Guidance includes information about what’s protected—and what is not—when using period trackers and other health information apps on smartphones.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.
The upcoming revision to ISO 10993-17 proposes the use of release kinetics data to support toxicological risk assessments. Manufacturers should expect that this data will be needed to help mitigate the risks identified in exhaustive extraction studies.
FDA CDRH Announces Reopening for All IVD Pre-Submissions
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
The AHRQ brief proposes a framework to assess the risk/safety, technical functionality and mental health features of apps. The framework can be used by advocacy organizations, payers, healthcare systems and others to inform selection of mental health mobile apps.
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.