ways:

(i) Use of a PGx test that is licenced for sale in Canada;

(ii) Use of a PGx test that is authorized for investigational testing

Test licenced in Canada

Guidance Document: Submission of Pharmacogenomic Information

Application for a New Medical Device Licence

Identification information

• Background Information

• Summary of S & E Studies! List of Standards

! Method of Sterilization

! Summary of Studies

! Bibliography

• Labelling

• Near Patient IVDD

ISO 13485 Quality System

Certificate from CMDCAS

“recognized” auditing

organization

Requirements for Class 3 Device Licences

Supporting the Safety and Effectiveness

Basic parameters to be controlled for when validating a commercially available kit

• Analytical Specificity• Limit of detection (LOD)• Linearity range• Lower Limit of Quantification (LLOQ)• Upper Limit of Quantification (ULOQ)• Precision (intra-run, inter-run, inter-lab, inter-lot)• Accuracy• Recovery• Matrix interference• Open and On-board Stability• Shelf Life Stability (-20°C, -80°C)• Freeze/Thaw Stability• Working Standard Solutions Stability• Reference ranges

This list is not comprehensive and may vary.

LDTs & DTC Genetic Testing

Laboratory-developed tests and Direct-to-Customer genetictesting fall outside the scope of the Food and Drug Act and theMedical Devices Regulations.

Laboratory-Developed Tests = Test not manufactured for sale

DTC Genetic Testing = Testing services fall outside the scope of the regs

Baby Gender Test Kit•Pregnancy test kit•Alcohol pad•Blood collection device (lancet)•Collection card•Return envelop

Reception of the sample collection kit Specimen collection

ShippingLaboratory testing

Online Order

Direct-to-Customer Genetic Testing

Results providedto the customer

Regulatory oversight of DTC Genetic Testing

Testing services are not regulated under the Food and Drug Act

What about the sample collection kit?

• Pregnancy test kit = Class II Medical Devices

• Desinfectant pad

• Blood collection device (lancet) = Class II Medical Devices

• Collection card

• Return envelop

Consult the Medical Device Active Licence Listing (MDALL)www.mdall.ca

It’s Your Health Articles

•Buying drugs over the internet

•Medical Devices Test Kits for Home-Use

Joint publication produced by Health Canada and the Public Health Agency of Canadathat provides information you can trust on a wide range of health and safety issues.

www.hc-sc.gc.ca

Public Notices

Regulatory Oversight of In-House Genetic Tests

Genetic Tests developed in-house !"#$%"&'()*+%',"-."/'+*%0"1+2+,+

Clinical Laboratories under provincial jurisdiction(oversight varies from province to province)

Accreditation Programs based on ISO 15189: Medical Laboratories Particular requirements for quality and competence

Provisions for in-house procedures:5.5.1 … If in-house procedures are used, they shall be appropriately validated fortheir intended use and fully documented.

5.5.2 The laboratory shall use only validated procedures for confirming that theexamination procedures are suitable for the intended use.

!

!

Health Portfolio working group on personalized medicine – mandated to conductcomprehensive policy analysis on personalized medicine.

Need to ensure that there is a coordinated approach that protects and promotes the healthof Canadians, while maximizing the advantages offered by personalised medicine.

Activities that Health Canada has been involved in so far include: PharmacogenomicsGuidance document, participation in ICH E-15 and E-16 initiatives, and regulatorymodernization.

Personalized Medicine Working Group

Question ?

Therapeutic Products DirectorateMedical Devices BureauLicensing Services DivisionRoom 1605, Statistics Canada Main Building,150 Tunney’s Pasture DrivewayOttawa, Ontario K1A 0K9Address Locator: 0301H1Phone: 613-957-7285Fax: 613-941-4726E-mail: mgr-lsd_mdbtpd@hc-sc.gc.ca