Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Other items for an interim order submission

On this page

• Items to include in the submission
• Conditions of IO authorization
• Post-market requirements

Items to include in the submission

For an IO submission, Health Canada requires a report on the results of the performance testing requirements that apply to the product class. Any deviations should be identified and explained.

Along with the performance testing results, the IO submission should include:

• a description of the device
• engineering drawings
• material specifications
• intended use
• shelf life
• labelling

Device description

The device description should include:

1. engineering drawings
2. material specifications (a detailed chemical and physical identification of all materials used in the final components of the respirator)
3. a description of the intended use for the device

Engineering drawings

Engineering drawings are to be completed and submitted for each product. They must include critical and major dimensions of the product (for example, as defined within the design specifications and/or acceptability criteria outlined in Appendix 1). All product components must be labelled and the same labels are to be used for the material specifications. Engineering drawings are to display all views of the product, including any cut-outs that are considered necessary.

Submit any changes to the engineering drawings to Health Canada before implementing the changes.

Material specifications

The material specifications are a list of components used to assemble the product. Identify the components as critical or non-critical. Component that will influence the fit, form or function of the product are considered “critical.”

The components must be identified using labels in the engineering drawings. Specifications for all critical components as well as associated tolerances are to be identified. Tolerances must be within reason to ensure that the fit, form or function of the product is not altered if the limits of the tolerances are reached. For example, identify:

• filtration media by material type, basis weight with associated tolerances, filtration efficiency and associated tolerances, breathing resistance and associated tolerances
• headstrap material by material type, basis weight with associated tolerances, elasticity and associated tolerances

Submit any changes to the material specifications to Health Canada before implementing the changes.

Intended use

The intended use describes the conditions and situations under which the manufacturer intends the device to be used (for example, clinical use). Key performance characteristics that have been tested and verified are also linked to the types of uses. Performance characteristics may also include limitations due to temperature, storage, reuse/cleaning and disinfection, and so on.

Shelf life

Indicate the device’s useful shelf life, the filter components and the storage conditions (for example, temperature, humidity) in the product labelling. Shelf life is to be validated through one or more of the following:

• information sources, such as material supplier data
• testing, such as real-time or accelerated aging tests
• other appropriate methods

Include a report on validation testing and/or other data supporting the shelf-life claim in the IO submission. For example, ASTM F1980 can be used to guide accelerated aging studies, which should be followed by performance studies. This information should outline suitable storage conditions (such as storage temperature and humidity) to ensure the shelf life can be met. The product must also have an expiration date.

Health Canada understands that a manufacturer may not have completed results. We do, however, expect the manufacturer to demonstrate a plan for this testing, evidence that accelerated testing has begun and an estimated date for when the results will be provided.

Following IO authorization and any newly completed test results, the manufacturer is required to submit an amendment to their IO for Health Canada to review. If there’s a difference in the estimated shelf life and storage conditions on the label, this should be clarified with customers at a later date and with updated labelling.

Labelling

Labelling requirements are outlined in the following sections.

Standardized markings for Canadian respirators

Table 3 lists the markings that should be indicated on all FFRs manufactured in Canada. Table 4 details the labelling notations that are required.

Table 3. Canadian manufactured respirator protection level and associated identification

Identification	Performance	Test method
95PFE	Greater than or equal to 95% particulate filter efficiency	NIOSH determination of particulate efficiency level for N95 filters
99PFE	Greater than or equal to 99% particulate filter efficiency
100PFE	Greater than or equal to 99.97% particulate filter efficiency
95PFE-L#	Greater than or equal to 95% particulate filter efficiency Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1, 2 or 3, whichever is the highest level obtained by product	NIOSH determination of particulate efficiency level for N95 filters ASTM F1862 standard test method for resistance of medical face masks to penetration by synthetic blood U.S. flammability standard (CPSC CS-191-53 flammability test method (16 CFR Part 1610)
99PFE-L#	Greater than or equal to 99% particulate filter efficiency Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1 , 2 or 3, whichever is the highest level obtained by product
100PFE-L#	Greater than or equal to 99.97% particulate filter efficiency Fluid resistance to specified ASTM level 1, 2 or 3.  # will represent 1 , 2 or 3, whichever is the highest level obtained by product

Table 4. Labelling notation expected on the respirator

Labelling instructions	FFR	Elastomeric respirator	Filters for elastomeric respirator
Name and model number of device	Yes	Yes	Yes
Name of manufacturer	Yes	Yes	Yes
Product level of protection (see Table 3)	Yes	No*	Yes*
Health Canada IO authorization number	Yes	Yes	Yes

For a single-use FFR, you should provide the:

• name and model number of the device
• name of manufacturer
• level of protection (see Table 3) and
• Health Canada IO authorization (also the IO application number).

For an elastomeric respirator, you should provide the:

• name and model number of the device
• name of manufacturer and
• Health Canada IO authorization (also the application number)

Filter protection level is provided on the filter.

