In addition to above replies, consider the following points in your Due diligence
What is the premarket review/approval requirement for the device, and has it been met?
Premarket notification (510(k)) exempt.
Premarket notification (510(k)) –obtain copy of letter showing the device has been deemed “substantially equivalent”
Premarket Approval (PMA)
Does the foreign manufacturer, and initial importer or distributor have a current establishment registration? You can be verified from FDA website:
Establishment Registration & Device Listing
To what extent is compliance with FDA’s Quality system regulations (QSRs)/Good Manufacturing practices (GMP) required?
GMP Exempt (record keeping and complaint file requirements still apply)
Medical Device Reporting
Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA.
Mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices.
US Agent
Foreign manufacturers must also designate a U.S. Agent. The information on U.S. Agents can be found at:
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053196.htm
Compliance History of Manufacturer
What is the compliance history of the manufacturer, importer, and device?
Warning Letters
Recalls (Enforcement Report)
Is/has the device (been) subject to any of the following?
Import Alerts – used to initiate automatic used to detentions of regulated products
Import Refusal Reports – view by country or product
Establishment Inspection Reports (EIRs), EIRs are prepared by the FDA Investigator performing the inspection after every inspection. This Report details the inspection and findings, and includes exhibits to document findings.