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Eligibility for Abridged Assessment

Eligibility for Abridged Assessment

When considering whether an IVD qualifies for an abridged assessment procedure, WHO takes into account two factors: whether the product has been stringently assessed and, if so, whether the regulatory version of the product submitted for prequalification is the same regulatory version that was stringently assessed. Assessment performed for the following risk classes is considered to be stringent:

Regulatory authority Risk classes undergoing assessment
European Union Annex II, List A
Health Canada Class IV
Therapeutic Goods Administration, Australia Class 4
Ministry of Health, Labour and Welfare, Japan Class III
US Food and Drug Administration Class III

Therefore, an IVD is eligible for abridged assessment if one of the following conditions is met:

  • The regulatory version submitted for WHO prequalification has undergone prior stringent regulatory review by a founding member of the Global Harmonization Task Force (GHTF).
  • The regulatory version submitted for WHO prequalification is different from the version that underwent regulatory review by a GHTF founding member, but there are no substantial differences between the two regulatory versions that will have impact on the safety, quality or performance of the IVD.

An IVD is not eligible for abridged assessment if:

  • The regulatory version submitted for WHO prequalification is different from the version that underwent regulatory review by a GHTF founding member, and there are substantial differences between the two regulatory versions; or
  • No stringently assessed regulatory version of the product exists. This includes products previously assessed by a GHTF founding member (i.e. Australia, Canada, European Union, Japan or the United States) but not according to an appropriate level of stringency (lower risk classification), and products previously assessed by a regulatory authority that was not a GHTF founding member.

An abridged assessment takes into account available evidence that an eligible product meets a number of WHO prequalification requirements as a result of its stringent regulatory approvals. It consists of:

  • performance evaluation including operational characteristics
  • manufacturing site inspection of abridged scope
  • labelling review.

WHO reserves the right to shift from an abridged assessment to a full assessment of a product at any stage in the prequalification assessment process, if the manufacturer fails to submit satisfactory evidence supporting a previous stringent review.