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Establishing Current Good Manufacturing Practices (CGMPs) ensures that medical device manufacturers can better comply with regulations and standards like FDA 21 CFR part 820.100 and ISO 13485, including quality systems that identify, analyze, and correct quality issues. These corrective and preventive action (CAPA) processes are a major component of delivering and supporting medical devices in...
Introduction There are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application. Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that the device is safe and...
Introduction Maintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483...