As you know, medical device reporting procedures can be confusing. The laws are always changing, and your life science company needs to keep up with these changes to ensure compliance during every phase of product development.
That being the case, you need to familiarize yourself with FDA and international regulations. As an industry-leading eQMS provider, we're here to help you get up to speed.
Let's look at the four FDA medical device reporting procedures life science companies need to follow to ensure compliance.
4 FDA Medical Device Reporting Procedures for Compliant Life Science Organizations
What's at stake if your organization gets compliance wrong?
Unfortunately, medical device manufacturers are fined thousands of dollars annually for non-compliance. In addition to dollars and cents, this costs businesses valuable time and energy and can cause serious delays when trying to take new products to market.
And depending on the type of organization, you may be required to follow different rules and regulations. For example, under 21 CFR Part 803, you are required to report specific problems or adverse events caused by your device.
Here are the five medical device reporting procedures that your life science company needs to follow to stay compliant during every phase of product development.
1. Manufacturers and Importers
Have you experienced any malfunctions in your device that would be likely to cause serious injuries or fatalities? Do you believe that your device may have been responsible for the injury or death of a patient?
In either of these situations, you are required to fill out form 3500A and submit it to the FDA. You can find out more information about the specifics of what needs to be reported by reading 21 CFR 803.3.
Importers, on the other hand, are only required to report problems with devices to the manufacturer. It’s the manufacturer’s responsibility to make sure that any issues get reported to the FDA.
2. User Facilities Procedures
Is your organization a hospital, nursing home, ambulatory surgical facility, or outpatient treatment/diagnostic facility? User facilities are any facility that is not a regular physician’s office that uses your medical device to treat or diagnose their patients.
These types of facilities are required to submit annual reports to the FDA by January 1 each year. Just like manufacturers, these facilities are required to report any suspected fatalities or serious injuries caused by their devices.
3. Complaint Files Procedures
Complaints can come in the form of electronic, written, or verbal communication that claims your device is defective, unreliable, or unsafe. All complaints must be linked to the MDR event file because they need to be evaluated to determine if there is any truth to the claims.
Manufacturers and importers are both required to keep records of all complaints, and they must establish processes for handling those complaints from start to finish. These processes must include steps for receiving, reviewing, and evaluating all complaints they receive.
Related Reading: How Long Does the FDA Medical Device Approval Process Take?
4. eMDR (Electronic Medical Device Reporting) Procedures
Reporting can be completed electronically to ensure nothing falls through the cracks and to help speed up the process. The FDA has a free application called the FDA eSubmitter that you can use to submit MDR reports one at a time.
You can learn more about the FDA eSubmitter and how to download it here: FDA.gov: Electronic Medical Device Reporting (eMDR).
When you need to submit more than one MDR at a time, you can use the Health Level 7 (HL7) Individual Case Safety Report instead. Find out more about what it is and how it works here: Health Level Seven (HL7) Individual Case Study Report. Very simply, it allows you to submit your MDR files as a batch or individually—depending on your needs. Using this option means that you will send your MDRs as an HL7 ICSR message.
Beat the Competition with Better Quality
Are you ready to gain competitive advantage by improving the quality of your medical devices and your quality management processes?
At Qualio, we understand just how important it is for you to have the most efficient quality management processes possible when producing top-quality medical devices is your number one priority.
That’s why our experts created a custom eQMS software built with the unique needs of life sciences companies in mind.
“Coming from a manual, paper-based system, it’s amazing how it all just works. Qualio has forever changed how we manage quality.” — Tara Fitzpatrick, Quality Manager of Rowa Pharmaceuticals
“Qualio simplifies the approach to effective quality management. The web-based software is intuitive, which greatly reduces the amount of time required for users to come up to speed with the new platform.” — Dr. Christopher Devine, President and CEO of Devine Guidance International
“My favorite thing about Qualio is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.” — Deb Glancy, Director of Quality for Dimension Therapeutics (ULTRAGENYX)
Implementing an eQMS will make it a breeze to document every step of the process during the development, manufacturing, and distribution of your medical devices.
When you download our free guide, you’ll learn about what you can do to improve your quality management processes. We'll show you how to identify where you aren't meeting quality standards and how to ensure all your paperwork is in order so you can maintain compliance with federal and international regulations.
Download the free guide now to discover our secrets to success: 7 Ways to Improve Medical Device Quality.