Further clarification on fluorescein strips

After months of doubt over the classification of fluorescein strips following Bausch+ Lomb’s discontinuation of Fluorets, the Medicines and Healthcare Products Regulatory Agency (MHRA) has issued further clarification on their use.

The view of the agency, reassuring practitioners they can use CE-marked fluorescein strips, had been sought by the General Optical Council since its own guidance in September last year (News 27.09.13).

A statement said: ‘The MHRA’s position is that fluorescein strips intended for diagnostic purposes are regarded as medicinal products because they are in vivo diagnostic agents. Therefore they need a marketing authorisation under the requirements of the medicines legislation if they are intended for diagnostic purposes.