The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. Not knowing when an FDA inspection will come can add to the stress.
For medical device startups, an FDA audit might occur five years from the time a design history file (DHF) was created. For established medical device firms with products on the market, an inspection might occur every two years. For manufacturers of Class II or Class III devices, whose products have received adverse-events complaints, inspections might come sooner. The higher the product risk, the more often an FDA audit is likely to occur.
The best way to get through an FDA inspection is to always be prepared for one.
Preparation includes the person responsible for the design control process understanding what to expect. The Quality System Inspection Technique (QSIT) Manual can offer some guidance.
The QSIT Manual describes the protocols used by FDA field staff inspecting medical device companies’ quality management systems (QMS). The manual identifies four major subsystems:
An FDA inspector will review each of these and three other subsystems – documents, records and change controls; facilities and equipment controls; and material controls – for compliance.
The QSIT Manual‘s design controls section, under which the DHF appears, identifies 15 steps for the verification of compliance with design control requirements in 21 CFR 820. When a company conducts an internal audit, the auditor assigned to design controls should consider the steps identified.
For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the DHF, which serves as a complete record of the design and development of a device. According to the FDA, "the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."
Put simply, the DHF serves as the repository of documentation generated by the design control process, with each of the elements discussed below contributing documents to the DHF.
When the FDA performs an inspection of the design control process, the inspector will select a DHF to sample. Not knowing which DHF will be inspected means it is crucial to always have all DHFs ready for inspection.
Because the DHF is the collection of this documentation showing the evolution of the design, it must be assembled and updated properly because it will be referenced throughout the life of the product. When maintaining a DHF, medical device companies must assess it for changes even beyond the development phase to ensure it accurately represents the product being delivered.
A paper-based DHF requires extra effort and vigilance in audit preparation. When an inspector shows up, they have to comb through piles of unstructured, disorganized documents that often lack traceability of what’s in the DHF. If it’s hard to follow for the company, the inspector will have a hard time finding information, too.
An electronic system makes it easier for medical device companies to maintain a constant state of audit-readiness because it simplifies DHF management and compliance. A paperless system enables companies to be a step ahead of any audit because all critical DHF documentation can be created, tracked and updated easily, with a central DHF index, and can be quickly found in a single system (with controlled access and editing rights), meaning the DHF will be available to the auditor immediately.
With proper preparation and a robust electronic system, FDA audits don’t have to be intimidating.
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