Editor’s Note: This is a guest post contributed by ONYX Healthcare USA, Inc.

 
There have been several innovations in the medical device & equipment sector in the last decade, so there are now a range of exciting new technologies on the market.   However, medical equipment in the US must undergo rigorous testing, and obtain the necessary certification before going to market.  But how does medical equipment get certification.

The medical device market in the US is governed by various regulations and standards, all designed to ensure patient safety.  The regulatory requirements involve approval from different agencies, at various stages of development and marketing.

Medical Equipment & Device Certification: Why It Matters

Certification is critical in order to safeguard clinicians and keep patients safe.  Many medical devices are used in proximity to patients whether at the bedside, or in the operating room, so they must be free of any hazards that could compromise safety.  That’s why devices have to be certified as safe for the medical environment.

Certification also guarantees reliability, ensuring that the medical device won’t malfunction and cause any harm to staff or patients.

Medical devices can earn certification as long as they satisfy the guidelines set out by the relevant regulatory agencies.  Among the most important certifications for device manufacturers doing business in the American market are those from the International Standards Organization (ISO), the Federal Communications Commission (FCC), and Food & Drug Administration (FDA).

1. UL IEC 60601-1 Certification

Medical devices have to meet international regulatory standards set by the International Electrotechnical Commission. UL 60601-1 certification sets out standards designed to verify the basic safety and essential performance of a medical device for use in the United States.

To gain 60601-1 certification, medical device manufacturers have to develop a risk analysis based on ISO 14971.  The risk analysis results are then submitted to a testing lab in the form of a Risk Management File (RMF).  The lab will test and evaluate the product using established parameters, to determine if it is acceptable, and meets the required standards. Similar tests are done for home medical devices.  Once the device is compliant with IEC 60601-1 standards, the manufacturer can put the UL certification mark on their product.

2. Federal Communications Commission (FCC) Rules & Regulations

The FCC oversees medical devices that use radio technology, as the commission manages the electromagnetic spectrum.  FCC certification ensures that the device meets standards relating to emissions, and is compatible with other users on the spectrum.

FCC Testing

The device is tested to ensure that it broadcasts within the right radio frequency range, meets the general requirements of the telecommunication sector, and does not interfere with other equipment.  After it’s been confirmed that the requisite FCC requirements have been met, the medical device manufacturer can apply for FCC certification.

FCC Classification of Medical Devices

FCC has two classifications for medical devices – Class A and Class B.  Class A devices are those marketed for use in a hospital, while Class B devices are marketed for residential use.  Medical device manufacturers have to register with the FCC, and the relevant testing is done by a FCC registered testing facility.

3. U.S. Food and Drug Administration (FDA) Regulations

The U.S. Food and Drug Administration (FDA) regulates medical devices (here is the FDA’s definition of a medical device) and harmonizes the various requirements, so products have to gain FDA approval before being marketed in the US.  The developer has to first submit a pre-market 510(k) notification to the FDA.

FDA Approval Process

In order to gain approval, the company must establish that the device is safe and effective for the specified use.  A 510(k) approval is also required for a device that was previously cleared, but subsequently altered in a manner that could affect its safety or effectiveness.

FDA Classification of Medical Devices

The FDA has classifications for about 1,700 different generic types of devices, which are grouped into 16 medical specialties (referred to as panels). Each generic type of medical device is then assigned to one of three regulatory classes, which is determined based on the “level of control necessary to assure the safety and effectiveness of the device.” The three classifications are:

• Class I – General Controls
• Class II – General Controls and Special Controls
• Class III – General Controls and Premarket Approval

The classification of the device also depends on its indications for use.

When the medical device has gone through the process of verification and validation, FDA approval is granted.  This guarantees total safety, so there is no risk to staff or patients.

About ONYX Healthcare USA, Inc.

Contact ONYX Healthcare USA, Inc. for more information on certified medical devices.  ONYX Healthcare is a leading manufacturer of medical devices. They have a complete line of medical products that have received certification from the relevant agencies. You can reach them at http://www.onyxhealthcareusa.com, or by calling 714-792-0774.