Excise Tax The United States Food and Drug Administration

News & Analysis as of

Omnibus Tax Bill Passes the House. On to the Senate.

After two days of debate HB 1050 - Omnibus Tax Changes passed the House. (Bills that raise revenue must be have 2nd and 3rd readings on separate days)....more

Tax Talk -- Volume 6, No. 3 -- October 2013

In This Issue: A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...more

FDA Scrutinizes Mobile Medical App – Intriguing Letter to App Developer Precedes Expected Release of Final Guidance

On May 21, 2013, the Food and Drug Administration (“FDA”) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited, the developer of the uChek Urine Analyzer app. The app, available since April...more

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

Beginning January 1, 2013, manufacturers and importers of certain medical devices will be required by the U.S. Internal Revenue Service (IRS) to pay a new 2.3 percent medical device excise tax on the sales of taxable medical...more

Foley Hoag and AdvaMed Collaborate on Industry Guidance on Retail Exemption in Final Device Tax Regulations

Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more

IRS Releases Final Rule on Medical Device Tax

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

IRS Issues Final Regulations Implementing the Affordable Care Act’s Medical Device Excise Tax

On December 5, 2012, the Internal Revenue Service (IRS) published final regulations regarding the implementation of the excise tax applicable to the sale of certain medical devices, enacted by the Patient Protection and...more

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