News & Articles

Wayne Moore

6/14/2022

More often than not when someone in the medical device space mentions the FDA the common response is a big frown. In terms of popularity, they are too often viewed as the IRS of medical devices – infinite power and no accountability. In my 40+ years in the medical device space I have seen the FDA at its worst, and at its best. I have filed or been a contributor to more 510(k) submissions than I can remember. The FDA is a customer of Acertara for our ultrasound test devices. I have had the honor of visiting the FDA campus many times for q-Sub meetings, technical, and regulatory meetings. Over the years I have met and spoken with three different heads of the Agency. I have also served on various technical committees with FDA scientists, such as the American Institute of Ultrasound in Medicine (AIUM) technical standards committee and the acoustic output power committee. During my career I have seen how many things were on the FDA’s plate at any given time and how they adroitly worked through and prioritized the issues using risk-based management techniques (yes, the FDA has finite resources). The most frequent description regarding the performance of the FDA that I hear is “they are too slow”. Too slow clearing or approving devices and drugs, too slow in issuing Guidance documents, too slow in answering questions, and too vague in their answers to those questions. Recently the FDA closed a baby food factory (Abbott) following a for-cause inspection. They have been, in my view, way too slow in resolving the issues with the company and getting this important business back on-line, resulting in an extreme shortage of baby food and some panic in the market. With what appears to have been a myopic focus on the for-cause inspection they failed to understand or appreciate how shutting down this facility would impact the supply chain of this product and cause the current crisis. The Agency and the Company could have been working 24×7 schedule to resolve the issues with the facility as quickly as possible to mitigate risks to public safety and impacts to the food supply chain. Instead, it appears that the Agency worked on this issue at a pace that they might have worked on with a non-critical supplier (i.e., slowly). The FDA is not known for its business acumen; that is not their strong suit. But they should have seen this coming. I like the FDA, I want to see them succeed and keep medical devices, pharmaceuticals, and food safe for the American public. This event was not their finest hour: I hope they learn and make necessary processes changes from it.

Until next month,

Wayne