US FDA Simplifies Variance Application Process For X-Ray Companies
X-ray manufacturers and importers submitting Electronic Product Control reports will only need to submit their variance application package once.
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X-ray manufacturers and importers aren't required to submit Electronic Product Control (EPRC) reports if their product already conforms to certain IEC standards in their 510(k) notifications, the agency's 7 May guidance says. The goal is to reduce the workload for device-makers and regulators alike.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
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