Medical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in judgments and settlements collected in the fiscal year 2016.
The Food, Drug, and Cosmetic (FD&C) Act gave the FDA authority to conduct inspections at medical device manufacturing facilities. On a practical level, in general, the FDA’s inspection selection process is primarily driven based on risk. Those companies manufacturing higher risk devices, top the list. Thus, manufacturers of class III devices, newly registered facilities, implantable, life-supporting, and life-sustaining devices, are the primary subjects for inspection.
FDA uses the Quality System Inspection Technique (QSIT) for its inspections, a ‘top-down approach’ to inspecting a manufacturer’s QS. QSIT provides different inspectional levels based on the reason for the inspection. In the medical devices industry, QSIT is used by the FDA to assess the firm’s QS for compliance with the appropriate regulations and for inspection of domestic and foreign manufacturers of medical devices with the intention commercial distribution within the US.
Medical device companies will most likely face three types of inspections by FDA: a pre-approval inspection, a routine inspection, and a compliance follow-up inspection. The intention is to ensure and protect the public from unsafe products. The three are:
FDA Pre-Approval Inspections
Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection. A recommendation for approval is determined by inspectors following a site visit.
By law, routine inspections take place every 2 years for class II and class III device manufacturers. Method of inspection follows the guidelines as outlined in the Quality System Inspection Technique (QSIT). Any violations or problems found during a routine inspection, the company would be subject to fines, or quite possibly temporary shutdown of production.
The Follow-Up Inspection
Compliance follow-up inspections are a response to warning letters or significant FDA Form 483 inspectional observations to verify that corrective measures have been taken by the manufacturer as a result of previous inspection violations. A compliance follow-up is conducted to document the correction of violation(s), or note continuing violations, or to take regulatory action.
Medical manufacturing companies can successfully and seamlessly bring compliant medical devices to market by following certain basic steps. Start by implementing a robust regulatory compliance program in-house. Prepare for FDA inspections. Your quality control program must help ensure, monitor and strengthen compliance across your company’s operations. Follow-up on previous inspections and document any corrective actions taken. Data is evidence, so maintain all records and documents. The key is to ensure compliance through documentation. Implement an effective, timely CAPA (Corrective and Preventive Actions) system to identify and address any violations immediately. Finally, make sure your company’s employees have a thorough awareness of FDA inspections and their compliance. You may even perform mock audits occasionally to prepare for inspections.
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It’s the medical manufacturer’s responsibility to keep abreast of the current FDA regulations as pertains to your company. Stay tuned in by attending conferences or webinars, review professional publications, and whenever there may be a question on compliance, ask for a ruling directly from the FDA.
Being subjected to government actions will consume time and resources for your company. Statutory and regulatory violations can result in injunctions, significant fines, unwanted publicity, even criminal penalties, or consumer and shareholder lawsuits. In this regard, the goal for all medical manufacturers is to maintain FDA awareness and make sure your company stays compliant.