Packaging labelling

Labelling is to be provided in both official languages. The packaging must include:

• name and device identifier (for example, model number) of device
• product level of protection (see Table 3)
• specific level of protection provided by the respirator (95%, 99%, 99.97%):
  • for non-surgical respirators: “95PFE: Greater than or equal to 95% particulate filter efficiency effective against particulate aerosols free of oil; time use restrictions may apply”
  • for filters with a surgical respirator designation:“99PFE-L3: Greater than or equal to 99% particulate filter efficiency; flammability; and level 3 fluid resistance to ASTM F2100-19 effective against particulate aerosols free of oil; time use restrictions may apply”
• name of manufacturer
• IO authorization number
• lot number
• shelf life (for example, storage duration/expiration date and conditions)
• cleaning and/or reprocessing instructions (up to the maximum number of cycles) if the product can be reused; if not, state “for single use only”
  • donning and doffing instructions
• a guide to the acceptable types and capabilities if more than one type of filter can be used with a facepiece

Also include the following cautions and limitations:

• Do not use in atmospheres containing less than 19.5% oxygen.
• Do not use in atmospheres immediately dangerous to life or health.
• Do not exceed maximum use concentrations established by regulatory standards.
• Failure to properly use and maintain this product could result in injury or death.
• All approved respirators shall be selected, fitted, used and maintained in accordance with OSHA, CSA and other applicable regulations.
• Never substitute, modify, add or omit parts. Use only exact replacement parts in the configuration as specified by the manufacturer.
• Indicate if the device contains materials made of latex.
• State that the respirator helps protect against certain particulate contaminates but does not eliminate exposure to or the risk of contracting any disease or infection.

Quality management

In accordance with the IO, manufacturers must either:

• demonstrate conformity with appropriate quality management systems standards (for example, ISO 13485 certificate) or
• provide a clear description of how quality will be managed in accordance with ISO 13485 and/or other appropriate standards

Quality management will be assessed both before and after IO authorization as follows:

• pre-assessment of the quality plan, records, sampling plan and acceptance criteria before IO authorization
• post-IO assessment to confirm quality systems are being reported and functioning as planned
• post-IO participation in proficiency testing and/or user group assessments to confirm ongoing quality control of key performance criteria

Both steps in the post-authorization review are conditions of IO authorization for Canadian manufacturers of FFRs.

Manufacturing process

Describe the manufacturing process in detail using a flow chart or in text form. Include details of the entire process, from when raw materials are received to when the product is manufactured. Be sure to specify the process used to perform operations, such as welding headstraps.

Note: Changes to key suppliers, materials, fit, form or function of the FFR or the manufacturing process during the IO process must be submitted to Health Canada before they are implemented. After authorization, any changes must be submitted in the form of an IO amendment to Health Canada. Health Canada will review the effects of such changes. Authorization will be required before post-authorization changes are implemented.

Quality control plan

Include a quality control plan that identifies which steps in the manufacturing process require process validation (see Appendix 1). This validation process should be addressed as part of the sampling plan and acceptance criteria. 

Sampling plan and acceptance criteria

A detailed sampling plan, along with the acceptance criteria, forms part of the IO submission. It should follow the outline provide in Appendix 1.

The plan must demonstrate that systems are set in place to ensure the quality of the respiratory protection provided by the respirator. For reference, please see the plan used in NIOSH-certified respirators.

The sampling plan should follow international standards for sampling by:

• variables (for example, ASTM E2762) or
• attributes (for example, ASTM E2234, ISO 2859-1, or ANSI/ASQC Z1.4) 

The sampling procedure must also include a list of the characteristics to be tested by the manufacturer. The characteristics listed need to be classified according to their potential effect. The sampling plan and acceptance criteria should be provided for review and approval by Health Canada in the IO submission and must include the contents outlined in Appendix 1.

Quality control records

A quality control records plan should demonstrate how quality control records are to be kept. The manufacturer must also attest to the plan in writing and should provide a summary of the plan that outlines the methods and measures to be followed. The quality inspection control records must be sufficient to carry out the procedures for sampling by variables or by attributes.

Records should be retained for 2 years past the stated shelf life of the FFR.  

Note: Any changes to any part of the submission during the IO process must be submitted to Health Canada before changes are implemented. These changes include indications for use, engineering drawings, materials specifications, manufacturing process or plan, and materials or product design. If changes are made following an IO authorization, the manufacturer must submit those in the form of an IO amendment to Health Canada, as these may trigger changes in performance and/or acceptability criteria.

See Appendix B for an IO submission checklist.

Conditions of IO authorization

All authorized IOs are subject to conditions of continued quality as determined by Health Canada at the time of IO authorization, if granted. These may include ongoing evidence of safety, effectiveness (for example, performance criteria) and quality, which are determined through:

• post-IO assessment to confirm quality systems are being reported and functioning as planned
• post-IO participation in proficiency testing and/or user group assessments to confirm ongoing quality systems of key performance criteria

Post-IO conditions may be satisfied by undergoing a certification process, such as the ones offered by CSA or NIOSH. The manufacturer is responsible for obtaining certification.

Information on the well-established NIOSH certification process can be found on the NIOSH website. Information on the newly established CSA certification program can be obtained by contacting the CSA Group.  

Post-market requirements

Manufacturers must comply with the post-market requirements of the Medical Devices Regulations. These include provisions related to recall procedures, mandatory problem reporting, and complaint handling. Health Canada has published a notice informing manufacturers of their post-market obligations related to mandatory problem reporting.

Within 10 days of becoming aware of an incident in Canada, all IO authorization holders must:

• report the incident
• specify the nature of the incident
• specify the circumstances surrounding the incident

While the IO does not have unique requirements related to recalls, any device authorized under the IO is subject to the mandatory recall provisions under the Food and Drugs Act. Also, while the Minister has the ability to order a mandatory recall, manufacturers should proactively notify Health Canada if they become aware of the need to recall their COVID-19 medical device in Canada. The guide to the recall of medical devices provides guidance on how to conduct a recall in Canada.

Health Canada may engage in activities to assess compliance with the IO authorization and take immediate action when non-compliance is confirmed. This includes stopping the importation and sale of any products that are found to pose a risk to the health of Canadians.