Common Medical Device Regulatory Compliance Roadblocks

Author: Christine Scheve | Date: October 22, 2021

medical device regulation complianceThe medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and follow quality systems that ensure products consistently meet applicable requirements and specifications, the FDA offers little guidance to the medical device industry as to how. This leads to confusion and, ultimately, non-compliance for many. Today, we will examine the most common FDA medical device f regulatory compliance pitfalls that companies encounter—so you know what to avoid as you bring your next product to market in the US.

Four medical device regulatory compliance pitfalls—and how to avoid them:

1.      CAPA violations: Corrective and Preventative Actions (CAPA) procedures and systems aredesigned to collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. While CAPA’s are not optional,many companies are being cited for CAPA violations—typically for inadequately establishing CAPA procedures or failing to document them. Don’t wing it when it comes to CAPA. Establish your procedures early as part of an overall Quality Management System—and make it front and center. When conducting a CAPA investigation, be thorough so that you can get at the root cause of a problem.

2.      Inadequate complaint procedures: As outlined in the FDA’s Code of Federal Regulations Title 21, medical device manufacturers are required to follow a specific procedure for customer complaints. Any complaint that alleges fault with your device, whether written or verbal, must be clearly documented and addressed. Without an adequate complaint-handling system, you not only run the risk of non-compliance but also open your company up to recalls and product seizures. To avoid this, establish and implement complaint procedures that define how you will receive, evaluate and address complaints.

3.      Poor document management and control: ISO, ISO 13485, and 21 CFR Part 820 9001 contains specific requirements around the control of your documents to prove conformity and demonstrate the effective operation of your quality management system. However, they don’ttell you which documents require those controls, how they should be formatted and labeled or how many approvals are needed. As a result, many medical device manufacturers find themselves unexpectedly failing an audit. Consider using a browser-based software program, like Polarion, to easily track and manage your documentation throughout the lifecycle of the project.

4.     Medical device reporting: Manufacturers are required to report any medical device incidents that cause serious injury or death—or a malfunction that could lead to serious injury or death. Those who fail to create and follow written medical device reporting procedures are in violation of 21 CFR 803.17.  Keep in mind, omitting certain terms defined in 803.17, or even key descriptions, may also render you non-compliant. Beyond establishing formalized written procedures and plans per the FDA requirements, be sure to abide by and frequently review them to ensure they continue to meet the code.

With so much to keep track of when it comes to FDA medical device regulation compliance, it’s no wonder so many manufacturers find themselves in trouble. Ultimately, achieving and maintaining medical device regulatory compliance comes down to a commitment to quality. With quality as the guidepost, you can avoid most of these headaches, save money and get your product to market faster.

At Sterling Medical Devices, we offer regulatory compliance consulting to help you meet regulatory controls throughout the entire product development life cycle. To talk to someone today about your medical device regulatory compliance concerns or for more information about our FDA medical device regulatory compliance consulting services, contact us here

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