Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
7/17/2025
/ CLIA ,
Clinical Laboratories ,
Compliance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medical Research ,
Regulatory Requirements
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
Cutting-edge technology is desirable to consumers for its ability to deliver innovative solutions, improved efficiency, enhanced user experiences, and the promise of staying ahead in an ever-evolving digital landscape. The...more
11/28/2023
/ Artificial Intelligence ,
Clinical Laboratory Testing ,
Compliance ,
Cybersecurity ,
Durable Medical Equipment ,
Health Technology ,
Healthcare ,
Innovation ,
Payment Systems ,
Popular ,
Reimbursements ,
Telemedicine
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
10/5/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Biotechnology ,
Chief Compliance Officers ,
Compliance ,
Connected Items ,
Consent ,
Continuing Legal Education ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Security ,
Durable Medical Equipment ,
EU ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Medical Devices ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Physicians ,
Regulatory Requirements ,
Risk Management
In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
12/2/2022
/ Clinical Trials ,
Compliance ,
Continuing Legal Education ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Documentation ,
Draft Guidance ,
EU ,
European Data Protection Board (EDPB) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Individual Accountability ,
International Data Transfers ,
Labeling ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Park Doctrine ,
Popular ,
Public Health ,
Regulatory Violations ,
Reporting Requirements ,
Risk Management ,
Schrems I & Schrems II ,
SCOTUS ,
Separation ,
Standard Contractual Clauses ,
Transparency
Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more
9/29/2022
/ AdvaMed ,
Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Enforcement ,
Ethics ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Government Investigations ,
Healthcare Workers ,
Hospitals ,
Internal Communications ,
Open Payments ,
Settlement ,
Speaker Programs ,
Supremacy Clause ,
Transparency ,
Value-Based Care