An FDA proposal to increase its oversight of 510(k) medical device modifications has received pushback from AdvaMed, which warned the new rules could lead to a greater number of 510(k) submissions without doing much to benefit patient safety. The current process has proven to be successful in maintaining timely review and patient safety, and "it is unclear that there is a real problem that needs to be solved," AdvaMed said in a white paper. The FDA is scheduled to hold a public meeting today to discuss possible changes.
AdvaMed cautions FDA against unnecessary changes to 510(k) process
SmartBrief Job Listings for Health Care
Attest Health Care Advisors
|Biotechnology/Pharmaceutical Patent Attorney||
Coats and Bennett PLLC
|Sr. Regulatory Specialist, Biotech Center of Expertise||
BASF, The Chemical Co.
|San Diego, CA|
Meridian Health Plan