The approval backlog is here, and the medical device industry is pleading with Congress to fund the FDA during the government shutdown, Medscape reports.
What you should know:
1. Although the FDA has around two to three months of funding through fees paid by medical companies, the agency has not been able to accept new user fee payments or new device applications since the shutdown began.
2. Medscape reports device manufacturers submit about 300 device-related applications to the FDA monthly. Of those applications, the majority (290) are for existing product modifications, five are for premarket approval and five are de novo applications.
3. AdvaMed President and CEO Scott Whitaker said he didn't have statistics for January, but he believes the application numbers, "are likely to be similar, which means that a backlog has already begun."
4. "The longer the shutdown goes on, the more and more the backlog will build up," Mr. Whitaker said.
5. Medical device lobbyists are asking Congress to pass legislation allowing the FDA to process new device applications and accept user fees. The lobbyists are also attempting to allow the FDA to tap into unearned user fees during funding lapses. These fees are paid by companies that never apply or register a facility. AdvaMed estimates the FDA has $7.5 million in unearned fees.