In order to go public in the USA with a medical device, developers must pass FDA medical device compliance audits / inspections. Equipment falls into one of three categories based upon the intended use of the equipment: Class I, Class II, or Class III.
A shortened definition of a medical device includes any instrument designed to affect the health or structure of a human body that does not achieve its goal by chemical action or by being metabolized. Class I medical devices pose very little risk to patients while Class III devices, which may have life-threating consequences, have the most risk and are subject to more stringent compliance regulations.
Understanding The CAPA System
An important part of staying compliant is following the corrective and preventative actions (CAPA) systems throughout the entire development process. Should problems arise with a component of a medical device system, or with the system as a whole, each component of the medical device deviating from its design is subject to a CAPA subsystem in which information is gathered and analyzed to report, document and mitigate the problems within that portion of the product and the quality of its manufacture in order to satisfy the design requirements of that medical device.
During an FDA medical device compliance inspection, the manufacturer must demonstrate that procedures are both in place and are being followed to identify and correct problems within the manufacturing process. CAPA requirements may be more challenging and stringent for Class III medical devices than those for Class I or Class II devices. Both statistical and non-statistical tests should be in place and must be properly documented.
How To Prepare For An FDA Inspection
Since FDA inspections are done to protect the health and welfare of the patients who will use the medical devices, most companies develop plans that will keep them in full compliance. However, because the inspections are so rigorous, preparation is necessary before the FDA inspection team arrives. Inspectors generally arrive within a couple of weeks of requesting a full inspection so preparation should be ongoing.
One person should be in charge of gathering the required materials and all staff and in particular the subject matter experts (SMEs) should be prepared to be interviewed by the inspector(s). If there was a process problem noted in a past inspection, documentation should be presented, whenever requested by the FDA, to show the process changes put into place since the last visit.
Because there are so many benefits of a mock audit, many medical manufacturers hire consultants to help prepare for their FDA inspections. When in-house efforts are aided by an outside consulting company, inspection results may show significant improvements.
Documentation Problems - Most Common During FDA Inspection
Documentation is key to successfully pass the FDA compliance inspection for medical devices. Major problems occur when either procedure is not fully written and securely stored or those procedures are not adequately followed. For example, if a quality test during a production run shows problems, the steps to remove faulty products from production must be clearly developed and available to personnel. This instance of quality failure must be documented as well as the actions taken by staff.
Staying up-to-date with FDA compliance rules when manufacturing medical devices makes sense. The more organized your program, the better your results will be for FDA approval.
GxP-CC is comprised of experienced compliance consultants who work with life sciences firms to assist them in meeting FDA and EU regulations and mandates. Contact them today to discuss how they can help you with the CAPA process.