Medical Device Legal News with Sam Bernstein: Episode 11
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
On July 16, 2024, the California Privacy Protection Agency (the “CPPA”) board declined to advance to formal rulemaking California Consumer Privacy Act (“CCPA”) draft regulations on cybersecurity audits, risk assessments,...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more
FTC Settles with Experian for Alleged Customer Spamming - On August 14, 2023, the Federal Trade Commission (“FTC”) announced a proposed settlement involving Experian Consumer Services (“Experian”). A federal court entered...more
Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more
The EPA has release a proposed guidance document for conducting cumulative risk assessments (“CRA”) under the Toxic Substances Control Act (“TSCA”). The guidance is designed to assist the EPA to characterize and quantify the...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
Following in the footsteps of its international counterparts, the Australian Prudential Regulation Authority ("APRA") is ramping up its guidance on the management of climate-related risks. On 22 April 2021, APRA released...more
In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more
On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more
On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft...more
The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015. ...more
In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which...more
On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more
In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more