Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

• Urgent, Urgent, Urgent … Emergency: FDA Advises Companies to Issue Appropriate Product Recall Warnings 
• FDA Provides Guidance on How to Formally Request Informal Feedback on Product Designation from the Office of Combination Products 
• You Can’t Put That Tissue There: FDA Clarifies Important HCT/P Regulatory Criteria 
• Commissioner Agrees Industry Is No Beast of Burden; Provides Plan to Improve Least Burdensome Approach
• Medical Device Industry Gets Yet Another MDET Reprieve

PHARMACEUTICALS

Urgent, Urgent, Urgent … Emergency: FDA Advises Companies to Issue Appropriate Product Recall Warnings
By: Alan G. Minsk and Elizabeth A. Mulkey

Channeling the rock band Foreigner and its 1981 hit, “Urgent” (or the Beatles’ “Get Back” single), the Food and Drug Administration issued a draft guidance in January 2018, cautioning industry to properly warn the public about product recalls … or else. This draft guidance was issued one month after a report from the Office of Inspector General for Department of Health and Human Services (OIG) on FDA’s food recall process, which found deficiencies in FDA’s oversight of recall initiation and monitoring. While the draft guidance is not legally binding, it reflects the agency’s current thinking and is worth reviewing. This Bulletin will highlight FDA’s recommendations and offer AGG observations. More > 

FDA Provides Guidance on How to Formally Request Informal Feedback on Product Designation from the Office of Combination Products
By: Deborah L. Livornese

Earlier this month, the Office of Combination Products of the Food and Drug Administration issued a final guidance for industry, How to Prepare a Pre-Request for Designation (Pre-RFD). The final guidance does not vary significantly from the draft, and it provides not only useful information for industry on how to submit a request and what to include, but also sets forth FDA’s intent to respond within 60 days and describes the internal review process. More > 

You Can’t Put That Tissue There: FDA Clarifies Important HCT/P Regulatory Criteria
By: Alan G. Minsk and Kalie E. Richardson

One of the first warning letters of 2018 was issued to a manufacturer of a human cell, tissue, and cellular and tissue-based product (HCT/P) that the Food and Drug Administration said was regulated as a drug, and as a biological product, and required a biologics license because it did not meet the definitions of minimal manipulation and homologous use. The meanings of these two terms are the subject of a new guidance FDA issued in November 2017. The guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (Guidance), provides clarification on these two criteria that are used to determine how an HCT/P will be regulated by FDA. More >

DEVICES

Commissioner Agrees Industry Is No Beast of Burden; Provides Plan to Improve Least Burdensome Approach
By: Deborah L. Livornese and Elizabeth A. Mulkey

The concept of “least burdensome” review is not new. Starting with the FDA Modernization Act of 1997 (FDAMA), the Food and Drug Administration has been directed to take the “least burdensome approach” to the premarket evaluation of medical devices – i.e., to minimize unnecessary burdens to industry while maintaining the regulatory standards for clearance or approval of devices. What is new is FDA’s updated commitment to focus on employing a “least burdensome” approach in its reviews. In response to a recent GAO report on FDA’s implementation of the “least burdensome” requirements, FDA Commissioner Scott Gottlieb issued a statement explaining how FDA is modernizing its approach to medical device regulation. Commissioner Gottlieb’s statement echoes the themes of CDRH’s 2018-2020 Strategic Priorities, which were also released in January 2018. More >

Medical Device Industry Gets Yet Another MDET Reprieve
By: Damian M. Hovancik and Kalie E. Richardson 

When the short-lived government shutdown ended on January 22, so did this year’s implementation of the 2.3% medical device excise tax (MDET). The tax was to be effective on January 1, 2018 and the first payment to the Treasury Department would have been due by January 29, 2018. The stopgap spending law retroactively delayed implementation of the tax and extended the moratorium until the end of 2019. The MDET is now set to go into effect on January 1, 2020. More >