Tele: 561.316.3330
Breaking Medical Device News

Tuesday, October 19, 2021



Better Job Titles – A Reflection Of Work Satisfaction

The recent inflation trend in job titles is something that is ringing alarm bells globally. So, what does it mean? Or, more importantly, do job titles really reflect work satisfaction? Keep reading to find out.

9 of the Highest Paying Travel Nursing Specialties

The highest paying travel nursing specialties tend to offer significantly higher pay rates and benefits than their non-traveling counterparts. Learn More.

Why Every Healthcare Organization Should Embrace A Lean Approach

Quality, efficiency, and safety determine the success of a business in any domain. The healthcare industry is not an exception. Rather, providers need to...

The U.S. Food and Drug Administration today announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency.

These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk.

“Foodborne illness outbreaks are largely preventable but can have devasting consequences for consumers,” said Erik Mettler, assistant commissioner for partnerships and policy in the FDA’s Office of Regulatory Affairs (ORA). “The FDA is committed to keeping Americans safe. As part of our commitment, we are using these partnerships to strengthen our relationship with our state regulatory partners and improve industry compliance with applicable food safety requirements to reduce foodborne illness outbreaks.”

These new mutual reliance agreements help the FDA to work in cooperation with the states of California, Florida, Utah and Wisconsin to rely on, coordinate with and leverage one another’s work, data and actions to achieve a safer national food supply. As envisioned in the FDA Food Safety Modernization Act (FSMA), the Partnership for Food Protection and the New Era of Smarter Food Safety blueprint, the mutual reliance agreements will enhance the existing relationships with states and government counterparts, moving the nation toward an Integrated Food Safety System.

“A strong, integrated system is essential to a safe food supply. Mutual reliance between the FDA and individual states is one example of the many actions the agency is taking to address our nation’s increasingly complex food production and distribution systems,” said Michael Rogers, assistant commissioner for the Office of Human and Animal Food Operations in the FDA’s ORA. “We expect that as more states sign mutual reliance agreements, it will help reduce redundancy and duplication of effort, optimize the impact of our collective oversight, and allow us to build on the long-standing relationships that we have with our state regulatory partners. This is truly a step forward towards achieving a seamless integrated food safety system between the federal and state regulators.”

The FDA will collaborate with partner states on data sharing, risk prioritization, inspections, outbreak investigations, development and monitoring of key metrics and laboratory capacity, among many other key focus areas. The domestic mutual reliance framework provides opportunities for the FDA and partners to jointly identify needs to better protect the public and leverage work from other regulatory programs. In addition, it will provide knowledge to build quality management systems and infrastructures to support national regulatory standards, including those related to resource allocation, training, outreach and information exchange.

FSMA was signed into law in 2011 and enables the FDA to focus on the prevention of foodborne illness rather than relying primarily on reacting to problems after they occur. The Act provides the FDA with authority to achieve higher rates of compliance with prevention and risk-based food safety standards. In addition, the FDA has the authority to better respond and contain food safety concerns when they do occur.

Additional Resources:



HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

Alpha Tau Receives FDA’s Breakthrough Device Designation for the RX of Recurrent Glioblastoma Multiforme

"As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA's Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients.

FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin

These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk.

Our Sister Publication: Biotechnology News Magazine

By using this website you agree to accept Medical Device News Magazine Privacy Policy