Medical Devices

The U.S. Supreme Court Monday (May 21) declined to take up a case brought by a coalition of drug makers challenging consumers' standing to sue over money lost due to a product design that allegedly wastes a portion of that product.

Some stakeholders are questioning the usefulness of the unified agenda in mapping out what regulatory actions FDA plans to take in the next 12 months, despite the White House’s claims that it has taken steps to make the semi-annual regulatory plan more useful to stakeholders.

CMS on Wednesday (May 9) released an interim final rule that will increase pay for durable medical equipment provided in rural and other areas not covered by the competitive bidding program from June through the end of the year, and the agency says more rules are planned on rates for DME and enteral nutrition in 2019 and beyond.

An industry attorney leveled a lengthy critique of FDA’s newly created Medical Device Safety Action Plan, calling different steps of the plan “extremely imperialistic,” “expansionist” and outside of FDA’s statutory authority as a regulatory agency.

Leading medical device industry groups suggested during a closed-door meeting on Capitol Hill this week that the industry's future depends on Congress overhauling CMS' coverage process to ensure breakthrough devices approved by FDA also are promptly reimbursed as additional data are collected.

FDA announced Tuesday (April 17) a five-pronged medical device safety plan that proposes sweeping changes to the way the device center functions, including reorganizing the center to be one large office made up of seven smaller offices that follow individual devices through their lifecycle.

FDA released two final and one draft guidance Thursday (April 12) aimed at streamlining the process by which in-vitro diagnostic manufacturers can come to market, and the newly unveiled policies may allow certain Next Generation Sequencing tests to be down classified from Class III and be exempted from premarket review.

FDA announced Monday (April 9) it is restricting the sale and distribution of Essure, a permanent contraceptive device, by limiting the device to prescription use and requiring labeling that specifies the training or experience practitioners must have to prescribe and implant the product.

The medical device industry is excited about what one representative from a top company recently called a culture change at FDA, which has been buoyed by what one lawyer called a flurry of legislation affecting the space.