The FDA Center for Devices & Radiological Health chief Jeffrey Shuren, MD, fielded questions related to medical devices, protecting patients and promoting innovation during a congressional hearing this week, according to a MassDevice report.
Republican members of the Senate Health, Education, Labor & Pensions committee — including Sen. Richard Burr and Sen. Orrin Hatch — questioned the FDA's failure in negotiating medical device user fees, the unpredictability and delays of the approval process and the agency's 510(k) process.
Dr. Shuren told congressional members the FDA's goals involve making device review processes more efficient and simpler but said some of the blame is on the industry for submitting applications of "poor quality." Unlike the drug review process, the FDA works with device companies to improve the application instead of just sending the application back to the manufacturer. This can slow the process down, Dr. Shuren said.
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Republican members of the Senate Health, Education, Labor & Pensions committee — including Sen. Richard Burr and Sen. Orrin Hatch — questioned the FDA's failure in negotiating medical device user fees, the unpredictability and delays of the approval process and the agency's 510(k) process.
Dr. Shuren told congressional members the FDA's goals involve making device review processes more efficient and simpler but said some of the blame is on the industry for submitting applications of "poor quality." Unlike the drug review process, the FDA works with device companies to improve the application instead of just sending the application back to the manufacturer. This can slow the process down, Dr. Shuren said.
Related Articles on the FDA:
Congress Plans to Increase FDA Budget to $2.5B
FDA Opens Comment Period on Device Reclassification Process
10 Recent FDA Drug and Medical Device Decisions