Improving FDA Reviews of Combination ProductsAn industry study recommends five changes for intercenter consultations
Tue, 11/24/2015 - 16:55
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by… FDA’s 510(k) Guidance Emphasizes Software-as-Device FactorNew guidance is more specific about acceptance criteria for software
Thu, 09/24/2015 - 12:15
The path to medical device commercialization requires FDA approval, which most often means filing a premarketing notification, also known as a 510(k). The FDA has specific criteria for accepting a 510(k), and it just released its new acceptance… Cybersecurity—A Real Threat to Medical DevicesSafeguards must be implemented to protect patients
Mon, 08/24/2015 - 12:36
The FDA just issued a Safety Communication on the cybersecurity vulnerabilities of the Hospira Symbiq Infusion System, which is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. The… Avoid Common Medical Device Software Development PitfallsIEC 62304 provides a common framework to fulfill requirements
Tue, 06/16/2015 - 17:02
IEC 62304, the international standard that defines software development life-cycle requirements for medical device software, was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a… It’s Time to Get IEC 62304 Before It Gets YouCompliance is determined by a review of all required documentation, including risk management
Wed, 09/24/2014 - 10:50
Food and Drug Administration (FDA) medical device recalls are on the rise. An increasingly active FDA coupled with an increase of medical device software components is adding up to new challenges for manufacturers. It’s important to understand how… Time to Take a Closer Look at FDA MDDS MovesDown-classifying medical device data systems may put the public at risk
Wed, 08/06/2014 - 15:12
The FDA recently released a new draft guidance document for medical device data systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify…
