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Originally Posted by HermesRider
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Originally Posted by jphughan
Cool news, but I'm pretty sure it wasn't the FDA that had to approve this. Not all lasers (or even medical devices) get FDA approval. You sure it wasn't just DOT or NHTSA?
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They are class IV lasers; the FDA is certainly involved. Though the lasers only pump the phosphor that then emits the outgoing light, there is radiation produced, and potential for laser light to leak, and the FDA guards our safety through ensuring manufacturer compliance with Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, as well as Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040, amongst various other federal statutes.
With growing pressures to fast track approvals, the FDA seems to have changed its operational philosophy from preemptively warranting public safety to serving as more of a post-consumer database about products recalled after harm is reported (e.g. openFDA project), as evidenced by the incredible surge of recalls in 2014 alone. (BTW I'm not debating which philosophy is better, given the pace of change.) My sense is BMW elected for a protracted review (it's still up to BMW to get it right, not the FDA) and delay to US market rather than risk a senseless (expensive) recall on US soil, and ensuing negative press. |
Wow, very cool info! I stand corrected.
