Breaking Down FDA’s New Remote Monitoring Strategy

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

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

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

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

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

FDA’s Action Plan for Artificial Intelligence: Highlights and Insights for Developers

The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for AI and ML-based medical devices.  The quick takeaway is that FDA will publish a draft guidance on change control plans, a key concept from its April 2019 discussion paper on AI/ML-based software devices (previously reported here). FDA also will hold a public workshop on algorithm transparency and engage its partners and stakeholders on other key initiatives, such as evaluating bias in algorithms. While the Action Plan proposes a roadmap for advancing a regulatory framework, an operational framework appears to be further down the road. Continue Reading

FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence

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

This 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

On 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

On 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

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