Out of EUA— FDA Guidance and Recommendations

Описание: In our webinar held last July about the FDA’s Emergency Use Authorization (“EUA”), presenter Jianlin Song predicted that, as we get closer to the end of the pandemic, the FDA would release guidelines to help the industrial players transition their products from the temporary EUA pathway to its traditional regulatory schemes. The guidelines are finally out—in December 2021, the FDA published two Draft Guidance Documents containing transition plans for medical devices that either issued EUAs or fall within any related enforcement policies to return to normal operations and foster compliance with the applicable regular policies. Public comments are to be submitted before March 23, 2022.

In this webinar she reviews the agency’s recommendations in these two documents and discusses what companies and insurers should expect in the next few months.

Jianlin Song | Partner | Wilson Elser

Jianlin Song, MD, JD, is a Partner in the Life Science Litigation Group at Wilson Elser Moskowitz Edelman and Dicker LLP’s San Francisco office. During her 15 years of legal practice, Dr. Song has defended manufacturers of a broad spectrum of life science products, from food supplements and dental adhesives to prescription drugs and Class II medical devices such as joint replacements, electroconvulsive therapy devices and cold therapy devices. She has also defended diagnostic laboratories, fertility centers, and various medical, dental and psychiatric professionals in malpractice cases. Among her many successes, Dr. Song won a motion for summary judgment for the manufacturer of a 3D-printed joint prosthesis in what was likely the first products liability case against a 3D device in California.

In addition to litigation, Dr. Song counsels small businesses, both domestic and international, on pre- and post-marketing compliance issues. She has helped companies from various parts of Asia bring hand sanitizers and other PPEs onto the United States market during the COVID-19 pandemic.