FDA’s Initiative for Protecting Women’s Health

by Nikita Angane | May 13, 2021 | FDA, Healthcare, Mammograms, Quality, Women, Women's Health

National Women’s health week is a week-long observance by the US Department of Health and Human Services’ Office on Women’s Health. The week of May 9^th-15^th, 2021 is a reminder from the HHS to all the women and the girls of the country to make their health a priority, especially in the current health crisis the country has been facing.

Women’s health has been a top priority of the HHS and its agencies, especially the FDA. FDA’s Office of Women’s Health, established in 1994 serves as the principal advisor to the FDA Commissioner and other officials on issues relating to women’s health.

The office focuses on building a robust regulatory framework for products including drugs and devices that treat or diagnose women. The Office also fosters research and development initiatives through OWH funded research projects.

One such initiative was the Mammography Quality Standards Act (MQSA); which amends the Part 900 Regulations. This action was taken to address changes in the mammography technology and mammography processes that have been in existence since 1997 and to address appropriate health information reporting to the patient and health care providers. Under the MQSA program, the inspection process which is enhanced by the ‘Enhancing Quality Using the Inspection Program’ (EQUIP) initiative, adds inspection questions related to existing regulations about image quality, thus ensuring that the inspection covers all aspects of product quality.¹

This allows for new steps to be taken to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care. These changes will improve the quality of mammography allowing for more informed medical decision-making thus taking one step closer to protecting women’s health.

As a woman-owned business, EMMA International prides itself in helping women researchers and entrepreneurs bring their products to market and bring diversity within the supply chain of American corporations.

EMMA International is here to assist you with all your quality and regulatory needs, call us today at 248-987-4497 or email us at info@emmainternational.com to learn more.

¹FDA(May 2021) Mammography Quality Standards Act and Program retrieved on 05/09/2021 from https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.