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The FDA is proposing a voluntary program to speed the approval of medical technologies that address unmet needs for life-threatening and irreversibly debilitating diseases. Read More
Sponsors of new medical technologies must include a description of any pediatric subpopulations that suffer from the condition the product is intended to treat. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two CDRH device branches, under an experimental program announced Thursday. Read More
The FDA may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by other factors such as postmarket controls, the agency says in draft guidance published Wednesday. Read More
Women now have an additional option for cervical cancer screening with the FDA’s Thursday approval of an expanded indication for a human papillomavirus diagnostic. Read More
The FDA Tuesday proposed a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More