medicaldevicesafety

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Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.

The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of these features.

Design-related recalls take center stage in the FDA's recommendations. The agency discourages choosing a predicate device that has been subject to a design-related recall. If a submitter opts for such a device, they must explicitly address how they've mitigated the safety concerns that led to the recall.

Transparency and documentation constitute the third crucial consideration. The FDA stresses the need for a detailed 510(k) summary that provides a comprehensive understanding of the basis for determining substantial equivalence.

The guidance encourages the inclusion of a narrative explanation in the 510(k) summary. This narrative should elucidate the process behind selecting the predicate device, offering transparency and insight into the decision-making process.