News & Blog

Provision Consulting Group was honored to participate in the American Conference Institute (ACI) Conference on Legal, Regulatory, and Compliance Issues in the Cosmetics and Personal Care Industry, where our Co-CEO, Mr. Sung Kwon, was invited to speak alongside leading attorneys, regulatory professionals, corporate counsel, and industry experts. The ACI conference is widely recognized as an important forum for professionals working across the legal, regulatory, compliance, cos

There's a quiet hope that keeps circulating among medical device companies eyeing the US market. "Maybe the next round of reforms will finally speed things up." Application volume keeps climbing while the reviewer headcount stays flat, so the thinking goes that the next policy overhaul has to bring some relief. The signal FDA just sent points the other way. Not faster. Tighter. MDUFA Isn't Just a Fee Schedule — It's a Five-Year Deal Between FDA and Industry Getting a device o

This is the second post in a series covering recurring FDA Import Alert patterns by industry. Part 1 covered food and dietary supplements; this one covers medical devices. Read More:: Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements Even companies with a 510(k) clearance sometimes find their shipments held at customs — and this question keeps coming up in medical device inquiries. Clearance and the ability to actually clear customs a

This post is the first in a series on recurring FDA Import Alert patterns by industry. This installment covers food and dietary supplement cases; the next covers medical devices. Read more:: Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices Three days after his container cleared Busan and reached the Port of LA, the exporter got a frantic call from his U.S. buyer. Customs wouldn't release the shipment. The paperwork from FDA mentioned someth