healthcarecompliance

In December 2023, two US senators raised concerns, urging the government to scrutinize the FDA's oversight of medical device recalls, notably amidst the ongoing Phillips Respironics recall.

Join us today as we delve into the world of medical device recalls. Facing a recall is every manufacturer's nightmare, but handling it right is paramount. It safeguards patients, preserves reputations, and sidesteps legal nightmares.

Educate Yourself: The first step? Knowledge is power. Familiarize yourself with FDA guidance – understanding what you can, should, and must do. Develop policies consistent with this guidance to fortify your approach.

Transparency Is Key: Building trust is pivotal. Be upfront with the FDA when necessary. Clear, concise communication lays the foundation for swift and effective action.

Meticulous Planning: Plan with precision. Consider logistics and support. Identify affected devices, create a comprehensive notification strategy, and establish clear instructions for replacement or return. A well-thought-out plan is your best defense.

Legal Support Matters: Recalls happen, but with the right legal partner, you can minimize the impact. The Kulkarni Law Firm is here to help you navigate recalls with reassurance, ensuring the protection of your patients and your business.

Trust the Kulkarni Law Firm to guide you through the maze of medical device recalls, ensuring minimal scars and maximum protection. The path to a well-managed recall starts here.

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies entering the clinical trial recruitment space, advising careful assessment of their experience and disease state knowledge. He also suggests that while this trend is emerging, its ultimate impact remains uncertain. Additionally, he concludes by encouraging those in need of assistance with training, policy development, or gap analyses to contact Darshan Kulkarni at darshan@kulkarnilawfirm.com