Just north of downtown Washington, DC, in suburban Maryland, lies the sprawling campus of the Food and Drug Administration (FDA), an agency that has a long history of safeguarding the health and wellbeing of Americans. For any medical device company seeking to sell its products in the USA, securing regulatory approval from the FDA is the sine qua non. Last year saw a record number of medical product approvals by the FDA, but the political deadlock just prior to Christmas is starting to have an impact. More than 40% of the FDA’s 17,397 employees have been furloughed – told to stay home without pay – during the shutdown.
Scott Gottlieb, commissioner of the FDA (seen above right, © FDA), has taken to social media to explain the implications of the government shutdown. Just a week ago, Gottlieb tweeted: “Many asked if #FDA can accept new product applications. The #FDA can’t collect FY2019 user fee payments during the shutdown, which means we can’t accept new applications for products under our user fee programs.” However, he confirmed that investigational new drugs and devices relating to the safety of individuals who are participating in clinical trials will continue to be reviewed during the shutdown.
For medical device companies, FDA approval can be achieved using either pre-market approval (PMA), a process that normally requires extensive – and costly – clinical trials, or the 510(k) approach, where a new product needs to demonstrate equivalence to an existing predicate device. This latter approach was used by Shanghai-based United Imaging Healthcare (UIH) to launch its products in the USA. This time last year, UIH had no products with FDA approval, but at the RSNA meeting in Chicago in November 2018, they had an impressive 14. Their portfolio included multi-slice computer tomography (CT), magnetic resonance imaging (MRI), and a dual-modality system combining CT and positron-emitting tomography (PET).
On 14 December 2018 the FDA published draft guidelines for the manufacture of diagnostic X-ray equipment, a replacement for regulatory policies promulgated thirty years ago. They stated: “Manufacturers should be aware that we intend to amend FDA’s performance standards to harmonize many requirements with those of the International Electrotechnical Commission (IEC) standards because FDA acknowledges the importance of simplifying compliance for global manufacturers.” This is good news for international companies like UIH and CapeRay.
It seems unthinkable that the building of a wall on the Mexican border could prevent Americans from accessing life-saving medical products. Let us hope that common sense will soon prevail so that the FDA’s employees can return to their important work.