IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.
The 46-page document advises test makers on how to best implement cybersecurity measures under the new regulation, which is set to go into effect in 2022.
The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.
The Eudamed database is an integral part of the new Medical Device and IVD Regulations that go into effect in 2020 and 2022.
If the UK leaves the EU on Oct. 31 without a deal, the Medicines and Healthcare Products Regulatory Agency will start regulating medical devices and IVDs.
The FDA said its new pathway will address diagnostic devices for diseases that are less serious than those associated with its Breakthrough Devices Program.
The revised document addresses a number of issues related to submission of HUD designation requests, which is the first step in seeking marketing approval of such a device.
The agency said its guidance provides transparency about a Humanitarian Device Exemption pathway associated with rare diseases affecting up to 8,000 people.
The lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer.
The new guidance is part of MDR and IVDR, which have increased oversight of diagnostics, many of which were self-certified under previous rules.