FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

Photo of Allison FultonPhoto of Keeley A. McCartyPhoto of Elizabeth Hummel*By Allison Fulton, Keeley A. McCarty and Elizabeth Hummel* on Posted in Coronavirus

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements. The transition periods, which would begin (in most cases) 180 days after the end of the public health emergency (PHE), would allow manufacturers, healthcare facilities, and other stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements. Manufacturers who do not wish to continue distribution post-PHE could keep business as usual through the end of the 180-day transition period. Comments on the draft guidance are due on March 23, 2022.  The guidance for EUA devices can be found here, and for devices marketed under COVID-19 enforcement policies, here.

Continue Reading

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

Photo of Allison FultonPhoto of Julia KadishPhoto of Cynthia SuarezBy Allison Fulton, Julia Kadish and Cynthia Suarez on Posted in Clinical Trials, Digital Health & Medical Devices

On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. Though largely directed to study sponsors using DHTs, the guidance raises issues that developers and manufacturers of these technologies will want to be mindful of given the ways in which their products might be used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance can be accessed here.

Continue Reading

Waiver Of Intellectual Property Protections For COVID-19 Vaccine Unlikely To Have Meaningful Impact In Short Term

Photo of Lorna TannerPhoto of Thomas Carr*By Lorna Tanner and Thomas Carr* on Posted in Coronavirus, IP and Technology Transactions

On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many people as fast as possible.”[1] That goal, however, is unlikely to be affected by such a waiver in the short term due to uncertainty in World Trade Organization (“WTO”) politics, ongoing shortages on raw materials and equipment, and lag-time in retrofitting potential manufacturers. Continue Reading

FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

Photo of Allison FultonPhoto of Eva SchifiniBy Allison Fulton and Eva Schifini on Posted in Biotechnology, Clinical Trials, Coronavirus, Enforcement Actions, Prescription and OTC Drugs

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations.  For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other safety issues.  For the long term, the agency likely will employ the remote monitoring strategies it has implemented during the pandemic and expand its remote data collection capabilities to preserve resources and curb in-person inspections. Continue Reading

Breaking Down FDA’s New Remote Monitoring Strategy

Photo of Allison FultonPhoto of Eva SchifiniBy Allison Fulton and Eva Schifini on Posted in Biotechnology, Clinical Trials, Coronavirus, Enforcement Actions, FDA, Prescription and OTC Drugs

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered under the bioresearch monitoring (BIMO) program; and (3) outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).  The evaluations do not replace in-person inspections, and FDA Form 483s will not be issued as a result of the inspection, but the results could be used to support regulatory actions, such as approving a pending product application.  Continue Reading

New State Genetic Privacy Law Directed at Consumer Genetic Tests

Photo of Allison FultonPhoto of Julia KadishBy Allison Fulton and Julia Kadish on Posted in Digital Health & Medical Devices, FDA, Legislation

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer (DTC) genetic testing companies. Companies distributing DTC tests should evaluate their current data privacy policies and practices against the obligations the new Utah law imposes on data use and protection, including user consent, data security, and access and deletion rights, to ensure they are in a position to comply with the new law. Continue Reading

FDA Announces Facility Fees for OTC Drug Manufacturers

Photo of Allison FultonPhoto of Theresa ThompsonBy Allison Fulton and Theresa Thompson on Posted in Prescription and OTC Drugs

On Friday, March 26, 2021, FDA published a Federal Register notice,  “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC) monograph drug user program.  This is the first year that FDA has collected user fees from OTC drug manufacturers and submitters of OTC monograph order requests under its new authority under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.  With limited exceptions, all manufacturers of OTC drugs must pay a facility fee, which exceeds $20,000, by May 10, 2021 (45 days after publication of the notice). Continue Reading

Recent FTC Settlement Serves as Reminder For Digital Health Developers

Photo of Liisa ThomasPhoto of Julia KadishPhoto of Allison FultonBy Liisa Thomas, Julia Kadish and Allison Fulton on Posted in Digital Health & Medical Devices, Enforcement Actions

Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While potentially outside the scope of HIPAA, developers in this space are reminded of the risks stemming from other federal and state privacy and security laws, including unfair or deceptive abuse acts and practices (UDAAP) laws. A recent Federal Trade Commission (“FTC”) settlement sheds light on the importance of accurately describing how information is collected, used, and shared. Continue Reading

FDA Appointment Signals Increased Attention on Medical Device Cybersecurity

Photo of Allison FultonPhoto of Julia KadishBy Allison Fulton and Julia Kadish on Posted in Digital Health & Medical Devices

At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s role also includes a one-year appointment with the Digital Health Center of Excellence (DHCoE), a division launched in September 2020 within CDRH.  Many see this new appointment as an indication that the Agency will make cybersecurity a priority in 2021. Continue Reading

LexBlog

By scrolling this page, clicking a link or continuing to browse our website, you consent to our use of cookies as described in our Cookie and Advertising Policy. If you do not wish to accept cookies from our website, or would like to stop cookies being stored on your device in the future, you can find out more and adjust your preferences here.

Agree