GHTF Has Acted; Now Industry Must
Global harmonization is no longer a buzzword, but a reality. The Global Harmonization Task Force (GHTF) has developed a number of guidance documents, and many of them are starting to be implemented. GHTF chairman Larry Kessler, who is also director of CDRH’s Office of Science and Engineering Laboratories, took some time with MD&DI to assess the GHTF’s progress. His thoughts appear as a Q&A in our January issue.
There are now systems that enable nations with developed regulatory systems to share audits and adverse event reports, and to accept certain kinds of premarket applications from the same form. In turn, these systems could well be adopted by nations with less-developed regulatory systems, so they don’t have to start from scratch. This is a remarkable achievement, because for years it was unclear just how eager the regulators around the world were for true harmonization.
But Kessler is not content for the GHTF to sit on its laurels. In his comments to MD&DI, he identifies some areas that need work. In particular, he is concerned about industry’s commitment. “I believe industry has not come to the table in terms of submitting [applications in the Summary Technical Documentation format] and volunteering for multipurpose audits,” he said. “They have not used the opportunities that some regulators have provided, and that makes moving forward with harmonization difficult.”
So now it’s up to you, industry, to take this process to the next level. If there are concerns that potential effects of harmonization could be bad for business, now is the time to air them. If there is an unwillingness to take advantage of what has been put in place so far, now is the time to explain why. Otherwise, the harmonization effort could be derailed, or implemented in a way industry doesn’t want. And there is too much at stake for that to happen.
Join MD&DI’s Reader Board
Take control of MD&DI's content! Your participation in a monthly online survey can help shape the look, feel, and content of the magazine. We also want your opinion on topics of importance to the industry. Team up with MD&DI by filling out this form. We can’t wait to hear from you!
A Comprehensive Guide to the Quality System Regulation
By Kristin Miller and William Hyman
A thorough understanding of FDA’s quality system regulation is crucial for medical OEMs.
Trends in Device Packaging
By William Leventon
New developments on the packaging front further protect medical devices from damage and contamination.
Exploring Market for Better Operating Models
By Tom Hodson, Tom Beatty, Ohad Ludomirsky, and Kelly Fischbein
The future of medical device firms could hinge on four significant market trends.
Special Section: Machining
The Advantages of Photoetching
By John Daniel
Photoetching can be a useful technique for treating special materials.
Making the Most of Laser Ablation
By Glenn Ogura
Medical OEMs can harness laser ablation for their polymer-based devices.
Magnetoelectropolishing Metallic Implants
By Ryszard Rokicki, Tadeusz Hryniewicz, and Krzysztof Rokosz
Electropolishing is taken a step further with a constant magnetic field.
Coupling Simulation Software Tools for Implants
By Metin Ozen, Can Ozcan, and Kaan Divringi
Using Ansys and AnyBody in tandem can provide a reliable prediction of device performance.
Improving Devices with Micro Flex Circuits
By Luke Volpe
Reductions in conductive trace width and pitch have opened the door for miniature-scale microcircuits.
The Benefits of Systems Thinking
By Timothy Bowe
OEMs can deal with increasing device sophistication by using systems thinking for testing software-based devices.
More from this issue of MD&DI