With Legislation In Balance, IRS Gives Temporary Relief From Device Tax Penalty

The Internal Revenue Services will hold off penalizing medical device-makers for late payments of the device tax for the first three quarters of the year, after lobbying from industry and lawmakers.

As lawmakers in Congress work out a continuing resolution that includes a temporary suspension of the 2.3% medical excise tax, federal tax collectors say they will give device-makers a temporary reprieve from having to pay penalties for not paying on time. This would give companies a chance to hold off paying the tax while the issue is being resolved in Congress if that tax is not suspended before Jan. 29, when first payments are due.

The tax on medical devices came into effect as part of the Affordable Care Act. Two years after the tax...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

More from Legal & IP

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

News We’re Watching: New OPEQ Head, Constructive Bio Funding Round, Natera Wins Injunction In Patent Suit

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

More from Policy & Regulation

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Sponsored By

Nancy Tests SPARC-931 Part 7

This is a description