A Senate panel on Wednesday cleared a bill that would allow the FDA to evaluate the safety of approved medical devices and give conditional approvals dependent on further studies. The measure also would tighten the agency's 510(k) process that permits firms to prove the similarity of their devices to products already approved without needing extensive trials.
Bill seeking stronger FDA oversight of medical devices advances
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B. E. Smith
Attest Health Care Advisors
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Coats and Bennett PLLC
|Sr. Regulatory Specialist, Biotech Center of Expertise||
BASF, The Chemical Co.
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