FDA Compliance Protocols
As physicians, patient groups, and Congress pressure the FDA for stronger monitoring and recall action on devices and diagnostics, a manufacturer’s risk-management program must be stronger than ever. However, while the FDA recommends the ISO 14971 standard, other protocols may actually provide greater recall prevention for a company’s specific products and manufacturing processes. Just published by FDAnews, “Strengthening Risk-Management Practices: Concepts and Tools” teaches readers how to assess their best options and implement a program that keeps their products on the market and company off the FDA's high-risk inspections list. Information: www.fdanews.com.