In a survey, the agency found total review times had expanded by more than 55 percent since 2005, but it cited the industry –– not flaws in its own approval process, as devicemakers have alleged –– for the decline. For example, the agency said it had to ask for second-round “Additional Information” letters for 65 percent of applications it studied because the original AI letter did not include enough requested information.
The FDA said 83 percent of applications it studied had problems in one of the following areas: inadequate device description, discrepancies throughout submission, problems with indications for use, failure to address current standards, and missing performance testing and required clinical data.
Read the report on delays in the FDA approval process.
Related Articles on the FDA Approval Process:
Devicemakers Ask Congress to Ease Regulatory Burdens on Industry
FDA Acknowledges Concerns Over Device Approval Time
Minnesota Lawmakers Blast FDA Medical Device Policy
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