…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…
…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…
…between using these sensors to track sleep for self-betterment and using them make medical decisions,” – Michelle S. Keller, MPH, Cedars-Sinai Center for Outcomes Research and Education. The study did,…
…between using these sensors to track sleep for self-betterment and using them make medical decisions,” – Michelle S. Keller, MPH, Cedars-Sinai Center for Outcomes Research and Education. The study did,…
Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The violations include…
Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The violations include…
Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…
Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…
The medical device industry did not ring in the New Year with good news. Just a month ago, the industry thought it was close to yet another suspension, but instead,…
The medical device industry did not ring in the New Year with good news. Just a month ago, the industry thought it was close to yet another suspension, but instead,…
…the hopes and aspirations that come with the rebirth of a year. As the device industry greets the New Year, there are significant regulatory challenges on the horizon. For example,…
…the hopes and aspirations that come with the rebirth of a year. As the device industry greets the New Year, there are significant regulatory challenges on the horizon. For example,…
…the obligation to obtain a certification for all prescription support software and dispensation support software. Claimants have put forward that the certification requirement does not comply with European law since…
…the obligation to obtain a certification for all prescription support software and dispensation support software. Claimants have put forward that the certification requirement does not comply with European law since…
…and critical part of the medical device design process.” The free product selector tool asks a series of specific questions to generate a list of suitable medical adhesives for the…
…and critical part of the medical device design process.” The free product selector tool asks a series of specific questions to generate a list of suitable medical adhesives for the…
…today. Proton beam systems are currently only made by foreign manufacturers, and cost between $30-$50 million per system. However, Chinese companies are investing in foreign manufacturers. In 2015, proton therapy…
…today. Proton beam systems are currently only made by foreign manufacturers, and cost between $30-$50 million per system. However, Chinese companies are investing in foreign manufacturers. In 2015, proton therapy…
Beginning today, FDA will choose up to nine applicants for a new Voluntary Medical Device Manufacturing and Product Quality Pilot Program. “The FDA believes that proactive engagement with medical device…
Beginning today, FDA will choose up to nine applicants for a new Voluntary Medical Device Manufacturing and Product Quality Pilot Program. “The FDA believes that proactive engagement with medical device…
