SAN JOSE, Calif. – Proposed regulations from the U.S. Food and Drug Administration could create "an innovation wasteland," warned a medical electronics executive speaking at the BioMeDevice Forum here.
Expected changes to the FDA's 510(k) process used by the majority of medical devices could create "potentially devastating unintended consequences," said Kenneth Kleinhenz, vice president of regulatory affairs and quality assurance at Cytori Therapeutics (San Diego). The changes could slow down the approval process and chill already tight venture capital investment, he said.
The issue also came up at a September event where venture capitalists said the perception of a lengthening regulatory process in the U.S. was one reason why some VCs have exited the health care market.
The FDA released in August two draft reports with 55 recommendations for changing the 510(k) process used to quickly approve new systems that are similar to existing medical devices. The agency closed in October a public comment period on the report and is now evaluating the feedback prior to releasing a ruling.
The FDA proposals are available online. The agency also has a webinar archived online discussing the proposals.
Kleinhenz singled out six of the recommendations as particularly troublesome, mainly because they could be interpreted in ways that could be harmful or onerous for device makers. They include a proposal to create a new Class IIb category of devices similar to that used by European regulators.
The new class "is so broad we could drive a truck through it," said Kleinhenz. "We are pushing back very hard asking the FDA to specify exactly which categories will be Class IIb," he said.
In September, the AdvaMed trade group also came out against the proposal.
Kleinhenz said a proposed requirement to provide all relevant scientific data in an application also was too broad. In addition, a stipulation for annual reporting of changes with any 510(k) devices would be onerous for large companies that might have dozens or hundreds of such products, he said.
Another recommendation called for giving the FDA the right to revoke a 510(k) approval. That could have unintended affects for devices with approvals tied to any revoked products, said Kleinhenz.
In town hall meetings and presentations, FDA officials have tried to reassure industry it wants to balance its goals of ensuring safe and effective devices while fostering innovation. The agency suggested new rules would be phased in over time and allow, in at least some cases, for additional public comment.
Kleinhenz suggested the changes stemmed from an October 2008 letter to Congress from eight FDA reviewers alleging FDA management unfairly overturned their decisions. Congress quickly responded with a letter to the head of the agency pointing to "well documented allegations senior managers intimidated or coerced FDA experts to change scientific reviews."
"FDA has really stepped up and become more aggressive with industry" since that time, and the approvals process has become slower, he said.
He pointed to new enforcement policies and a rise of FDA warning letters to device makers in the last two years. The FDA sent out nearly 600 warning letters in 2009 up from about 400 in 2007, he said, although that is still well below historic highs of 800 to 1,400 warnings a year in the period from 1998 to 2001.
In addition, the FDA now requires companies to respond to the warning letters in 15 days and conducts follow ups on the letters including inspections in some cases. The agency has also waived a previous practice of having its legal department review all warning letters before they are sent.
"You will see much more hostility between the FDA and industry and vice versa, and you will see more companies taking the FDA to court," he said.
Kleinhenz's company is one of many that have gotten regulatory approvals and fielded products in Europe due to a longer more complex approval process in the U.S. "People go to Europe first because their process is more pragmatic and practical," he said.
FDA warning letters are on the rise since 2007.