JNP Medi Hosts Webinar on Food and Drug Administration (FDA) Approval Strategies for Medical Devices

[Financial News] JNP Medi held a webinar on FDA regulatory approval strategies to help South Korean medical device companies enter the U.S. market.
On the 23rd, JNP Medi said that at its recently held first online webinar, Keith Christopher, director of U.S. regulatory affairs, explained FDA medical device classifications and the differences among the main regulatory pathways: 510(k) Premarket Notification, De Novo, and PMA. Christopher worked as an FDA lead reviewer for about six years.
In particular, he emphasized using the FDA's pre-submission program, Pre-Submission, early in product development to review regulatory pathways and submission materials in advance. This could help reduce scheduling delays and additional costs that may arise during the review process, the company explained.
JNP Medi plans to hold a second webinar on Dec. 9, where it will cover additional practical information on FDA medical device regulatory approvals. Details on how to participate will be available on the company's official website.
JNP Medi is a company that supports the development, clinical trials, regulatory approval, and commercialization of new drugs and medical devices, drawing on its clinical trial data management platform and regulatory strategy consulting services.

[email protected] Sang-hee Jeong Reporter