Posts by Marc Sanchez
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 was issued on July 1 by the US Food and Drug Administration. Prior to the 510k exempt medical device Guidance Document a certain group of medical devices were either deemed…
Read MoreElectronic 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 to the unique FDA identifiers for electronic product reports found in FDA’s radiation emitting electronic product database. The accession number is provided in response to mandatory reporting for electronic and radiolgoical…
Read MoreFDA 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 call “cosmeceuticals”), or medical devices. This is because it is not often the case where FDA regulation and law overlaps or impacts the Security and Exchange Commission. One of the…
Read MoreFDA Label Review – Overview and Tips
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 with labeling instructions, definitions, and other requirements. Yet it is also striking simple. It holds that if a drug is approved
Read MoreNutrient 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 Warning Letter. The Warning Letter cites KIND for failing to following the heavily regulated category of claims known as “nutrient content claims.” This has left some wondering whether the FDA…
Read MoreNew FDA Expedited Access Pathway Program
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, dietary supplements, cosmetics, drugs, medical devices, biologics (including clinical and pre-clinical research), veterinary medicine (food, supplements, drugs), and tobacco products (cigarettes and e-cigarettes). The FDA views Warning Letters as serving…
Read MoreFDA 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 FDA. In particular when the topic of discussion is potential enforcement action, such as a Warning Letter or Recall. This is often the case for a FDA Regulatory Status Call.…
Read MoreFDA Regulation of Personal Lubricants
GNC to Strengthen Supplement Quality Controls – Implications for Suppliers
The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the New York State attorney general’s office. New testing procedures will be rolled-out over the next 18-months. The new program will have lasting implications for the numerous suppliers of GNC private…
Read MoreFDA Food Contact Formulation Notification Guidance
FDA Food Contact Formulation Notification Guidance FCF Overview FDA food contact formulation (FCF) notification guidance plays an important role in determining regulatory status of components of a Food Contact Material. Many industry professionals may be surprised to learn the FDA regulates food packaging. Food packaging is considered an indirect food additive. Determining the regulatory status…
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