Medical Devices

A medical device regulatory expert raised concerns that companies may see no benefit from participating in FDA’s newly announced plan to test its software precertification program, and, given the added burdens of doing so, there might not be enough volunteers to properly test the program.

The Senate Finance Committee has established group tasked with examining the Affordable Care Act’s 2.3% excise tax on medical devices, which will kick back in Dec. 31, unless repealed or again delayed, among other health-related taxes.

Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests.

FDA will take a range of actions to increase the agency’s uptake of breast implant adverse event reports and registry data, and will also make sure patients and providers are aware of the potential risks of such products by publicizing adverse events that were in a hidden database.

CMS Administrator Seema Verma on Thursday (April 2) announced the agency is changing the process for issuing Healthcare Common Procedure Coding System codes to give drug and device makers more opportunities to apply for them, and directed contractors to follow the Local Coverage Determination process for every decision rather than opt to automatically not cover technologies with temporary codes for emerging technology.

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23).

In the wake of a 35-day partial government shutdown that furloughed 41 percent of the agency’s staff earlier this year, a group of FDA policy experts sent a letter to the agency asking for more details on how much funding FDA had and from what sources; exactly how many personnel were exempted, excepted and furloughed throughout the shutdown; and how FDA is preparing for future shutdowns.