Devices & Diagnostics Letter

BALTIMORE — Aware that issuance and closure of devicemaker warning letters are lagging, CDRH recently uncovered 60 “confusing factors” impeding its performance and efforts are underway to weed them out, center officials say.

Building on the enhanced tracking abilities that will be created by implementation of unique device identifiers (UDI), the FDA plans to begin rolling out by year’s end an enhanced postmarket surveillance program for medical devices.

Developers of medical device mobile apps don’t just need to worry about the FDA’s advertising and promotion regulations, they also must ensure any marketing claims comply with a new FTC guideline.

Registries that track a device through the entire product lifecycle could offer a wealth of information to stakeholders, but how they should be designed and administered remains problematic, experts say.

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a web page advertisement and other promotional materials for the product, according to an FDA untitled letter.

Industry still believes Congress will repeal the 2.3 percent medical device excise tax before its scheduled Jan. 1 implementation date, but if efforts fail, devicemakers face a “struggle” to ready in-house systems to begin paying the tax, Andrew Van Haute, associate general counsel at AdvaMed, told D&DL.

Hospitals could begin utilizing medical body area networks (MBAN) to wirelessly transmit data to and from medical devices early next year, one company predicts, following release of a Federal Communications Commission (FCC) final rule on MBANs.

CDRH has updated an internal document on resolving differences in regulatory and scientific opinion about the safety or efficacy of a device to better balance official administrative steps with protection of whistleblowers.

Despite launching in 2010, the FDA’s Medical Device Epidemiology Network (MDEpiNet) is still trying to determine which existing patient registries and surveillance systems to emulate to enhance device postmarket surveillance, stakeholders said at a Tuesday FDA public workshop.

The GOP-led House easily passed a continuing resolution supported by Democrats and President Barack Obama to keep the FDA and federal government open through March 27.

The FDA has warned BioMerieux for several violations related to rework procedures and corrective and preventive actions (CAPA) for its microbial detection systems.

Contact lens manufacturers should tie risk assessments to the shelf life of their products to ensure they don’t deteriorate during storage and are safe and effective when used, a revised International Organization for Standardization (ISO) standard advises.

The FDA has warned TCM Supply Corporation, a distributor of health lamps, for shortcomings in its supplier controls and good manufacturing practices.

Despite pressure from senators at a roundtable on implementation of the Physician Payments Sunshine Act, a representative from the Centers for Medicare & Medicaid Services (CMS) simply said the agency hopes the rule will be released soon and that manufacturers’ data collection will begin in 2013.