Gov’t Shutdown Delays Device Applications and More

New medical device and drug applications will be delayed at least a bit.

Medical device manufacturers which paid their user fees before December 22, 2018 will see progress on their pre-market notification and pre-market approval requests, the Food and Drug Administration (FDA) says in a statement at its website about the effects of the federal budget stalemate, which has left FDA without fiscal year 2019 government funding.

About 45% of FDA’s 2018 budget of $5.4 billion was funded by user fees. Activity funded by user fees already collected may continue during the lapse in funding since December 22.

However, for Section 510(k) notification applications and Section 513 applications for pre-market approval or any other user-fee-based regulatory actions which were not submitted by December 22, there will be at least a short delay in getting to market:

“… during the lapse period, the FDA will not have legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted,” FDA says at its website. “This will mean that the FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.”

Vital public-health activities and some other FDA-related activities are continuing. Development of the National Evaluation System for Health Technology (NEST), which is intended to be a faster, more real-world post-market adverse event reporting system for medical devices, is continuing, run by an independent governing body, the NEST Coordinating Council (NESTcc), which FDA funded for at least part of 2019 with 2018 money. FYI, NESTcc is seeking a project manager with project management experience in health care or medical devices.

5-Year Medical Device Tax Moratorium Fails … So Far

Federal legislation which would have extended the moratorium on the 2.5% medical device tax passed the U.S. House of Representatives on December 20. However, it was not voted on in the Senate while senators debated President Trump’s proposed wall funding. The bill would have needed 60 Senate votes to be considered, so it was deemed unlikely to pass.

The device tax moratorium was part of an annual bill known as the “tax extensions,” which starts in the House Ways and Means Committee each year and is usually passed, extending what are mostly personal income tax deductions and deferrals.

A new extensions bill will probably be reported by Ways and Means in the new Congress. The last tax extensions bill, for example, didn’t pass until February of this year.

However, the shift in the House majority to Democratic control makes a five-year tax moratorium on the device industry less likely to be approved by the House. A one-year or five-year moratorium on the medical device tax could conceivably be passed by the Senate in 2019 and then slipped into a final compromise bill, but that’s up to the new Congress.

Job-Seeking? NIAMS Seeks Clinical Director – Orthopedist or…

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