Provision Consulting Group

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Provision Consulting Group We offer streamlined solutions to complex procedural issues affecting U.S. FDA-regulated industries.

Provision Consulting Group Inc., located in East Los Angeles, is an FDA regulatory compliance company and CRO specializing in the medical device, cosmetic, food, and drug industries. We are committed to providing a full range of consulting services in the areas of pharmaceutical, medical device, and biologics regulatory compliance.

08/24/2026

Companies preparing to enter the US medical device market should take note of a recent FDA announcement.FDA has finalized the FY2027 medical device user fees in the Federal Register. The new rates run from October 1, 2026 through September 30, 2027.On the surface, this looks like a routine annual no...

08/14/2026

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 so...

08/03/2026

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 SupplementsEven companies with a 51...

07/27/2026

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 something called "DWPE" — the product had been detained automatically, no physical inspection requir...

07/21/2026

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 t...

06/30/2026

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, ...

06/23/2026

The First New FDA Sunscreen Ingredient Addition in More Than 20 YearsThe 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.T...

06/16/2026

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 America...

06/12/2026

The BIO International Convention, taking place in San Diego from June 22–25, is one of the world's leading events for the biotechnology and life sciences industry. Every year, the convention brings together biotechnology companies, pharmaceutical developers, investors, research institutions, manuf...

06/02/2026

Lately, the FDA has been issuing a wave of Warning Letters to OTC sunscreen manufacturers. Korean manufacturers are no exception. Across all these letters, the core issue remains exactly the same: It’s not just about a faulty product; the entire manufacturing quality system is failing to function....

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