Abbott, J&J tell FDA how to save the industry hundreds of millions of dollars

J&J wants the agency to award initial marketing approvals to certain devices after they secure European CE marking. (FDA)

Abbott and Johnson & Johnson have told the FDA which medical device regulations they think the agency should scrap or revise. The device makers and 22 other organizations proposed how the FDA can cut the regulatory burden by hundreds of millions of dollars and comply with President Trump’s anti-red tape executive orders.

Officials at the FDA asked for insights into how the agency can streamline its regulations late last year. Now, with the comment period closed, the FDA has published details of how companies and trade groups want it to repeal, replace and modify its regulations. 

The feedback spans multiple areas of device regulation and ranges from the broad to highly specific. Areas of convergence among some of the big players include opposition to the FDA’s proposed rule on the electronic submission of labelling for certain home-use medical devices. Abbott and medical device trade group AdvaMed were among the respondents to argue the proposal imposes burdens without realizing compensatory value.

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“Establishment of an FDA database to maintain device labeling creates a perpetual, onerous and government-funded costly regulatory requirement,” Abbott wrote in its response to the FDA. “Creation and submission of electronic labeling creates a perpetual, onerous and costly regulatory requirement for the industry, which will require the establishment and maintenance of IT systems to produce the SPL-formatted labelling.”
J&J’s response largely echoed submissions from the trade groups BIO, PhRMA and AdvaMed. But the company also included a bold reimagining of how and when the FDA approves life-saving class III medical devices. J&J wants the agency to award initial marketing approvals to such devices after they secure European CE marking. That would shift the burden of data generation from pre- to post-market and thereby cut the time it takes for certain devices to reach patients in the U.S. 

Other themes picked up by the respondents included the folly of applying unique device identifiers to combination products, the value of deleting paper copy provisions from 510(k) rules and the need to end the practice of updating labels when manufacturers change addresses.