The FDA's compliance standards require pre-market approval for most medical devices.
Most medical devices marketed in the United States need to meet a set of the U.S. Food and Drug Administration's compliance standards before companies can legally sell their products. The FDA also has compliance rules for companies after the medical devices go to market. The administration groups medical devices into three categories depending on their potential risks or uses: Class I, II or III.
Registration
Before companies that are proposing to handle medical devices do so, they need to register with the FDA. The businesses need to list with the agency any of the regulated products and explain their intended uses.
510(k) Forms
Section 510(k) of the Federal Food, Drug and Cosmetic Act states that companies can bypass the FDA pre-market approval process if the agency approves their 510(k) forms. In order to receive approval, companies need to show their products are safe and effective and they are similar to other already marketed devices.
Pre-Market Approval
Medical devices that could pose serious risks, are used for life support, or could be "of substantial importance" for medical care fall into the FDA's Class III device category. This means the devices need the administration's pre-market approval. Companies need to provide extensive proof that their devices are safe and effective.
Pre-Approval Exemption
Medical devices needing FDA Pre-Market Approval can be legally used by companies before receiving approval if they use the products for testing purposes. Any test subjects must be made aware beforehand that the devices are in a trial process.
Quality Checks
Once a medical device receives the FDA's approval, companies need to set up quality assurance systems for the devices. The FDA relies on companies to set up their own systems with little direct guidance from the government.
Failure Reports
If a medical device malfunctions or causes problems, injury, illness or death, the company must report it to the FDA. The administration has timelines set for how long companies have to file a report depending on the type of problem. The longest a company has is 30 days.
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