The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance, regulatory documents, communications and other public documents.
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as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.
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.
Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.
Medtech and Biotech companies that prioritize professional development and career growth can reduce turnover and attract new talent. Here is how one company is standing out in a highly competitive employment market.
Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.
Many younger employees need the interaction of in-person work. But to encourage a broader return to in-person work, organizations must make a compelling case for the benefits it brings employees. At the same time, they need to toss out the old office paradigm and transform to one that celebrates the new world of work.
There is capital sitting on the sidelines, but founders and CEOs should realize that investors are digging into their due diligence. The “wow” factor and potential size of the medtech market matter much less now than solid fundamentals.
The COVID-19 pandemic exposed the necessity of virtual care and revealed its possibility as a more efficient means of administering treatment in an overwhelmed and understaffed infrastructure. Its fast-paced adoption highlighted the need for global standards and third-party certifications.
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.
