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.
The American Academy of Family Physicians said that the changes being considered by CMS would increase the financial burden on laboratories.
The guidance is the first of several that will cover the new medical device and in vitro diagnostic regulations, which are set to come into force by 2020 and 2022, respectively.
The guidance advises sponsors to work with the agency to create a development plan for the drug and test early on so they are reviewed and launched around the same time.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
While companies are expected to have their IVDs certified under the new regulation by 2022, manufacturers are frustrated by the slow pace of the certification process.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.