Safety First – FDA Authorization of Medical Devices
“FDA approved!”
You may have seen those words on the web site of a company, or in a commercial advertisement of a new device or procedure. Several advertisers may say their products are “approved by the FDA,” but how do you know for sure what is licensed by the U.S. Food and Drug Administration?
The role of the Food and Drug Administration (FDA) is to protect public health. The laws imposed by the FDA on such products including new medicines and specific medical equipment must be verified safe and reliable. The healthcare industry must adhere to the requirements before they can introduce medical products into the market.
Medical Device Regulations in the USA
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for controlling companies that manufacture, repackage, relabel and/or import medical products that are sold in the United States.
Medical devices are categorized into Class I, II, and III. Regulatory control increases from Class I to Class III. The regulatory criteria for a general category of devices are specified by the device classification regulation.
Majority Class I devices are excluded from Premarket Notification 510(k); Most Class II devices demand Premarket Notification 510(k); and Premarket Approval is required for most Class III devices.
Types of FDA Regulations for Medical Devices
The fundamental health and safety regulations that manufacturers of medical devices distributed in the United States must fulfil are:
1. Establishment Registration - 21 CFR Part 807
Medical device producers (both domestic and foreign) as well as initial distributors (importers) have to register their organizations with the FDA. All applications for establishments must be submitted online, unless FDA has granted a waiver. All information about registration must be validated annually between 1 October and 31 December of each year.
Along with registration, international companies are required to appoint a U.S. Agent. Most establishments are expected to pay an establishment registration fee as of 1 October 2007.
2. Medical Device Listing - 21CFR Part 807
Manufacturers are expected to list their products with the FDA. Establishments required to list their devices include:
- manufacturers,
- contract manufacturers that commercially distribute the device,
- contract sterilizers that commercially distribute the device,
- repackagers and relabelers,
- specification developers,
- reprocessors single-use devices,
- remanufacturer
- manufacturers of accessories and components sold directly to the end user
- U.S. manufacturers of “export only” devices
3. Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
If your product mandates the submission of a Premarket Notification 510(k), you cannot sell the product commercially until you receive a letter of significant equivalence from FDA authorizing you to do so. A 510(k) must prove that the product is substantially equivalent to one lawfully in commercial operation in the United States: (1) before May 28, 1976; or (2) it is substantially equivalent to a product defined by FDA.
– 510(k) Review Fees
Medical Device User Fee and Modernization Act of 2002 became law on October 26, 2002. It authorizes the FDA to charge a fee for Premarket Notification 510(k) reviews of medical devices. A small business may have a reduced charge payable. The application fee applies to Traditional, Abbreviated, and Special 510(k)s. The payment of a premarket review fee is not related in any way to the final decision on a submission made by the FDA.
– 510(k) Exempt Devices
Most Class I devices and certain Class II devices are excluded from the Premarket Notification 510(k) submission.
– Third-Party Review
If you plan to apply a 510(k) application for a Class I or Class II device to the FDA, you can consider 510(k) review to be helpful by an Accredited Persons. The FDA has accredited 12 organizations to perform an initial review of 670 types of devices. By regulation, FDA will make a final decision within 30 days of obtaining an Accredited Person recommendation.
It should be noted that 510(k) review by an Accredited Person is excluded from any FDA fee; however, the third party can charge a fee for review thereof.
– Premarket Approval (PMA) – 21 CFR Part 814
Class III devices that require PMAs are high-risk devices that present a serious risk of disease or injury, or devices found not to be significantly equivalent to Class I and Class II predicates via the 510(k) process. The PMA process is more active and involves clinical evidence submission to support claims made for the device.
– PMA Review Fees
Medical device usage fees apply to original PMAs and other forms of PMA supplements beginning in fiscal year 2003 (October 1, 2002 through September 30, 2003). Small companies are entitled to have fees reduced or waived.
4. Investigational Device Exemption (IDE) - 21CFR Part 812
An investigational device exemption (IDE) requires the investigational device to be used in a clinical trial to obtain data on safety and effectiveness necessary to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA.
Before the research may begin, clinical trials with devices of serious risk must be approved by FDA and an Institutional Review Board (IRB). Studies with non-significant risk devices would only need to be approved by the IRB before the research can begin.
5. Quality System Regulation (QS regulation) - 21 CFR Part 820
The regulation of the quality system requires specifications relating to the methods used in and the facilities and controls used for: design, procurement, manufacture, packaging, labeling, storage, installation and servicing of medical devices. Manufacturing facilities undergo checks by the FDA to ensure compliance with the QS specifications.
6. Labeling - 21 CFR Part 801
Labeling involves device labels, as well as concise and detailed literature accompanying the device.
7. Medical Device Reporting - 21 CFR Part 803
Under the Medical Device Reporting program, incidents in which a device may have caused or resulted to serious injury or death must be informed to the FDA. Additionally, some malfunctions must be reported as well.
The MDR regulation provides FDA and manufacturers with a framework to detect and track serious adverse events involving medical devices. The regulation’s goals are to identify and resolve problems in a timely manner.
Final Thoughts
Any technical development and invention you can bring to the medical device industry, has to go through complicated enforcement and regulatory processes. The truth of the matter lies in the “safety and effectiveness of medical devices”.
For more information and news on FDA, please visit the FDA website : https://www.fda.gov/
