"FDA will not necessarily implement each of these ideas."

But the FDA wants the public to decide what areas to focus on, for now; once those are decided, the agency could tackle the resource and legal challenges, the FDA said.


"We recognize there are legal issues," Sharfestein said, "but we didn't want to be sidetracked into a legal discussion."

When asked by DOTmed News what proposals were most likely to get squashed, the FDA said the task force has neither characterized them that way nor have they prioritized them yet.

"We are asking for public feedback on what FDA's top priorities should be," Asamoah said in prepared remarks.

Advanced Medical Technology Association, a medical device industry lobby, reacted cautiously to the FDA's announcement. While saying they support the FDA's moves towards increased transparency, they hope the FDA's proposal to reveal facts about medical devices under investigation could be done in a way that doesn't leak proprietary information.

"The world-leading U.S. medical technology industry is highly competitive and disclosing the existence or other key details of a...marketing application could publicly reveal important intellectual property and other information which could put companies at a disadvantage without any countervailing public safety benefit," Janet Trunzo, executive vice president for technology and regulatory affairs for AdvaMed, said in a statement.

"Weakening intellectual property protections is a dangerous recipe for stifling investment in breakthrough products and could significantly impede medical progress and ultimately impair public health."

The agency seeks public comments for 60 days on the proposals, which will be published Friday in the Federal Register.

The proposals represent the second phase of the FDA's Transparency Initiative. The next phase covers transparency of decisions related to regulated industries, such as drug and medical device companies. Draft proposals from that phase should come later this summer, the FDA said.

The FDA's current transparency program dates back to June 2009, and was launched by incoming FDA Commissioner Margaret Hamburg in response to President Obama's call in January 2009 for "unprecedented levels of openness in government," the FDA said.


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