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

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

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

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

There's one decision that comes up again and again in US market entry projects: treating the choice of US Agent like a quote comparison. "It's just an address on a form — might as well go with whoever's cheapest." From a working-level perspective, that's a perfectly reasonable call. The problem is the assumption behind it. If a US Agent's job really were nothing more than renting out an address, that would be the right choice. But look at the actual responsibilities FDA regul

In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Curren

You can no longer approach the FDA without an eSTAR. To launch a medical device in the U.S., entering the FDA’s gateway is an absolute necessity. For most companies, the preferred route is the 510(k), or Premarket Notification process. While primarily designed for Class II (moderate-risk) devices, it also applies to certain low-risk or high-risk devices depending on their unique technical characteristics. In fact, the vast majority of medical devices entering the U.S. market

The First New FDA Sunscreen Ingredient Addition in More Than 20 Years The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new FDA sunscreen ingredient addition to the OTC sunscreen monograph since the late 1990s. The decision represents an important regulatory milestone for the U.S. sunscreen industry and may create new opportunities for product innovation in the years ahead. What Is Bemot

Last May, the FDA officially announced a recall of a kimchi brand sold in the U.S. The product itself wasn't the problem. What triggered the recall was a single missing line on the label — the anchovies used in the product weren't declared as an allergen the way FDA requires. Over 32 million Americans live with food allergies. And undeclared allergens are one of the violations the FDA treats most seriously. U.S. Allergen Rules Are Stricter Than Most Brands Expect The FDA reco

The Hidden Labeling Risks American Beauty and Inner Beauty Brands Are Missing When preparing to enter the US market, most brands fixate on FDA registration and MoCRA compliance. Once the ingredient list is formatted according to regulation and the label design is set, it is easy to assume you’re in the clear. However, a significant portion of the lawsuits that actually threaten brands in the US market do not originate from the FDA. Instead, they stem from class-action lawsuit

A patient arrives in the ER. The medical team needs to quickly identify an implant placed years ago. Or a recall notice lands at a hospital — and no one can immediately tell whether the devices on the shelf are affected. This isn't hypothetical. It happens. The FDA's answer to this problem looks, on the surface, like just another barcode requirement. But it's something much bigger: the UDI (Unique Device Identification) system. And for any company selling — or planning to sel

Longevity: Shifting the Language of Beauty In the U.S. beauty market this year, the term "anti-aging" is rapidly fading from brand vocabularies. In its place, "Longevity" has taken center stage. Longevity is no longer just about living longer; it’s about "how long one can maintain a state of peak health." This encompasses an entire lifestyle—from exercise, sleep, and diet to stress management and skincare—aimed at slowing down aging at a cellular level. With Mintel identifyin

On March 5th, the FDA released a significant update that carries substantial weight for the industry. The agency has finalized a rule to unify the National Drug Code (NDC)—the identification number for all drugs sold in the U.S.—from the current 10-digit format to a standardized 12-digit format. Read More : Final Rule "Revising the National Drug Code Format and Drug Label Barcode Requirements" Why FDA's NDC Matters Every product classified as a drug in the U.S. must have an

A fast-growing K-Beauty brand — call it Brand A — recently appeared in not one but two FDA public databases. First in CAERS, the FDA's cosmetics adverse event reporting system. Then in MAUDE, the medical device adverse event database. No recall. No import alert. But showing up across two separate FDA systems at the same time? That kind of thing gets noticed. Why an FDA Database Listing Is Never Just a Footnote CAERS and MAUDE are fully public. No login required. Any consumer,

The Shifting Landscape of K-Beauty: From ‘Topical’ to ‘Ingestible’ Global consumer research identifies the most significant shift in the recent beauty market as the expansion of beauty concepts—moving from "what you apply" to "what you consume." Consumers no longer see skincare as the exclusive domain of topical cosmetics; instead, they have begun to integrate dietary supplements and wellness products into their daily skincare routines. At the heart of this paradigm shift lie

The Next Frontier for K-Beauty: The Rise of "K-Beauty Devices" The global phenomenon of K-Beauty is no longer confined to skincare and cosmetics. By combining innovative ingredients and fast-paced trends with advanced technology, a new wave of "K-Beauty Devices" (or K-Devices) is rapidly gaining traction in the U.S. This category spans from at-home skin management devices and LED masks to MedSpa-inspired home-care tools that treat the face, scalp, and body simultaneously. U.S

Gen Z is a generation that values the meaning conveyed over the visual appearance . For them, the functionality of a product is as important as its packaging, labeling, and communication style aligning with their personal values. Eco-friendly packaging, refillable containers, understated text, and an unboxing experience worthy of sharing on social media—all these factors are becoming selection criteria for beauty products just as crucial as the product itself. Why Gen Z Emph

Gen Z: The New Core of the Global Beauty Market Gen Z (born 1997–2012) has firmly established itself as a pivotal consumer group in the global beauty market. Global consumer reports from BCG and McKinsey estimate their direct purchasing power at approximately $360 billion. Furthermore, they are recognized as an ‘Influential Consumer’ segment, significantly impacting the purchasing decisions of their peers and families. This generation maintains clear criteria for consumption.