The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading virus. Companies in the medical diagnostic space should not be waiting for the EUAs to be issued to begin gathering the data for review by those qualified to evaluate and prepare EUA submissions.
In addition, there are many US companies capable of producing such diagnostic tools and medical products for export to other countries, which is also an FDA-regulated activity. Companies should use care to ensure that they meet the statutory requirements for exporting medical products that require approval for US marketing but lack that approval. Although this is permissible, it is strictly regulated.
As evidenced by the level of inquiries we received at the Florida International Medical Equipment (FIME) show in Miami, FL, importers and manufacturers of medical device test kits anxiously await a pathway from FDA. Without the EUA discretionary pathway, the only pathway to market is preparation and submission to FDA of a 510(k) (or Premarket Notification). Now that the Biden administration has declared monkeypox to be a public health emergency in the United States, a less burdensome pathway could be carved out via EUAs.
Our team of regulatory consultants and affiliated attorneys are available to help device manufacturers demonstrate the appropriate validation standards required by FDA for EUA tests. We regularly assist companies with 510(k) submissions, labeling and claims reviews, and facility registration and product listing. Please feel free to contact or call FDAImports for assistance at 410-220-2800.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
