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Small Business Guide to FDA
(last revised on 03/31/04)

WHAT TO DO WHEN

 

Marketing a New Product
FDA must give the manufacturer, distributor or importer clearance to market certain products before they can be sold in interstate commerce. For example:

  • New human and veterinary drugs ["New" drugs = those with new intended uses or new chemical entities] and certain medical devices [examples = stair-climbing wheelchair, contact lens, heart pacemaker] must be approved for safety and effectiveness, and their labeling reviewed for accuracy and thoroughness.
  • Substances added to food must meet the requirements of the food additive regulations that are based on FDA's review of scientific data of safety and utility that have been submitted to FDA.
  • All domestic and foreign facilities that manufacture/process, pack, or hold food (and dietary supplements) for human or animal consumption in the United States must register with the FDA. For more information on starting a food business see http://www.cfsan.fda.gov/~comm/foodbiz.html.
  • In addition, manufacturers of low-acid canned foods* packaged in air-tight bottles, plastic bags, and cans and acidified foods** must register with FDA and submit detailed information about heat-treatments to destroy bacteria (and acidification, if necessary to prevent growth of bacterial spores).
  • Specific premarket controls apply to biological products that are required to be licensed under Federal law.

Marketing these kinds of products or conducting experimental investigations with them in human clinical trials, requires that one or more applications be filed with FDA and that certain procedures be followed.

In addition, although some products [such as cosmetics and some radiation-emitting items] do not need premarket approval from FDA, there are regulatory standards and regulations applicable to their manufacture and labeling that fall under FDA's jurisdiction. Therefore, to avoid unnecessary delay in bringing new products to market, it would be helpful to talk with an FDA product specialist early in your planning. (See Who to Contact for Assistance for the most appropriate contact).


PRODUCTS THAT REQUIRE REGISTRATION, LISTING, FILING OF A COOKING PROCESS, OR LICENSING PRIOR TO MARKETING:


HANDLING AN FDA INSPECTION

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present his/her credentials and "Notice of Inspection" upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions.

Usually, the investigator will examine your production process, look at certain records and collect samples. At the conclusion of the inspection, the investigator will discuss with your firm's management any significant findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator’s judgment, indicate objectionable conditions, or practices. This list of "Inspectional Observations," also called an FDA-483, can be used by your firm's management as a guide for corrective action, since the FDA representative will not usually recommend specific corrective measures. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.

If you do not agree with the actions being taken by the FDA or if you have a question about the jurisdiction of the agency in a particular matter, you can contact the FDA's Office of the Ombudsman to seek a resolution.

  • Office of the Ombudsman
    Food and Drug Administration
    5600 Fishers Lane
    Room 14B03, HF-7
    Rockville, MD 20857
    Telephone: 301-827-3390
    FAX: 301-480-8039
    E-mail: ombudsma@oc.fda.gov [Sending confidential information by electronic mail is not recommended.]

See the FDA Center Small Business Contacts for the Ombudsman in the various FDA Centers. If FDA takes regulatory action against your firm, the Small Business Representatives are not available for guidance, since their activities are nonregulatory in nature. You should contact a district Compliance Officer for advice (see FDA District Offices) under those circumstances.

Recalling Violative Products

A "recall" is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which FDA would initiate a regulatory action such as seizure of the product. During a recall, a firm can expect to work more closely with FDA than under almost any other circumstance. In fact, the first step, when a product must be recalled, is for the manufacturer or distributor to call the nearest FDA field office and talk with the Recall Coordinator. See list of FDA District Offices.

FDA's main concerns during a recall are that the firm has determined the location of the product and organized the prompt removal from commerce of any suspect lots. FDA will then work with the firm to identify the cause of the problem and the corrections needed to prevent a recurrence.
FDA is also concerned about the final disposition of the recalled product. Final disposition may be in the form of destruction, with appropriate regard for local laws concerning waste removal or incineration. Other possible conclusions to recalls include reconditioning (relabeling, repacking, reworking, etc.) or exportation, if permitted. Any method used must first be discussed with the FDA District Office, as FDA may wish to witness the effort, and the firm must maintain proper documentation.

Also with device recalls, the firm must report to the FDA District Office any Corrections or Removals in accordance with 21 CFR 806.10 as soon as the firm becomes aware of the problem.

Essentially, the procedures for a product recall are determined by the individual company; however, a proper recall system will include provisions for record-keeping, handling product returns, liaison with FDA, and public information. The efficiency of tracking and removing a product depends on the completeness of the records maintained throughout the production and distribution process.

Information on Recalls of FDA Regulated Products: http://www.fda.gov/ora/compliance_ref/recalls/recallpg.html

Professional Demeanor of FDA Employee:
If you are concerned about the professional demeanor of any FDA employee during an inspection or during their performance of other official duties, you should contact the District Director in the nearest FDA field office to resolve your concerns. See LIST OF DISTRICT DIRECTORS.