Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and logistical supply web about serious regulatory and importation issues impacting the medical device industry.
Greater Scrutiny from U.S. Agencies
Importing medical devices and their components has already become more challenging, especially for medical device imports from countries of interest to the federal government. In particular, importers of international shipments of high value goods have received more Customs and FDA Requests for Information, import delays and holds, inspections and examinations. We expect increased scrutiny to expand to additional countries in the coming years as the Trump Trade Agenda begins to work itself out through the enforcement agencies.
Documentation Becomes Critical
Because of CBPs’ new ACE system,1 it is going to be easier for the government agencies to examine Customs entry data across federal agencies. When FDA or CBP catches errors in documentation, problems quickly escalate to held shipments, seized products, penalty cases, or import alert red listings. Whether your medical device importation is of a refurbished device, a device component, or a finished good, it is becoming harder to correct simple errors without incurring costly delays and increased rates of examinations. This applies to products that are entering U.S. commerce or are just in-transit to another country.
How We Can Help
FDAImports.com is more than a registration and listing service (although we do that too2). Our former FDA officials and affiliated FDA and Customs attorneys understand the regulatory burdens being laid upon the device industry. We regularly engage U.S. governmental agencies on behalf of our medical device clients who may have issues with FDA, USDA or Customs, including delayed shipments at the border. Companies also rely on us for device classification, 510(k) filings, product labeling and listing, facility registration, QSR compliance, HTS classification, required FDA and Customs documentation and USDA permits.
Contact us today with your device questions.
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[1] For more information regarding ACE and the single Window see: Customs Sets Effective Date of ACE for Various Remaining Transactions
[2] For more regarding FDAs Registration and listing season see: FDA Registration Renewal Season Opens October 1
