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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.
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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.
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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.
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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:
- 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 to satisfy the Bioterrorism
Act of 2002. The agency highly recommends on line registration at
http://www.cfsan.fda.gov/~dms/fsbtact.html. You must register using
Form 3537. If you do not have reasonable access to the Internet,
you may obtain a copy of this form by writing to the U.S. Food and
Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857,
or by requesting the form by phone at 800-216-7331 or 301-575-0156.
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Low Acid Canned
Foods [LACF]* such as traditional vegetables, or any
other food requiring aseptic processing to control the growth of pathogens
must register all manufacturing establishments and file all scheduled
processes. [To order forms 2541, 2541c: via phone 202-205-5282 or
via Internet at http://forms.psc.gov/forms/FDA/FDA-2541.pdf, http://forms.psc.gov/forms/FDA/FDA-2541c.pdf]
- Drugs including medical gases, human and veterinary prescription drugs,
over-the-counter [OTC] drugs, and certain biologics must register
all establishments and list all drug products. [To order forms 2656,
2657, or 2658: Via phone at 301-594-1086 or via Internet at http://forms.psc.gov/forms/FDA/FDA-2656.pdf,
http://forms.psc.gov/forms/FDA/FDA-2657.pdf, http://forms.psc.gov/forms/FDA/FDA-2658.pdf]
-
Devices - human and animal devices must register all establishments
and list all drug products. [To order forms 2891 or 2892: Via FAX:
301-443-8818 or via Internet (2891 only) http://www.fda.gov/cdrh/comp/fda2891.pdf]
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Biologics and Blood
Banks - human biologics may also be considered
a drug or device and subject to the requirements of a drug or device.
[Phone for forms: 301-827-3546]* USDA regulates biologics for animals.
Many biologics establishments require licensing as well.
*Some forms only available by mail from [NO phone/FAX orders]:
Consolidated Forms and Publications Distribution Center [CFPDC]
Beltsville Service Center
6351 Ammendale Road
Beltsville, MD 20705
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.
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