Category: FDA

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Share

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show no sign of slowing, as the number and type of medical device products that are connected to the cloud increase (thereby increasing the attack surface for hackers), and as hackers become more sophisticated. Indeed, in a September 2022 FBI Private Industry Notification, the FBI noted that around 53% of connected medical devices and other internet of things (IoT) devices in hospitals had known critical vulnerabilities. These vulnerabilities could allow hackers to direct medical devices to give inaccurate readings, administer drug overdoses, or otherwise endanger patient health.

In the past, the U.S. Food & Drug Administration (FDA) has urged manufacturers to take measures to ensure the cybersecurity of their products through non-binding guidance. On December 29, 2022, President Biden signed into law the $1.7 trillion Omnibus Appropriations Act, which provided the FDA with authority to require manufacturers to take cybersecurity protection measures as to medical devices that are brought to market through future pre-market submissions. See H.R. 2617 (117th Congress, 2021-2022), text available here.

Continue reading “The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers”

FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

Share

On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the Strategic National Stockpile. (https://www.fda.gov/media/138945/download) The FDA concluded, based on clinical trial data and the continuing failure of treatment guidelines to support use of CQ or HCQ to treat patients with COVID-19, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

Continue reading “FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity”

FDA Gives Guidance on Reporting Medical Device Shortages

Share

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery.  If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset.  The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.

The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act.  Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016.  While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.

Continue reading “FDA Gives Guidance on Reporting Medical Device Shortages”

Third Circuit Clarifies Next Steps in Fosamax Decision

Share

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.

Continue reading “Third Circuit Clarifies Next Steps in Fosamax Decision”

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions”

Share

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” This document provides information on how the FDA evaluates uncertainty and the appropriate extent of uncertainty in the benefit-risk determination for medical devices that are subject to premarket approval (PMA).

Continue reading “FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions””

The FDA Is in the Doghouse

Share

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019).

There have been numerous reports of lawsuits involving allegedly contaminated pet food filed against pet food manufacturers or distributors by pet owners claiming that they were deceived by pet food labels and suffered harm either as a result of paying a premium for the food or because their pets were sickened by the food. In contrast, on July 5, 2019, a raw pet food company, Lystn, LLC, brought a civil action against the FDA seeking declaratory and injunctive relief. The complaint challenges the FDA’s ability to enforce what Lystn characterizes as “a nationwide zero-tolerance standard for Salmonella presence in pet food that is unsupported by science and ultra vires of powers properly delegated to it by Congress.”

Continue reading “The FDA Is in the Doghouse”