Devicemakers Want More Clarity on Third-Party Audit Program

Devicemakers want more clarity on third-party audits by regulatory agencies in other countries, especially when it comes to possible enforcement actions. In one of 28 comments on the FDA’s draft guidance on the program, Cardinal Health asks whether the FDA could take enforcement action against a company as a result of such an audit. The final guidance needs to address the FDA’s authority over a manufacturer’s responses to the third-party auditing agency, Cardinal Health says, as well as the steps the FDA would take if it does not agree with the company’s response and proposed corrective actions.
Devices & Diagnostics Letter