FDA Issues Draft Guidance on Sex/Gender Data in Medical Device Studies and Optical Imaging Drugs
Key Insights
The FDA released draft guidance emphasizing the importance of considering sex and gender in medical device clinical studies, updating its 2014 guidance to include gender-specific data.
New draft guidance provides recommendations for drug companies on designing clinical trials for optical imaging drugs used during surgery to detect tumors (search) or delineate anatomical structures.
The FDA finalized guidance on action levels for lead in processed foods for babies and young children, aiming to reduce dietary exposure to lead and support the 'Closer to Zero' initiative.
The Food and Drug Administration (FDA) has released a series of guidances to provide clarity and recommendations to the pharmaceutical and medical device industries. These guidances cover a range of topics, from evaluating sex- and gender-specific data in medical device clinical studies to developing drugs for optical imaging.
Sex- and Gender-Specific Data in Medical Device Clinical Studies
The FDA issued a draft guidance titled "Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies." This guidance encourages a science-driven approach to considering sex and gender in the design of medical device clinical studies and the reporting of data. The goal is to ensure that both sex and gender are appropriately addressed, aligning with the scientific question and the device's intended use. This draft, once finalized, will update the 2014 guidance, "Evaluation of Sex-Specific Data in Medical Device Clinical Studies," by incorporating gender-specific data. The FDA is accepting comments on this draft guidance until April 7, 2025.
Developing Drugs for Optical Imaging
Another draft guidance issued by the FDA focuses on "Developing Drugs for Optical Imaging." This guidance offers recommendations to drug companies on designing clinical trials for optical imaging drugs. These drugs are used with imaging devices during surgical procedures to detect tumors (search) or other pathologies, or to delineate normal anatomical structures. The guidance aims to streamline the development process for these specialized drugs, ensuring their effective and safe use in surgical settings.
Action Levels for Lead in Processed Food
In addition to the draft guidances, the FDA finalized guidance on "Action Levels for Lead in Processed Food Intended for Babies and Young Children." This guidance supports the FDA's "Closer to Zero" initiative, which seeks to reduce dietary exposure to contaminants, including lead, in foods for young children. FDA Deputy Commissioner for Human Foods Jim Jones stated, "The FDA's guidance for industry is a major step in our commitment to driving down dietary exposure to contaminants like lead in foods intended for babies and young children to as low as possible while maintaining access to nutritious food."
Other Guidances
The FDA also issued a final guidance, "Guidance for Industry (GFI) #294: Animal Food Ingredient Consultation (AFIC)", a draft guidance, "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway", a draft guidance, "Study of Sex Differences in the Clinical Evaluation of Medical Products", and a draft guidance with the Office for Human Research Protections, "Considerations for Including Tissue Biopsies in Clinical Trials."