Tag Archives: Draft

Now Hear This: FDA Issues Draft Guidance on Public Warning and Notification of Recalls

By Ricardo Carvajal — FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here).  Although the draft guidance extends to recalls of … Continue reading

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FDA releases 2017 enforcement statistics and recall draft guidance

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, … Continue reading

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CDRH Issues New Draft Least Burdensome Guidance

By Allyson B. Mullen — Section 513 of the Federal Food, Drug, and Cosmetic Act requires FDA to consider the least burdensome means of evaluating device safety and effectiveness for Class III devices and substantial equivalence for devices requiring 510(k) … Continue reading

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Are Only Two Types of Tests in Clinical Studies – Legally Marketed or Investigational? Maybe, according to FDA’s Draft Guidance for Investigational IVDs

By Allyson B. Mullen & Jeffrey N. Gibbs — On December 18, FDA released its draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” This is the latest guidance from the Agency on the relationship between in vitro diagnostic … Continue reading

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Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of … Continue reading

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