The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health and health care.
As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.
“Many medical device and life sciences companies are still carrying out manual validation processes, using paper-based scripts, screen shots and pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”
The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
The two new final guidances are intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and post-approval study requirements.
On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and machine learning expands throughout industry and online.
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
