In the last column, we discussed the adulteration and misbranding (including False and Misleading Labeling) General Controls requirements for medical devices.  Here are the General Controls we discussed and those we will discuss in this column:

1. Establishment Registration (See Archives)

2. Medical Device Listing (See Archives)

3. Adulteration (See Archives)

4. Misbranding (Including False and Misleading Labeling) (See Archives)

5. Banned Devices (This Column)

6. Notification and Repair, Replacement and Refund (This Column)

7. Records and Reports (This Column)

8. Restricted Devices (This Column)

9. General Provisions, including Good Manufacturing Practices (Future Column)

10. Premarket Notification for non-exempt devices (Future Column)

Banned Devices

The FDA gets its authority to ban medical devices from Section 516 of the Federal Food, Drug & Cosmetic Act of 1938 (FD&C Act).   A device can be banned after the FDA determines that a device that is intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury.  The FDA makes such determinations after reviewing all available data and information and after consulting the appropriate classification panel of experts.  These determinations are published in a Federal Register proposal to ban the device.  After a final regulation is published in the Federal Register, the regulation is published in the Code of Federal Regulations (CFR). For example, here is the regulation banning prosthetic hair fibers:

PART 895--BANNED DEVICES--Table of Contents
Subpart B--Listing of Banned Devices
Sec. 895.101 Prosthetic hair fibers.

Prosthetic hair fibers are devices intended for implantation into  the human scalp to simulate natural hair or conceal baldness. Prosthetic hair fibers may consist of various materials; for example, synthetic fibers, such as monacrylic, polyacrylic, and polyester; and natural fibers, such as processed human hair. Excluded from the banned device are natural hair transplants, in which a person's hair and its surrounding tissue are surgically removed from one location on the person's scalp and then grafted onto another area of the person's scalp.

[48 Federal Register 25136, June 3, 1983]

The FDA can also ban a device if it determines that the deception or unreasonable and substantial risk of illness and injury can be corrected or eliminated by labeling and so notifies the manufacturer, who does not implement the required changes within the specified time period.  An informal hearing with all interested parties will be followed by a decision by the FDA to affirm, modify, or revoke the proposed regulation.  If the proposed ban is revoked, a notice to that effect will be published in the Federal Register. If its proposed regulation is affirmed or modified, The FDA will then publish a final regulation banning the device. On the date of publication of the final regulation, the device can no longer be legally marketed unless the company has received an approved investigational device exemption.  (We will discuss this exception at a later time).

Notification and Repair, Replacement and Refund

The FDA helps protect the public from faulty or fraudulent devices under the authority it receives from Section 518 of the FD&C Act.  Its goal is to help ensure that hazardous products in the hands of consumers are repaired or replaced or that the consumer gets a refund for a defective product.

Notification [518(a)]

Section 518(a) of the FD&C Act, gives the FDA authority to require manufacturers or other appropriate individuals to notify all health professionals who prescribe or use the device and any other person (including manufacturers, importers, distributors, retailers, and device users) of the health risks resulting from the use of a faulty or fraudulent device, so that these risks may be reduced or eliminated.

The FDA can order notification if it determines that:

1. A device intended for human use presents an unreasonable risk of substantial harm to public health;

2. Notification is necessary to eliminate the risk and no more practicable means are available under the FD&C Act to eliminate the risk.

The FDA only has to consult with the persons who are to provide the notification in order to initiate these provisions.

Repair, Replacement, or Refund Provisions [518(b)]

Under Section 518(b) of the FD&C Act, the FDA, after offering an opportunity for an informal hearing, can order manufacturers, importers, or distributors to repair, replace, or refund the purchase price of devices that present unreasonable health risks.

The FDA must first show that a medical device intended for human use:

• Represents an unreasonable risk of substantial harm to the public health;

• Was not designed and manufactured in accordance with the then prevailing state of the art;

• Presents a risk that is not due to negligent installation, maintenance, repair, or use of the device by persons other than a manufacturer, importer, distributor, or retailer

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