FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” The document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a

This post was also written by Ruth N. Holzman, Angelo Ciavarella and Jennifer A. Goldstein.

On February 7, 2012, the Internal Revenue Service (IRS) published proposed regulations to implement the Affordable Care Act’s (ACA) 2.3% excise tax on the sale price of medical devices sold by the manufacturer, producer, or importer of the device after December 31, 2012. The ACA defines a taxable medical device as any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) that is intended for humans and is listed as a medical device with FDA (or should have been listed) by a registered medical device establishment excluding eyeglasses, contact lenses, hearing aids, and any other medical device of a type that is generally purchased by the general public at retail for individual use. The proposed regulations set forth the IRS’s interpretation of key elements of the excise tax, including the retail exemption.

Additional details are available after the jump.Continue Reading IRS Proposes Regulations to Implement ACA Medical Device Tax

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) issued draft guidance on August 15, 2011 to help researchers and manufacturers design better quality clinical studies in support of premarket approval applications for certain medical devices. Although the public can comment on the draft guidance at any time, FDA has requested