FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for October 2016

Posted on Friday, October 21 2016 at 6:56 pm by -

Forty Years in the Making — FDA Issues Propose Rule Requiring Electronic Submission of Labeling and Package Inserts for Class II and Class III Home-Use Medical Devices

By: Carolina M. Wirth

This past summer, the Food and Drug Administration (FDA or Agency) celebrated the 40th anniversary of the enactment of the Medical Device Amendments of 1976, which in part amended Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add requirements for the registration of device manufacturers and the listing of medical devices.  As enacted, the statute also required that the listings be accompanied by copies of the device label.[1]   However, because the registration and listing information was required to be provided in paper form for many years, FDA did not enforce the requirement that medical device establishments submit labeling information because “there was no practical way for FDA to compile, update, or access the information submitted on these forms, much less provide routine public access to the information.”[2]  Therefore, FDA decided to require by regulation that medical device manufacturers maintain a historical file of labels, labeling, and advertisements for restricted devices, and “make all or part of that file available to FDA upon request.”[3]  This practice has remained in place since a final rule was issued in 1978.

In 2002, Congress began to recognize the impact of the internet when it passed the Medical Device User Fee and Modernization Act, providing FDA with the authority to collect registrations and listings “at such time as FDA determined it was feasible . . . . through electronic means.”[4]  Amendments to the Medical Device User Fee Modernization Act in 2007 finally made the submission of registration and listing information by electronic means mandatory in all instances, unless a waiver is granted by the Agency.

Now, almost 10 years after the requirements for electronic submission of registration and listing information, FDA is issuing a Proposed Rule amending its regulations to require the electronic submission of the label and package insert for certain “home-use” medical devices when the devices are listed with FDA.[5]  The Proposed Rule defines a “home-use” medical device as “a medical device that is labeled for use in any environment outside a professional health care facility.”[6]  The types of “home-use” devices that would be subject to the Proposed Rule, if finalized, are those that are regulated by FDA as Class II or Class III devices, which are considered moderate-to-high risk medical devices.[7]


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Posted on Thursday, October 13 2016 at 6:53 pm by -

FDA’s Hatch-Waxman Regulations Get a Long Overdue Update

By: Alyson L. Wooten, Pharm.D.

On December 5, 2016, twenty-two (22) pages of new Hatch-Waxman regulations will be codified in the Code of Federal Register. These new regulations bring several significant changes to the Hatch-Waxman landscape, which has been largely unchanged for over a decade.

The Final Rule,[1] titled “Abbreviated New Drug Applications and 505(b)(2) Applications” (Final Rule) was published in the Federal Register twenty (20) months after the Food and Drug Administration (FDA or Agency) published the Proposed Rule, which outlined Agency’s plan for implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).[2]

Specifically, the Final Rule implements portions of the MMA that pertain to:

  • Notices provided to the patent owners and the new drug application (NDA) holder for certain patent certifications made in 505(b)(2) applications or ANDAs;
  • The availability of 30-month stay of approval for 505(b)(2) applications or ANDAs that are otherwise ready to be approved;
  • Submission of amendments and supplements to 505(b)(2) applications and ANDAs; and
  • The types of bioequivalence and bioavailability data that may be used to support 505(b)(2) applications or ANDAs.


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Posted on Saturday, October 1 2016 at 1:57 pm by -

FDA Seeks to Redefine the Term “Healthy” and Questions Whether this Could Help Consumers Make Better Food Choices

By: Carolina M. Wirth

Getting consumers to make informed food choices and encouraging the food industry to develop healthier foods continues to be a priority for the Food and Drug Administration (FDA) as the Obama administration comes to an end. After publishing a Final Rule updating the Nutrition Facts panel and serving sizes for some foods for the first time in over 20 years in May[1] of this year, FDA is now turning to redefining the term “healthy” as a nutrient content claim.

Currently, FDA regulations (21 C.F.R. § 101.65(d)) establish parameters for the use of the implied nutrient content claim “healthy” on the labeling of a food to suggest that the food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations.[2]  The parameters include (1) specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, and sodium; and (2) requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber.[3]  While the nutrient criteria for using the term “healthy” can vary for different food categories, they are specifically linked to the elements in the Nutrition Facts panel and serving size regulations.[4]


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