Medical Device Recall Regulations
Medical Device Regulations
The FDA Code of Federal Regulations Title 21 outlines the requirements for medical device recalls. These regulations establish the actions that manufacturers, user facilities, or importers must take when a recall occurs.
While device destruction isn’t always the only course of action needed, good records (files) and reporting is always necessary to adhere to medical device recall regulations.
Code of Federal Regulations Title 21
The manufacturer is responsible for the removal and correction or destruction of a recalled medical device.
Read the FDA’s requirements for recalls, corrections, and removals of medical devices.
According to the FDA, to correct a medical device recall, one of the following actions must be met:
- Repair
- Modification
- Adjustment
- Relabeling
- Destruction
Download the FDA’s Regulatory Procedures Manual.
Recall Strategy Requirements
A recall strategy must include “the degree to which the product remains in the market-place” and “continued availability of the essential product”. IoMT Solutions specializes in the required medical device destruction and reporting that is required by the FDA. By building a recall strategy that includes full destruction and compliant recycling into a recall strategy, the end-of-life requirements will be met.
IoMT Solutions Reporting
Quality reporting is an important aspect in a recall strategy. IoMT Solutions reports lists every item we receive, including the client information, the container information, the container seal, the product description, serial number, quantity, and any other required information. We provide a certificate of recycling and destruction. As a certified electronics recycling facility, our reports will satisfy medical device recall regulations or final disposal strategy.
“The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal.”
Any Document | Any Time | Any Project
Our Compliance Library Makes it Easy to Retrieve Any Document at Any Time From any Project.
In 2010 we introduced our web based document archive “Compliance Library ™” and have steadily improved the accessibility and ease of use of this service. Therefore, now we provide all project documentation such as bills of lading, project quotes, project invoices and relevant project emails.
The Compliance Library™ identifies the location and date of the specific event. It is fully searchable and gives you the ability to find the disposal records of a single asset by simply typing in the barcode label. We make sure every device is accounted for, tracked, and all details are reported. It’s our commitment to providing 100% FDA compliant product destruction.