In the last newsletter (See Archives!), you learned how the U.S. Food and Drug Administration (FDA) classified medical devices into one of three classes: General Controls, Special Controls and Premarket Approval.

You also learned how to find the appropriate classification for your product and find its product code.  In this column, we will learn about the general regulatory requirements for each of the three classes. 

Class I Devices

Class I medical devices are the least regulated by the FDA.  This is because such devices are the least likely to injure the user.  These products tend to be simple in design.  Examples include a surgeon’s glove and manual surgical instruments. Regulatory control increases from Class I to Class III.

Most Class I devices are exempt from the premarket notification [510(k)] requirements. This is the requirement to make a submission to the FDA of information that will allow the FDA to determine that your product is “substantially equivalent” to a device legally marketed in the U.S.  We will discuss detailed requirements for submitting a “510(k)” in a future column.  It is very important to look carefully at the regulation to see if there are limitations on the exemption.  For example, let’s look at 21Code of Federal Regulations (CFR), Sec. 888.1100 Arthroscope.

(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

(b) Classification. (1) Class II (performance standards).  (2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in Sec. 888.9.

As you can see, the Class 1 exemption only covers certain manual arthroscopic instruments.  Electrically powered ones are not exempt. They are class II devices.  Furthermore, Section 888.9 lists other limitations where the exemption may not apply.  For example, if your device is used for a different medical purpose than the exempt product or uses a different fundamental technology, it would not be exempt.  We often say that when you read a legal contract, “read the fine print”.  This is true about exemptions, too!

A few Class I devices are additionally exempt from the good manufacturing practices (GMP) requirements except for complaint files and general record keeping requirements. These are specially marked if exempt and do not cover devices that are labeled or represented as being sterile! Non-exempt products must conform to the requirements of the Quality Systems Regulation (QSR), which establishes the requirements for good manufacturing practices.  Keep in mind that these devices are not exempt from other general controls. See the next section.

The FDA has specifically determined that some class I devices are not exempt.  These are called “Reserved Devices”.  See, for example, http://www.fda.gov/cdrh/modact/fr011400.html for a list.

General Controls

General Controls refer to the regulatory controls provided by the medical device law to give the FDA with the tools to ensure the safety and effectiveness of devices.

General Controls apply to all three classes of medical devices. For Class I devices, however, they are the only level of controls that apply.

General Controls include:

1. Establishment Registration (See Archives)

2. Medical Device Listing (See Archives)

3. Adulteration

4. Misbranding

5. Premarket Notification for non-exempt devices

6. Banned Devices

7. Notification and Repair, Replacement and Refund

8. Records and Reports

9. Restricted Devices

10. General Provisions, including Good Manufacturing Practices

We will discuss these provisions in more detail in the next column.  As always, contact me at yourFDAconsultant@medisourceasia.com if you have any questions or comments.

Class II Devices–Special Controls 

Class II medical devices are subject to the same general controls outlined above as for Class I devices but are also subject to Special Controls.  This is because the FDA believes that Class II devices require more regulation to assure their safety and effectiveness.

As we have seen, most Class I devices are exempt from Premarket Notification 510(k) requirements. In contrast, most Class II devices require Premarket Notification 510(k) clearance before they can be marketed in the U.S.A. A summary of the exempted Class II devices can be found at: http://www.fda.gov/cdrh/modact/frclass2.html.  We will discuss the requirements for 510(k) submissions in future columns.  Special controls may also include special labeling requirements, mandatory performance standards and postmarket surveillance.

Class III Devices - Premarket Approval 

Medical devices for which insufficient information can be provided through general or special controls are placed in Class III. Devices in this class, for example, support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Class III products require FDA approval of a Premarket Approval (PMA) application before a product can be marketed.  Premarket approval is a much more complex process than submission of a 510(k).  It involves the design and implementation of extremely high quality clinical studies and a scientific review by the FDA as well as review by an Advisory Committee selected by the FDA. Approval is granted by the FDA if the PMA is found to contain valid scientific evidence that the device is safe and effective for its intended use. Unlike a 510(k), a PMA can act as a private license to the applicant to market the product.

Some Class III devices do not need an approved premarket approval application to be marketed. These exceptions and the Premarket approval process will be discussed in a future column.

In the next issue, we will discuss General Controls in more detail.

Have a happy, healthy and fulfilled new year!

Norman F. Estrin, PhD, RAC

December 15, 2002