In the second quarter of 2014, the U.S. Food and Drug Administration has issued eight draft and final guidance documents related to medical device manufacturers and marketers.
Compiled by The National Law Review, here are those draft and final guidance documents, starting with the most recent.
1. Global Unique Device Identification Database
On June 27, the FDA released the finalized guidance for medical device labelers on how to establish and use a GUDID account and maintain a unique device identifier. The UDI compliance requirements begin Sept. 24, 2014.
2. Social Media
On June 18, the FDA issued a draft guidance regarding medical device and pharmaceutical companies' social media use. According to the draft guidance, such companies must include risk information and benefit claims in all online postings about their products, even on Twitter where they are limited to 140 characters.
3. Voluntary Consensus Standards in Premarket Submissions
The FDA's draft guidance issued May 13 discusses the appropriate use of voluntary consensus standards during the premarket review process. The guidance outlines proposed policy changes regarding declarations of conformity.
4. Pediatric Uses of Medical Devices
This final guidance, issued on May 1, outlines the type and scope of information entities must submit for premarket approval applications for pediatric uses of medical devices.
5. Live Case Presentations
The FDA's draft guidance issued April 17 outlines the agency's regulations and policies related to live case presentations using investigational devices in complex surgical procedures during clinical investigations of devices.
6. Devices Meeting Unmet Needs
On April 23, the FDA issued a draft guidance regarding Expedited Access Premarket Approval Applications for medical devices meeting unmet medical needs for life-threatening diseases. The draft guidance suggests more engagement with FDA staff to collaboratively collect data necessary for product approval, thereby expediting the timeline for patients to access such devices. It also outlines eligibility for the proposed program.
7. Pre- and Postmarket Data Collection
Also on April 23, the FDA issued a draft guidance discussing balancing premarket and postmarket data requirements for facilitating device development and review. Specifically, the draft guidance outlined how postmarket information can help support premarket approval in a number of scenarios.
8. Communication During Submission Reviews
The FDA's final guidance issued April 4 outlines new communication "commitments" during the device review process to increase its transparency.
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