by Methodize | Apr 18, 2016 | FDA
The increasing clout of hospital General Purchasing Organizations (GPOs), insurers and other large payers in US medical device purchasing and reimbursement may be hindering innovation, R&D and quality issues in the relentless effort to drive down healthcare...
by Jack Slovick | Feb 19, 2016 | FDA
Today, the Food and Drug Administration (FDA) released a draft guidance document, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” Medical...
by Mick Schulte | Feb 6, 2016 | FDA
Today, the FDA’s Center for Devices and Radiological Health (CDRH) issued the final version of the guidance, “Applying Human Factors and Usability Engineering to Medical Devices.” This guidance will assist medical device developers in following appropriate human...
by Jack Slovick | Aug 28, 2015 | FDA
Are you ready for September 24, 2015? In just over a month, several categories of Class I and II devices will reach their compliance due date for labeling requirements under the Unique Device Identification (“UDI”) regulations. For companies with implantable,...
by Jack Slovick | Aug 5, 2015 | FDA
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency. The latest RTA...
