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CMS Could Streamline Coverage For Breakthrough Medtech Under House Proposal

 
• By Sue Darcey

Newly introduced bill would seek to smooth the Medicare coverage and reimbursement pathway for breakthrough devices.

Newly proposed legislation in the US House could help innovative medtech products get market pick-up more quickly by permitting three years of transitional coverage by Medicare for products designated by FDA as “breakthrough devices."

The “Ensuring Patient Access To Critical Breakthrough Products Act,” H.R. 5997, introduced June 5 by Reps. Suzan Delbene, D-Washington, and Jackie Walorski, R-Indiana, and co-sponsored by Reps

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FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.