Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel | FDA

Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel | FDA

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being. Coronavirus Disease 2019 (COVID-19)

FDA and CDC take action to increase access to respirators, including N95s, for health care personnel In a joint effort, the FDA and the Centers for Disease Control (CDC) and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. [03/02/2020]

FDA Announcement FDA Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior After careful consideration, the FDA published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. [03/04/2020] FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast The FDA announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever). The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis. [03/04/2020]

Guidance Documents The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers  This guidance is intended to provide answers to common questions about FDA’s implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) on March 23, 2020 (the transition date). [03/04/2020]

Recall and Safety Information SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices The FDA is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited - may introduce risks for certain medical devices. SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to “pair” and exchange information to perform their intended functions while preserving battery life and can be found in medical devices as well as other devices, such as consumer wearables and Internet of Things (IoT) devices. These cybersecurity vulnerabilities may allow an unauthorized user to wirelessly crash the device, stop it from working, or access device functions normally only available to the authorized user. [03/03/2020]

Consumers Feed Your Mind is our new education initiative to help consumers better understand genetically engineered foods, commonly called GMOs or genetically modified organisms. GMO foods have been available to consumers since the early 1990s. Since then, the FDA, U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) have worked together to ensure that crops produced through genetic engineering are safe for people, animals, and the environment.  Despite there being a wide range of foods—GMO and non-GMO—available to consumers, there is some confusion around what GMOs are and how they are used in our food supply. To help increase consumer understanding of GMOs, in 2017, Congress provided funding for an Agricultural Biotechnology Education and Outreach Initiative, which calls upon FDA to work with EPA and USDA to share science-based educational information about GMOs, beginning with answers to some basic GMO questions. [03/04/2020] Public Meetings and Workshops Patient-Focused Drug Development (PFDD) for Vitiligo Date: March 30, 2020 Time: 1:00 PM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The FDA is interested in hearing patients’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. Register: If you wish to attend in-person or via webcast, please register at Eventbrite. Food and Drug Administration’s Communications About the Safety of Medical Devices Date: April 1, 2020 Time: 8:30 AM - 4:30 PM ET  Location:FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The goal of this public meeting is to share the FDA’s current practices about medical device safety communications, and to hear from our stakeholders (including patients and caregivers, healthcare providers, regulated industry, and media) about how we can improve our safety communications to assure they receive the information they need in a timely, clear, and consistent manner.  Register: If you wish to attend this public meeting, you must register here, by 4:00 P.M. ET on March 18, 2020. For a more comprehensive list of pubic meetings involving the FDA, please visit here