On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations. In its current form, the regulations have created long-standing confusion as to whether mere knowledge of an unapproved use of an approved product (i.e., off-label) automatically triggers a new “intended use,” for which clearance or approval is required. The proposed rule clarifies that knowledge alone of off-label use would not create a new intended use, but confirms the Agency’s long-standing position that “any relevant source” of evidence (including knowledge) may be used to determine intended use. Comments on the proposed rule are due within 30 days unless FDA grants an extension. Continue Reading
FDA Update: The Latest on Vaccine Development, Inspections, and Conducting Clinical Trials During Covid-19
Posted in CoronavirusThis week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response to COVID-19, including the latest on vaccine development and facility inspections. FDA also issued an updated guidance on conducting clinical trials during COVID-19, showing its willingness to continue to adapt its policies to facilitate remote patient access during COVID-19. Continue Reading
Latest Update on FDA’s Software Pre-Cert Pilot Program
Posted in Digital Health & Medical Devices, FDAOn September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program. It is the only public update on the program in 2020. According to the update, FDA will continue to evaluate its Pre-Cert program, which currently is only in pilot form. Perhaps disappointing to many companies, the update did not suggest that FDA will be adding new participants to the pilot program at this time, nor did it signal that the program would be fully operational anytime soon. Continue Reading
FDA Announces Plans to Resume Domestic On-site Inspections
Posted in CoronavirusOn July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20. The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume. Under the rating system, facilities in areas where cases of COVID-19 are under control can expect to be inspected sooner than facilities in areas where COVID-19 cases are on the rise. Continue Reading
FDA Issues Guidance on Manufacturing Drugs, APIs during COVID-19
Posted in Coronavirus, Prescription and OTC DrugsFDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them. FDA is not aware of any drugs that have been contaminated with SARS-CoV-2, but the guidance provides the agency’s expectations for limiting potential contamination. While the FDA has not yet resumed routine facility inspections, and therefore likely will not actively monitor implementation of the risk assessments (or other suggestions in the guidance), manufacturers should consider the recommendations in the guidance to protect the public health and health of their employees.
Navigating FDA Policies for PPE, and Liability Protections
Posted in CoronavirusThe US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19. The Agency has articulated its guidelines for PPE in one of two ways: (1) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types. EUAs have the benefit of potentially providing manufacturers, distributors, and users of PPE with broad liability protections under the Public Readiness and Emergency Preparedness (PREP) Act (so long as the requirements and conditions of the EUA and the PREP Act declaration are met). Continue Reading
Not So Fast – FDA Retracts Authorization for Some Respirators Made in China
Posted in Coronavirus, Digital Health & Medical DevicesImmunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.
FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests
Posted in CoronavirusOn May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19. The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA. Under the previous policy, commercial test developers could distribute their tests without FDA authorization. The change in policy reflects growing concerns over the reliability of antibody tests currently on the market. The policy shift also suggests that manufacturers of medical supplies subject to relaxed enforcement policies during COVID-19 should monitor policy developments to confirm the regulatory status of their products. Continue Reading
April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies
Posted in Coronavirus, Digital Health & Medical DevicesAs reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, and equipment to treat respiratory failure. Continue Reading
Upping Hospitals’ Liability Defenses For COVID Measures
Posted in Coronavirus, Digital Health & Medical DevicesThis article originally appeared in Law360 on April 13.
The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic. Continue Reading
