Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Another Survey Shows US Regulatory Structure Undermining Innovation

A new survey conducted by Northwestern University and funded by the Institute for Health Technology Studies (InHealth), a nonprofit research institute whose board consists of AdvaMed, Johnson & Johnson and Stryker executives, finds that smaller medical device manufacturers are favoring Europe over the US for product commercialization at an increasing rate.

Based on online responses from more than 350 medical device professionals, the survey shows that 80% of respondents chose to approach EU regulators first to discuss and plan device submissions, while four percent of respondents opted to approach the FDA as their first regulator of choice.

The survey’s device-specific section furthermore showed that 65% of respondents’ devices attained CE Marking before 510(k) clearance; US review times typically take twice as long as EU processes, the survey indicated.

A broad majority (76%) of respondents large and small reported finding FDA 510(k) preparation and submission requirements unclear; that percentage bears particular significance given that 98% of respondents cited predictability of regulatory requirements as a key factor in whether to undertake new product development efforts.

The survey found that smaller-tier medical device manufacturers are significantly impacted by delayed and protracted FDA review processes. Product development efforts for smaller firms take an average of nearly 27 months compared to about 18 months for larger manufacturers with more resources at their disposal. Along with longer product development time frames come longer FDA review times: Smaller firms reported average review times of 330 days, whereas larger firms reported 177-day review periods. Considering that smaller manufacturers have been responsible for developing some of the more cutting-edge devices and technologies, regulatory processes that stifle their paths to market can only lead to a “brain drain” in the US, argue the survey authors.

In order to better support innovative product development in the US market, the survey authors prescribe a familiar remedy: stronger collaboration between industry and regulators as well as more consistency in establishing and enforcing regulatory requirements.

Markets: USATags: CDRH, EU, FDA, InHealth, innovation

Author: Stewart EisenhartDate: May 24, 2011

New Program Could Halve PMA Processing Time for Innovative Devices

In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program, the Innovation Pathway, to prioritize and potentially expedite reviews of breakthrough devices.

Under the new program, the FDA could begin premarket reviews of qualifying devices within 150 days, half the time it now takes the agency to process premarket approval applications. In order to participate in the Innovation Pathway program, a device must include technology considered “truly pioneering” and able to revolutionize health care delivery. The manufacturer must be able to meet development roadmaps and timelines set by the Center for Devices and Radiological Health (CDRH); qualifying devices would also be assigned case managers and possibly be allowed more flexible clinical trial protocols.

Major features of the Innovation Pathway will include a voluntary third-party certification program for US medical device test centers, a core curriculum available to the public for medical device development and testing, and greater use of data and experience gathered in other countries.

Another component of the program—“formal horizon scanning”—entails the CDRH systematically monitoring literature and funding in order to predict new medical device technology developments.

A new oversight entity, the Center Science Council, is currently being formed to review Innovation Pathway applications.

The Innovation Pathway’s pilot submission, a brain-controlled prosthetic device developed by the Defense Advanced Research Projects Agency (DARPA), has been announced along with the program’s rollout. Manufacturers of high-risk or novel devices will no doubt monitor the pilot to gauge whether the new program does indeed prove more efficient than current the current PMA process.

The CDRH has begun soliciting public comment on the Innovation Pathway program, and plans a March 15 public meeting on the topic.