The FDA renewal period for medical device establishments runs October 1 – December 31, 2026. This includes your U.S. Initial Importer. FDA fee for FY2027: $13,785 per establishment Initial importers must register and pay FDA’s annual establishment registration fee, just like manufacturers. By designating Provision as your Initial Importer, you avoid setting up and paying for your own initial importer registration. Why does this matter? Every foreign-made medical device sold i

FDA requires every registered drug establishment to renew every year between October 1 and December 31. That window is open now. FDA fees for FY2027 Registration renewal and listing certification: FDA does not charge for the renewal itself. OMUFA facility fee (OTC monograph drug facilities only): Monograph Drug Facility (MDF): $47,891 Contract Manufacturing Organization (CMO): $31,927 This is about a 149% increase from FY2026 ($19,188 and $12,792). It is paid in two installme

FDA Food facility registration is renewed every two years, in even-numbered years. 2026 is a renewal year, and the window is October 1 – December 31, 2026. Renewal requires your facility’s DUNS information to match your registration exactly, and some facilities must submit additional attestations. Who needs to renew? Every domestic and foreign facility that manufactures, processes, packs, or holds food for U.S. consumption, including dietary supplements. What happens if you m

The FDA annual registration renewal period for medical device establishments is open now and closes December 31, 2026. Who needs to renew? Not only manufacturers. Every FDA-registered device establishment must renew each year, including: Manufacturers and contract manufacturers Specification developers Relabelers and repackagers Contract sterilizers and remanufacturers Initial importers What happens if you miss the deadline? Your establishment registration lapses. Shipments c

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), has released its proposed guidance agenda for Fiscal Year 2027. While the agenda does not establish new legal or regulatory requirements, it provides an important view into the topics CDRH intends to prioritize for guidance development and publication. For medical device manufacturers planning U.S. submissions, particularly 510(k), AI-enabled software, and novel device

Provision Consulting Group is pleased to announce that Sung Kwon, CEO of Provision Consulting Group, will be participating as a speaker at Cosmoprof Asia Hong Kong 2026. Sung Kwon will join the session “K-Beauty 3.0: Asia’s Innovation Powerhouses Captivating Gen Z,” taking place on November 12 at the Hong Kong Convention & Exhibition Centre. Event Details Session: K-Beauty 3.0: Asia’s Innovation Powerhouses Captivating Gen Z Date: November 12, 2026 Time: 3:00–3:45 PM HKT (UTC

Artificial intelligence is rapidly moving into regulated manufacturing environments. Manufacturers are increasingly using AI to assist with regulatory research, SOP drafting, specifications, quality documentation, and other activities that traditionally required significant human effort. But where does the responsibility remain when AI is involved? A recent FDA Warning Letter to Purolea Cosmetics Lab provides a useful enforcement example. The Warning Letter, issued on April 2

A response to an FDA Form 483 is an important regulatory step. But it is not necessarily the end of the process. A recent FDA Warning Letter issued to Bausch & Lomb Inc. provides a useful example of how the agency evaluates corrective and preventive actions (CAPA)—particularly when the underlying problems involve sterile manufacturing, contamination control, facility design, and the quality system. The warning letter followed an FDA inspection of Bausch & Lomb's Tampa, Florid

The U.S. Food and Drug Administration (FDA) is beginning to make meaningful changes to the regulatory framework governing OTC sunscreen products. In 2026, the FDA took two significant actions involving OTC sunscreen active ingredients. In June, the agency added bemotrizinol (BEMT) to OTC Monograph M020—the first new sunscreen active ingredient added to the U.S. OTC sunscreen monograph in 20 years. In September, the FDA finalized an order removing PABA (aminobenzoic acid) and

K-Beauty has entered a different stage in the United States. The question is no longer simply whether Korean beauty brands can attract American consumers. Increasingly, the question is whether brands can build the regulatory, operational, and commercial infrastructure necessary to sustain that growth. That is why we are pleased to announce that Torriden has onboarded Provision Consulting Group to support its U.S. regulatory compliance. Who Is Torriden? Torriden is a Korean sk

At Provision Consulting Group, we know that regulatory consulting projects move fast — and staying on top of project status, deliverables, and communications shouldn't require an inbox full of email threads. That's why we're excited to announce the beta launch of the Provision Client Portal, a dedicated hub built exclusively for our clients. Why We Built This Our goal was simple: reduce repetitive back-and-forth communication and give clients instant access to the documents a

AI can search regulations.R.I.S.E. is built to understand how regulation actually works in the U.S. market. That distinction is at the heart of R.I.S.E. — Regulatory Intelligence Strategic Engine, Provision Consulting Group’s proprietary next-generation regulatory intelligence platform. Provision recently completed the development and implementation of R.I.S.E. to address a question that became increasingly important as our regulatory practice grew: How can we turn years of r