The Medical Imaging & Technology Alliance (MITA) testified before the U.S. House Energy and Commerce Health Subcommittee last week, offering the industry's perspective on the proposed FDA Globalization bill.
Elisabeth George, vice president of quality, regulatory, sustainability and product security at Philips Healthcare and MITA board member, testified on behalf of MITA, encouraging Congress to facilitate global harmonization of safety standards by mandating International Standards Organization (ISO) 13485 certification, rather than instituting new inspections.
“Our members’ foreign and domestic facilities are subject to international quality and safety inspections at least annually as part of the ISO 13485 standard. This inspection is virtually identical to the FDA Quality System Regulations inspections,” George said. “The FDA should avail itself of the valuable information gained from these inspections.”
In addition to supporting global harmonization for the safety of medical imaging technology, George also shared concerns about duplicative and unnecessary provisions in the FDA Globalization bill as currently drafted. Specifically, she addressed the industry's apprehension about the mandated new inspections for nearly every modification in a medical device, required registration and inspection of each medical device component, and new fees that would place an unfair burden on domestic medical imaging manufacturers, all of which could unduly stall delivery of improved technology to the U.S. healthcare system and limit patients’ access to important preventive screenings and diagnostic procedures.
“We understand that there are significant concerns about the drug ingredients and food that have been imported from foreign countries. However, we believe the device industry, a highly regulated industry globally, is vastly different,” said George, highlighting the unique nature of how medical imaging devices are manufactured and regulated.
“The equipment our member companies manufacture empowers doctors and medical professionals to view the human body with stunning, and ever increasing, clarity and accuracy. This enables better diagnoses and more effective medical care for patients, often reducing the need for costly medical services and invasive surgical procedures,” George said.
MITA is a division of the National Electrical Manufacturers Association (NEMA).