Commercial Operations

Congress Passes Two-Year Suspension on Medical Device Excise Tax, Again

The Affordable Care Act’s widely unpopular medical device excise tax is off, again, for now. Read More

Flu Season Impacts IV Product Shortage

The “worse-than-typical flu season” is affecting the ongoing shortage of IV saline products, which was exacerbated by the destruction in Puerto Rico by Hurricane Maria, according to FDA Commissioner Scott Gottlieb. Read More

IRS Decides Not to Impose Penalties on Medical Device Excise Tax through Q4 2018

The U.S. Internal Revenue Service and the Department of Treasury will not impose penalties on devicemakers liable for the ACA’s medical device excise tax until Q4 2018. Read More

Electric Power at All Baxter Facilities in Puerto Rico Finally Returns

Following several months of efforts in Puerto Rico to recover from the widespread destruction from recent hurricanes, all three of Baxter’s IV saline and amino acids manufacturing facilities on the island are back on the power grid. Read More

PTAB Sides with Minerva Surgical, Nixes Hologic Patent

The PTO’s Patent Trial and Appeal Board invalidated a Hologic patent on the use of its NovaSure endometrial ablation system in an inter partes review requested by Minerva Surgical. Read More

Medtronic Pays $2M to Settle Unlawful Marketing Suit

Devicemaker giant Medtronic has agreed to a $2.4 million settlement in a case at Massachusetts’ Suffolk Superior Court over claims about deceptively marketing its Infuse Bone Graft. Read More

Devicemakers in Puerto Rico Draw Ongoing FDA Attention

The FDA remains seriously concerned about shortages of certain medical products as manufacturers in Puerto Rico continue their slow recovery from Hurricane Maria, but the shortage of IV saline products should improve by the end of the year, Commissioner Scott Gottlieb said in his latest update. Read More

IV Bag Shortage Continues After Hurricane Maria Damage

The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said. Read More

Gottlieb: Puerto Rico Device Firms Still Operating Below Capacity

Helping to restore medical manufacturing in Puerto Rico has been the “highest priority” at the FDA since hurricanes Maria and Irma struck, Commissioner Scott Gottlieb told a congressional committee on Oct. 24. Read More

Medical Device Firms in Puerto Rico Still in Recovery Mode

Devicemakers in Puerto Rico continue to grapple with the widespread destruction left by Hurricane Maria. Read More