Devices & Diagnostics Letter

An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices.

Internal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in comments on a proposed rule on the tax.

The Centers for Medicare & Medicaid Services (CMS) is sparing devicemakers and group purchasing organizations from reporting payments made to doctors and hospitals in 2012, as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations.

Touted for saving Medicare millions, a federal competitive bidding program for durable medical equipment (DME) may be limiting beneficiary access to some devices as supplier numbers plunge.

Manufacturers hoping the FDA might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report.

CINCINNATI — Devicemakers wishing to establish a full online presence must take special care to ensure their use of social media doesn’t throw them out of compliance with FDA promotional speech regulations, Edward Basile, with the consulting firm King & Spalding, told a recent session of the FDA/Xavier University MedCon conference here.

The European Commission is preparing guidance to assist notified bodies during inspections of facilities where CE-marked medical devices are made.

China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.

CINCINNATI — Between corporate focus on profits and regulatory overreaching, healthcare in America is failing on every level, a device industry leader told attendees at the FDA/Xavier University MedCon conference here.

Makers of X-ray imaging devices would need to take special steps to ensure their products perform safely and effectively when used on children, under an FDA draft guidance issued Thursday.