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FDA Warning for Kim Kardashian
A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog….
Regulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings…
FDA Microneedling Regulations Status Update
Befuddled and Confused – Microneedling and the FDA One of the most common questions received in our office is whether a product is “FDA Approved.”…
510k Exempt Medical Device Guidance
510k Exempt Medical Device Guidance New Guidance Expands Class I and II Exemption to Devices Previously “Unclassified” or “Reserved” New 510 Exempt medical device Guidance…
Electronic and Radiological Devices Accession Numbers
Electronic and Radiological Devices Accession Numbers Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer…
FDA SEC Reporting – Regulatory Reviews for SEC Forms
FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…
FDA Regulation of Homeopathic Drugs – Meeting Foreshadows Changes
FDA Regulation of Homeopathic Drugs Current Regulation of Homeopathy The FDA currently regulates homeopathic drugs under a 1988 Policy Guide. The Policy Guide is detailed…
Nutrient Content Claims + KIND Warning Letter
What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of the KIND snack bar with a recent…
FDA Warning Letters
The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters are common food,…
FDA Regulatory Status Call
Managing Engagement with the US FDA to Avoid Penalties One of the most challenging aspects of working with the FDA is engaging directly with the…