The Food and Drug Administration (FDA) requests comments on a draft guidance document titled “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.” When finalized, the guidance is “intended to provide greater clarity on FDA’s decisionmaking process.” Comments are requested by November 14, 2011.  

The Food and Drug Administration (FDA) issues draft guidance titled “Design Considerations for Pivotal Clinical Investigations for Medical Devices.” Developed for industry, clinical investigators and agency staff, the document, when finalized, will “provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions.” Comments are requested by November 14, 2011.

The U.S. Department of Agriculture schedules a public meeting of the Advisory Committee on Biotechnology and 21st Century Agriculture on August 30-31, 2011, in Washington, D.C. Topics will include practical approaches to bolster coexistence among different agricultural production methods.

The Food and Drug Administration announces the availability of guidance titled “E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.” The guidance intends to “create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.”

The Food and Drug Administration seeks public participation in a September 15, 2011, meeting in Silver Springs, Maryland, to consider the recommendations proposed in the Institute of Medicine’s report, “Medical Devices and the Public’s Health, the FDA 510(k) Clearance Process at 35 Years.” The agency requests written public comments on the report’s recommendations by September 30, 2011.