In my law and consulting practices, I focus on government regulation of the medical devices and combination products, including FDA and Medicare. Within that space, I further focus on:
1. Regulation of health information technology, including mhealth
--Regulatory assessments and 513g
--Submission strategy
--Quality systems
2. Medical device advertising and promotion, including
--Health economic claims
--Social media
--Scientific exchange an unsolicited requests
--ASR's and RUO鈥檚
3. FDA regulatory compliance
--Assessing need for recalls
--FDA defense
--Compliance remediation
--Internal investigations
4. Combination products, and particularly drug delivery and personalized medic...
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