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The FDA must also determine that notification alone is insufficient, and repair, replacement, or refund is necessary and consider available alternatives, including legal actions (seizures, injunctions, prosecutions), regulations (e.g., banning or imposing restrictions on sale, distribution or use) and recalls (under FDA's recall regulations).

The procedures for repair, replacement, or refund are complex and could result in multiple orders, regulatory hearings, and many delays if FDA and the manufacturer, or other responsible person, are unable to agree on a plan for addressing a risk. The FDA must consider available alternatives and must determine that no more practical means are available under the FD&C Act to eliminate the risk.

Records and Reports

Section 519 of the FD&C Act authorizes the FDA to promulgate regulations requiring manufacturers, importers, and distributors of devices to maintain records and reports to assure that devices are not adulterated or misbranded.

Under Section 519, the FDA:

• Shall not impose requirements that are unduly burdensome to the manufacturer, importer, or distributor;

• Must state the reason and purpose for procedures requesting reports or information;

• Must state the reason and purpose for submission of reports or information;

• May not require that the identity of any patient be disclosed; and

• May not require a manufacturer, importer, or distributor to maintain or submit reports or information not in his/her possession.

Excluded from these requirements are practitioners who prescribe or administer devices solely in the course of their professional practice, manufacturers or importers of devices used solely in research or teaching and other persons exempt by regulation.

Section 520(e) of the FD&C Act gives the FDA the authority to restrict the sale, distribution, or use of a device if there cannot otherwise be a reasonable assurance of its safety and effectiveness. A restricted device can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation. The label of a restricted device must bear the appropriate statements of the nature of the restrictions, as required by regulation.

Quality System Regulation, Good Manufacturing Practices

  Section 520(f) of the FD&C Act authorizes the FDA to promulgate regulations requiring the methods used in, and the facilities and controls used for, the manufacturing, packing, storage, and installation of a device to conform to current good manufacturing practices (GMPs). The Safe Medical Devices Act of 1990 (SMDA) amended section 520(f) of the Act and gave the FDA authority to issue regulations requiring pre-production design controls. This change in the law was necessary because of the discovery that a significant proportion of device recalls were the result of a faulty design. The FDA revised its current good manufacturing practice requirements to include pre-production design controls that device manufacturers must follow when initially designing devices or when making subsequent modifications to those designs. (See http://www.fda.gov/cdrh/qsr/contnt.html )  We will discuss these requirements in future columns in more detail.

Premarket Notification Requirements

Section 510(k) of the FD&C Act requires a manufacturer who intends to market a medical device to submit a premarket notification (a “510(k)”) to the Agency at least 90 days before introducing the device onto the market. The FDA will review the information to determine whether the device is substantially equivalent to a device legally marketed in the United States.  We will begin our discussion of these requirements in my next column.

As always, I welcome your questions and comments.

Norman F. Estrin, PhD, RAC

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