FDA To Revise “intended use” Regulations In March 2018

FDA To Revise “intended use” Regulations In March 2018

Introduction

The FDA is proposing to delay the effective date of the amendments to the existing medical product “intended use” regulations to allow further consideration of the substantive issues raised in the comments received. As per the Federal Register of January 9, 2017, the final rule added a new regulation (§ 1100.5) to title 21 of the CFR to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The effective date of the final set rule was finally set as until March 19, 2018, as the FDA reopened the docket to invite additional public comment on the rule and will consider the comments submitted to prepare and publish a final notification of the delay.