Medical Devices

FDA drug center chief Janet Woodcock warned her staff on Monday (Jan. 28) that progress on rules and guidances might be slower than usual as the agency recovers from a month-long partial government shutdown that left 41 percent of its staff furloughed.

FDA just took two steps toward realizing a controversial plan that would change parts of the 510(k) process: introducing objective performance criteria and encouraging medical device makers to use younger predicates in their applications.

FDA Commissioner Scott Gottlieb took to twitter on Friday (Jan. 11) to assure stakeholders that, despite the three-week-old partial government shutdown, FDA is “continuing to prioritize our device safety work both before AND after medical devices come to market.”

CMS says in recently released guidance that states do not need to obtain a Medicare denial for certain durable medical equipment coverage before Medicaid, which acts as a secondary payer for those dually eligible for Medicare and Medicaid, can pay for the equipment.

Medical device experts say that crafting new regulatory frameworks for laboratory developed tests (LDTs), digital health apps and medical device cybersecurity are among the top FDA-related issues they will be tracking in 2019.

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

HHS and the healthcare industry issued cybersecurity “best practices” that focus on baseline measures such as protecting emails, limiting system access and developing incident response plans -- based on a pre-testing process intended to assess the effectiveness of the security guidelines.

The American Association for Homecare says that durable medical equipment suppliers that want to re-enter former competitively bid markets may be interested in becoming non-participating Medicare suppliers so that they can charge beneficiaries more than the Medicare allowed amount, given that CMS left many of the DME rates relatively low during the gap before the next round of competitive bidding starts.

FDA Commissioner Scott Gottlieb reaffirmed his agency’s pledge to keep a close eye on a female sterility device that has attracted international scrutiny this year for causing serious pain and bleeding in many women implanted with the device.