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A Year in Review: FDA Drug and Device Regulations in 2016

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.