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.
The catheter is part of the company’s transcatheter pulmonary valve system.
FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
