There are many different criteria which medical manufacturing companies and medical instrument companies are required to meet for FDA approval. One of these areas is the inspection of medical device manufacturers. If you are in the medical instrumentation industry, how do you successfully and seamlessly bring compliant medical devices to market?
In a recent article in Med Device Online, Peter Ohanian from the Halloran Consulting Group, explains there are four different types of inspections for medical device manufacturers, what they are for, who and why you can expect to receive them. You can certainly expect a visit from the FDA and need to know that all inspections are not treated the same.
The Four Types of Inspections are:
- Pre-Approval Inspections are conducted when a company wishes to introduce a new product to market and submits an application. These inspections focus on verifying whether the product is compliant, and confirming that the facility is capable of manufacturing the new product.
- Routine Inspections are mandated by law every 2 years for class II and class III device manufacturers, following an FDA Quality System Inspection Technique (QSIT). The inspection classification may switch to a "for cause" inspection if a serious public health risk is identified.
- Compliance Follow-Up Inspections In response to a prior inspection that resulted in 483s or warning letters. Verifying that the adequate correction of previous violations, to document continuing violations, or to support future regulatory action.
- “For Cause” Inspections investigate a specific problem that has been reported to the FDA from a manufacturing recall, consumer complaints, or even a disgruntled employee. A “for cause” inspection focuses on the reported issue, and can also cover unrelated items of the facilities' operations.
Prepare for Your Inspection:
- You may or may not have advanced knowledge that the FDA will be inspecting your facility. Facilities with compliance usually receive notice of a routine inspection 5 days in advance. Companies with prior violations may not receive any notice and will have on-the-spot inspections. Follow-up inspections and “for cause” inspections are not pre-announced. Also, FDA inspections of a foreign establishment typically are scheduled two to three months in advance.
- Using a risk based approach and monitoring the Establishment Registration database , the FDA decides which facilities to inspect and looks into which medical devices they manufacture. Identifying the facility, the database then classifies each firm by risk: Class III > Class II > Class I. They are also classified by how high of a risk the device is; such as a life sustaining/supporting device. Another factor in who receives priority visits, is if the facility has recently brought a new device to commercial market.
- The FDA has developed QSIT to systematically assess the compliance of a facility. QSIT identifies the four major subsystems of the quality system: Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. QSIT evaluates and explains the purpose and importance of each subsystem, utilizing flowcharts and objectives for each subsystem.
With various types of inspections, it is a best practice to always be prepared and up to date with FDA regulations. At KMC Systems, quality is at the heart of every aspect of the business. Having a robust ISO 13485 environment ensures that Design Controls and Manufacturing Operations are compliant. KMC's FDA-compliant, automated software system has been customized over three decades to adhere to strict processes and complex applications which ensures greater adherence to regulatory requirements.
To learn more about KMC's standard of quality, read the Quality Assurance Blog, where KMC discusses 3 best practices of quality assurance in contract manufacturing, which are available for download in the tip sheet below.