We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 32

Food, Drug and Device Law Alert - FDA Makes Revisions to Two Medical Device Application Process Documents
  • Barnes & Thornburg LLP
  • USA
  • February 5 2018

The FDA recently issued two revised final medical device guidance documents titled, “Refuse to Accept Policy for 510(k)s” and“Acceptance and Filing


Food, Drug and Device Law Alert - Lengthy ‘Medical Device Reporting for Manufacturers’ Guidance Issued By FDA
  • Barnes & Thornburg LLP
  • USA
  • November 18 2016

The Food and Drug Administration (FDA) recently issued a lengthy final guidance titled "Medical Device Reporting for Manufacturers." The guidance


Food, Drug and Device Law Alert - FDA Extends Compliance Dates for Certain Final Rules Under the Food Safety Modernization Act
  • Barnes & Thornburg LLP
  • USA
  • August 26 2016

The Food and Drug Administration (FDA) recently issued a final rule extending certain compliance dates for some of the foundational final rules


Food, Drug and Device Law Alert - FDA Updates Benefit-Risk Determinations for New Medical Devices
  • Barnes & Thornburg LLP
  • USA
  • August 26 2016

The Food and Drug Administration (FDA) recently issued a final guidance titled, “Factors to Consider When Making Benefit-Risk Determinations in


Food, Drug and Device Law Alert - FDA Revises 2011 Draft Guidance on New Dietary Ingredients for Supplements
  • Barnes & Thornburg LLP
  • USA
  • August 24 2016

The Food and Drug Administration (FDA) recently issued a revised version of the draft guidance titled, "Dietary Supplements: New Dietary Ingredient


After 19 Years, FDA Issues Final Rule on GRAS Notices
  • Barnes & Thornburg LLP
  • USA
  • August 22 2016

The Food and Drug Administration (FDA) recently issued a final rule that amends and clarifies the criteria for when the use of a substance in food


FDA Publishes Final Rule on Use of Stand-Alone Symbols in Medical Device Labeling
  • Barnes & Thornburg LLP
  • USA
  • June 27 2016

The Food and Drug Administration (FDA) recently issued a final rule on the use of stand-alone symbols (i.e., symbols not accompanied by explanatory


FDA Issues Draft Guidance on Benefit-Risk Factors to Consider Regarding Medical Device Availability, Compliance, and Enforcement
  • Barnes & Thornburg LLP
  • USA
  • June 21 2016

The Food and Drug Administration (FDA) recently issued a brief draft guidance titled "Factors to Consider Regarding Benefit-Risk in Medical Device


FDA Issues Draft Guidance on Disseminating Patient-Specific Information from Medical Devices
  • Barnes & Thornburg LLP
  • USA
  • June 13 2016

The Food and Drug Administration (FDA) recently issued a brief draft guidance titled "Dissemination of Patient-Specific Information from Devices by


Is It Juice or Sugar? Use of ‘Evaporated Cane Juice’ in Food Labels Criticized by FDA
  • Barnes & Thornburg LLP
  • USA
  • June 3 2016

The Food and Drug Administration (FDA) recently issued a final guidance for food manufacturers on the use of the term "evaporated cane juice" on food