Re: 510(k) Timing from Submittal to FDA Approval
I am looking at importing breathalyzers into the USA. I do know that these breathalyzers do not have current FDA 501(K) certification. Does anyone know how I can determine if I need to file a FDA 501(k) for breathalyzers?
Yes, you do. The ProCode is DJZ, Class I but 510(k) required, not GMP exempt.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5254
At least two companies have 510(k)s using the term "breathalyzer".
Does anyone know the actual costs for this and how to expedite it?
The fastest way to obtain a 510(k) is to hire a third party to develop and clear it. A list of approved third parties for DJZ is at the above link. The cost for such an approach will depend on many factors, including the status of your QS, design control and GMP compliance.
Is their punishment if I import and sell a device that does not have FDA 501(K) approval, yet requires it?
Maybe. The likelihood goes way up if the FDA detects an intent to not comply, such as is evidenced by the above statement.
Their response could range from a slap on the wrist, i.e. a Warning Letter and a requirement that you do all the skipped steps retroactively, to those steps plus an import hold until they're done...i.e. your subsequent shipments go into a Customs warehouse and you pay rent until they feel like releasing them...plus a required recall (you buy your products back from your customers, and maybe are required to scrap them; no sales until you prove you've gotten a high enough percentage of them back).
At the extreme end, in the event of intention to violate, they can padlock your US facilities, apply an administrative fine against the company, have the Department of Justice bring criminal actions against the owners and senior management, and/or confiscate and destroy your inventory and marketing materials.