Kory Razaghi

A Member of the Healthcare Financial Management Association

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Medical devices and the FDA

Medical devices constitute a very huge and complex field. Devices can range from anything between a thermometer and a pacemaker. The FDA, the US' food and drug regulatory body, has a definition for devices. It considers a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1) Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

2) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

The FDA has a stellar role in regulating the medical devices industry. It is the sole regulatory body for medical devices, a role it has assumed considering the serious health implications even a small fault in a device can cause.

What is meant by FDA approval?

An FDA approval for medical devices means that the said product is ready and certified as being ready for marketing. Any and every manufacturer has to get FDA approval for marketing adevice. It has to get this clearance through a premarket notification, or what is called 510 (K). The FDA will clear the device that has been sent to it for approval, or reject it. If the device meets the stringent criteria set by the FDA for approval, then it is considered an approved.

What a cleared or approved medical device means is that the FDA deems it to be at least as safe as another device that has already been marketed and is put to the same use. The application for this clearance should have proof to show that the present medical device, whose clearance is sought, exhibits this quality.

Is 510(K) necessary for all medical devices?

The answer is 'no'. Not all devices need to go through a 510(K) process. Devices that are classified under, meaning those that pose the least risk to the user do not need 510 (K). Only a few Class II and all Class III devices, which entail a higher risk to the user, are subject to a 510 (K) premarket approval (PMA).

What are general controls?

Being exempt from 510 (K) premarket approval process means that the medical device is not required to obtain the PMA; however, there are what are called general controls, which any device has to comply with. These are some of them:

1) The medical device should be fit for its intended use;

2) It should be satisfactorily packaged and clearly labeled;

3) It should carry its manufacturer's name and registration, as well as the listing forms meant for devices with the FDA;

4) It should be manufactured in accordance with the established requirements, expect in the case of a few Class I for which a few recordkeeping requirements or general files will suffice.

Aptus Advisors, Inc.

Aptus Advisors, Inc is a healthcare consulting firm headed by Kory Razaghi providing corporate finance, management, and operational turnaround services to healthcare organizations including community, children’s, government/public, and critical access hospitals, as well as physician groups, and healthcare sector focused private equity firms. Since 2006, Aptus Advisors has provided practical solutions to the myriad of challenges faced by its healthcare clients to enable sustainable growth, profitability, and long-term competitive advantage.