Regulatory/Legal
Three Former Execs Named in Criminal Indictment
Three former executives of Spectranetics are accused of illegally importing unapproved medical devices in a 12-count criminal indictment announced this week. Also named in the indictment, which was announced by Colorado U.S. attorney John Walsh's office, was a representative of a...
Has FDA Seen Your Facebook Yet?
The power of social media isn't lost on us. Apparently it isn't lost on FDA either. The agency recently went after a pharmaceutical company for using the Facebook Share function, which could be the first time FDA has warned a company for Facebook promotion. The problem? FDA says...
FDA Releases Proposals for 510(k) Improvement
FDA released a 120-page report late yesterday detailing proposed changes to the maligned 510(k) process. The report was split in two, with the first part addressing preliminary recommendations to improve the process. The second part is a separate report from a CDRH task...
Panel Supports Medtronic Implant
FDA's Orthopedic and Rehabilitation Devices Panel voted 6-5 in favor of Medtronic's new Amplify spinal implant. The device is designed to stimulate bone growth in patients who have had spinal surgery. Last week FDA voiced concerns about the number of cancer cases seen among...
St. Jude Keeping Its Legal Team Busy
St. Jude Medical has filed a patent infringement lawsuit against Volcano Corp. that accuses the company of infringing on key patents used for St. Jude's PressureWire interventional technology for its PrimeWire products. Both companies use an index called Fractional Flow Reserve...
FCC and FDA to Coregulate Wireless
The Federal Communications Commission and FDA signed a memorandum of understanding (MOU), agreeing that that the agencies will work together to create an efficient regulatory structure for wireless-enabled medical devices and services. The agreement has a five-year sunset...
White Paper on Combo Products and FDA Regs Released by Microtest
A free white paper guides medical device manufacturers in the process of applying new FDA regulations to combination products embedded with pharmaceutical or biologic components. In the paper titled, "Combination Products 2.0: Applying the New FDA Regulations," Steven...
Genetic Tests Count as Devices, says FDA
In letters sent last week, FDA told five companies it considers their personal genome services unapproved medical devices. 23andMe, Navigenics, deCODE Genetics, Knome and Illumnia were told that the companies that they should have submitted their tests to the FDA before offering...
MDMA Calls on Government to Support Innovation
Speaking at the 16th annual meeting of the Medical Device Manufacturer's Association (MDMA), the organization's president and CEO, Mark Leahey, stressed the importance of engaging both FDA and politicians. “If the United States is to maintain its leadership position in medical...
Lawmakers Ponder Transparency for Tax Credits
The state senate in Massachusetts is considering a measure that would disclose more information about the hundreds of millions of dollars in tax subsidies that go to medical device firms (as well as film companies, dairy farmers, and other businesses). Some of the information is...