Medical Device Legal News with Sam Bernstein: Episode 11
On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...more
In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
Sixty years after the discovery of polymetallic nodules and thirty years after the establishment of the International Seabed Authority (“ISA”), deep-sea mining could be licensed as early as July 2023. The ISA is expected to...more
The Information Commissioner’s Office published draft guidance on privacy enhancing technologies that can be used to comply with privacy-by-design requirements. On 7 September 2022, the Information Commissioner’s Office...more
On January 18, 2022, the European Data Protection Board (the "EDPB") issued the Guidelines 01/2022 on data subject rights - Right of access (the "Draft Guidelines"), laying out its interpretation of Article 15 GDPR on the...more
On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more
The US State Department is soliciting feedback on its draft “US Government Guidance for the Export of Hardware, Software, and Technology with Surveillance Capabilities and/or Parts/Know-How,” issued September 4, 2019 (Draft...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In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs.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