Notice to Industry - Risk Classification of Diagnostic Ultrasound Systems and Transducers

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Therapeutic Products Directorate / Direction des produits thérapeutiques
Holland Cross, Tower "B" /Holland Cross, tour "B"
6th Floor, 1600 Scott Street / 6e étage, 1600, rue Scott
Address locator: 3106B / Indice de l'adresse : 3106B
Ottawa, Ontario
K1A 1B6

May 17, 2002

To: Device Licence Holders of Diagnostic Ultrasound Systems and Transducers

RISK CLASSIFICATION OF DIAGNOSTIC ULTRASOUND SYSTEMS AND TRANSDUCERS

This notice is to communicate the Medical Device Bureau's final decision on the appropriate risk classification for Diagnostic Ultrasound Systems and Transducers.

Since July 1, 1998, when the Medical Device Regulations came into force, the Medical Devices Bureau issued many Class II device licences for these devices. Following further consideration by the Bureau, the more appropriate classification rule to be applied to these devices is Rule 10(2). Therefore, in general, these devices are Class III medical devices. Rule 10(2) of the Medical Device Regulations reads:

A device described in subrule (1) that is intended to be used to monitor, assess or diagnosis a disease, a disorder, an abnormal physical state or a pregnancy, if erroneous readings could result in immediate danger is classified as Class III.

Diagnostic Ultrasound Systems and Transducers are devices used to monitor, assess or diagnosis a disease, a disorder, an abnormal physical state or pregnancy. In the context of diagnostic ultrasound systems and transducers, the Medical Devices Bureau applied the following interpretations to this classification rule: An "erroneous reading" may be attributable to the quality of the imaging, the interpretation of the image or a combination of these two factors. "Immediate" denotes a temporal relationship in the context of the use of these devices in urgent or emergent clinical situations and "danger" may result from inappropriate intervention or a decision not to intervene, based on the erroneous reading.

Therefore, ultrasound diagnostic systems and transducers will be classified as Class III devices. However, there are exceptions such as devices (transducers) intended to be used in direct contact with the central nervous system or the central cardiovascular system. Applying classification Rule 1(2):

a surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero", these devices will be classified as Class IV devices.

In May of 2001 and then again in October 2001, consultation was sought from affected device manufacturers on the proposed reclassification of Diagnostic Ultrasound Systems and Transducers.

While manufacturers did express concern about the need to re-classify these devices whose history of safe and effective use has been well documented, manufacturers did not express any foreseen difficulties in complying with the safety and effectiveness requirements of Class III or IV products.

The safety and effectiveness requirements prescribed for Class III and Class IV for ultrasound systems and transducers in Canada is consistent with those in other regulatory jurisdictions.

After considering manufacturers comments, it is the decision of the Medical Devices Bureau to apply the appropriate Rule and to regulate Diagnostic Ultrasound Systems and Transducers as Class III or Class IV medical devices. The MDB recognizes that these devices have demonstrated a long history of safe and effective use as a Class II medical device and that manufacturers may require time to gather the required supporting data for submission and review. Our process to replace existing Class II licences for these devices will include adequate time to collect and submit information on safety and effectiveness that was not required prior to this decision/ruling.

The process for new applications and issuing Class III and Class IV licences to replace existing Class II licences for these devices is as follows:

1. Manufacturers,whose devices were "previously notified" and obtained Class II licences in accordance with the "Transitional Provisions"
   (Part 5) of the 1998 Regulations will be issued new Class III or Class IV licences, as appropriate, on or before August 1, 2002.
   
   
2. Manufacturers, who have applied for and received new Class II licences since July 1, 1998, will be issued Class III or IV licences with conditions on or before August 1, 2002. Manufacturers will be required to submit supplemental information in accordance with Section 32(3) or Section 32(4) of the Regulations within 60 days of the receipt of the Class III or Class IV licence. Manufacturers may continue to sell these devices while the information is being reviewed and no fees for the review of this information will be charged. If the supplemental information is found to be satisfactory, the licence will be re-issued to remove the conditions.
   
   
3. Information not submitted within the 60 day time frame and information that is deemed not to support the safety and effectiveness of the device will result in licence suspension in accordance with Section 40 of the Regulations.
   
   
4. All applications received for Diagnostic Ultrasound Systems and Transducers after the effective date of this notice will only be accepted if:
   1. The device is identified as a Class III or Class IV device, as appropriate
   2. The application is accompanied by information in support of safety and effectiveness as set out in section 32(3) or section 32(4) as appropriate.
   3. The appropriate fees are paid.

The effective date of the device classification decision will be July 1, 2002

Should you have any questions or require further clarification relating to this notice, please contact the Licensing Services Division of the Medical Devices Bureau at (613) 957-7285.

Original Signed By:

Robert G. Peterson, M.D. PhD. MPH
Director General
Therapeutic Products Directorate