Due to growing concerns regarding cyber security risks, as well as other threats posed to the average US citizen in regards to medical healthcare devices and drugs, the FDA banned imports from Singapore’s Biosensors Int. after inspection dismissal. This makes the Asian company the 5th one to get banned due to the refusal of an FDA inspection, joining Intop Tech Co. from China, Shanghai Realov Electronic Technology Co., Sewa Medicals from India, and Morris Engineering Works from Taiwan.
At first glance, it may seem rather interesting how all of the banned companies are from Asia, but this is more than likely not linked to the companies’ homeland. The procedure through which a company is ordered to undergo a thorough inspection from the FDA before allowing the companies’ to import products to the US is started through a formal notification.
If the company fails to respond within 5 days since the notification has been received, the import ban is installed until further notice. The Biosensors International company from Singapore has stated that due to a technical difficulty it was unable to respond before reaching the deadline. But as that issue was resolved, the company welcomes the inspection from the FDA wholeheartedly.
The company in question has been importing to the US since 1992 and has been undergoing regular inspections and audits up to this point. Its main products are BioMatrix abluminal biodegradable polymer drug-eluting stents. According to their website, even if US imports are banned by the FDA, their products are still used in certain regions in the form of the aforementioned stents, bare metal stents, and angioplasty catheters.
The FDA has also recently released a guidance draft in order for pharmaceutical companies that manufacture connected medical devices to attain a higher degree of security towards cyber security threats. This draft was created with the help of the Research and Development team of the federally funded group known as Mitre.
This draft does not only point out the steps to take in the case of an immediate security threat in order to completely quell it. It also shows workarounds and temporary fixes which can be used in order to stall the progression of the threat throughout the system until a more direct approach can become feasible.
Although the FDA banned imports from Singapore’s Biosensors Int. after inspection dismissal, this ban will more or less be lifted after a full inspection is underwent at the firm. Nonetheless, the FDA has stated that companies which import medical products to the US should expect both scheduled and unscheduled inspections from now on, in order to eliminate any threat that may affect the average US citizen.