CDRH Chief Shuren Warns of Medical Device ‘Perfect Storm’

Addressing the state of his agency and the device industry, CDRH director Jeffrey Shuren said, “We’re in the midst of a ‘perfect storm,’ and I don’t know where we’ll come out.” Shuren cited the following pressures and constraints:

Shuren made the remarks at the Food and Drug Law Institute’s 54th annual meeting in April. He said that U.S. medtech firms are “still leaders in product innovation, but [they] may not remain so.”

Elaborating on the increasing complexity of CDRH-regulated products, Shuren highlighted the many product categories that did not exist even a few years ago, including robotics, miniature devices (such as products incorporating nanotechnologies), wireless devices, personalized medicine devices, mobile technologies, and complex devices designed to be used in the home and other venues outside of healthcare settings.

Shuren said CDRH now reviews over 9000 submissions annually, including more than 4000 with user-fee performance goals specified by the Medical Device User Fee and Modernization Act (MDUFMA). He did note that 95% of those MDUFMA-related goals are being met. Further, Shuren said meetings with sponsors of investigational device exemptions (IDE) have doubled, while imports of regulated products increased 10% per year between 1998 and 2008. 

According to Shuren, the ideal medical device industry ecosystem would be composed of strong companies, a strong research component, and a strong FDA. Shuren said that, as part of its role in that ecosystem, FDA must increase the predictability, consistency, and transparency of premarket reviews and facilitate the development of innovative new technologies.

With regard to meeting demand for the latter, Shuren mentioned the innovation pathway CDRH is developing for the accelerated review of pioneering technologies. He said the agency intends to establish public-private partnerships to help create new tools for device development, including test centers where early feasibility studies and flexible clinical trials may be undertaken.

With regard to postmarket surveillance, Shuren said CDRH has taken steps to enhance the Medical Product Safety Network (MedSun) surveillance system and is performing data-mining studies to detect safety signals from information in medical device reporting (MDR). He also pointed out two registries that have been established as part of a postmarket surveillance effort: a breast implant registry, established in collaboration with the American Plastic Surgery Society, to identify rare breast cancers, and an orthopedic implant registry, developed in cooperation with an international consortium.

Efforts to boost compliance include a single audit initiative, which was designed to facilitate reciprocity among regulators in a globalized environment. Shuren said a pilot project in cooperation with Canadian regulatory body Health Canada is underway. Inspectors will work off of the same inspection standards and report in ways that are useful to all participating regulators.

While speaking at the University of Minnesota Design of Medical Devices Conference later in April, Shuren reiterated CDRH’s efforts to encourage innovation. He didn’t break any new ground in outlining the center’s initiatives to foster innovation. Observers said he reviewed the proposed new pathway for moderate-risk medical devices, creation of a center science council to oversee clinical studies and related science, and an initiative to reach out to other federal agencies on common issues.

For its part, AdvaMed submitted formal comments on CDRH’s innovation pathway on April 11, 2011. AdvaMed said it appreciates that FDA is taking steps to foster innovation and improve American competitiveness but believes CDRH’s innovation proposal should apply to a broader range of devices.

The association argued that more than one or two devices per year can be counted as innovative. It said FDA’s priority should be to facilitate development and regulatory evaluation of innovative medical devices by minimizing delays and ensuring that regulatory requirements are applied consistently. 

“CDRH could quickly expand the proposed priority review program to expedited devices and devices approved through its humanitarian device exemption pathway and then ultimately expand the program to all devices,” the commentary read. The group supports expediting the review of important groundbreaking technologies. But, it said, before investing limited agency resources in developing a new and resource-intensive pathway for a limited number of devices, CDRH should focus on refining and quickly incorporating the expedited review process so that the initiative is successful.

FDA Publishes 30-Day Notice Guidance Document

FDA has published a guidance document on 30-day notices, 135-day premarket approval (PMA) supplements, and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes. The document is meant to update guidance on the topic that the agency provided in 1998. The new guidance reflects the current review process, gives additional examples of manufacturing changes that may be submitted under this program, and includes a discussion of user fees.

The guidance notes that if FDA finds a sponsor’s 30-day notice of manufacturing changes that affect safety or effectiveness inadequate, it will tell the applicant that a 135-day PMA supplement or 75-day HDE supplement must be submitted. FDA says this guidance makes clear which kinds of changes the agency believes may qualify for the 30-day notice and which kinds of changes that generally will not qualify.

FDA Recalls Penumbra’s Coil 400 System

On April 13, FDA announced the Class I recall of Penumbra Inc.’s Penumbra Coil 400 system, which includes a tool used to implant coils inside a patient. FDA said the pull wire on the delivery tool can slip out of place and allow the coil’s premature detachment, which “may cause the coil to unintentionally migrate.” According to the agency, “this can lead to serious injury, including blood clots and stroke.”

FDA described the device as a small platinum coil that is placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.

The FDA announcement said that on March 4, Penumbra Inc. notified its customers and distributors of the recall and instructed them to return the product to the company. The agency encouraged people to report adverse events to the agency via its MedWatch program.

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