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发帖数: 25265 | 1 Federal Food, Drug, and Cosmetic ActFrom Wikipedia, the free encyclopedia (
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Federal Food, Drug, and Cosmetic Act
Acronym FFDCA, "FD&C Act"
Enacted by the 75th United States Congress
Citations
Public Law 75-717
Stat. 52 US Stat. 1040
Codification
U.S.C. sections created 21 U.S.C. § 301 et seq
Legislative history
Signed into law by President Franklin D. Roosevelt on June 25, 1938
Major amendments
1951 Food, Drug, and Cosmetics Act Amendments, PL 82–215, 65 Stat 648, 1962
Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat 780, Fair
Packaging and Labeling Act, PL 89–755, 80 Stat 1296, Medical Device
Regulation Act, PL 94–295, 90 Stat 539, Radiation Control for Safety and
Health Act, PL 90-602, 82 Stat 1173, Drug Price Competition and Patent Term
Restoration Act of 1984, PL 98-471, 98 Stat 1585, Nutrition Labeling and
Education Act (1990), PL 101-535, 104 Stat 2353, Safe Medical Device
Amendments of 1990, PL 101-629, 104 Stat 4511, Food and Drug Administration
Revitalization Act, PL 101-635, 104 Stat 4583, Dietary Supplement Health and
Education Act (1994), PL 103-417, 108 Stat 4332, Food and Drug
Administration Modernization Act of 1997, PL 105-115, 111 Stat 2296, Food
and Drug Administration Amendments Act of 2007, PL 110-85, 121 Stat 823[1]
Relevant Supreme Court cases
None
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA
, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving
authority to the U.S. Food and Drug Administration (FDA) to oversee the
safety of food, drugs, and cosmetics.[citation needed] A principal author of
this law was Royal S. Copeland, a three-term U.S. Senator from New York.[2]
In 1968, the Electronic Product Radiation Control provisions were added to
the FD&C. Also in that year the FDA formed the Drug Efficacy Study
Implementation (DESI) to incorporate into FD&C regulations the
recommendations from a National Academy of Sciences investigation of
effectiveness of previously marketed drugs.[3] The act has been amended many
times, most recently to add requirements about bioterrorism preparations.
The introduction of this act was influenced by the death of more than 100
patients due to a sulfanilamide medication where diethylene glycol was used
to dissolve the drug and make a liquid form.[4] See Elixir Sulfanilamide
disaster. It replaced the earlier Pure Food and Drug Act of 1906.
Contents [hide]
1 Contents
2 Food coloring
2.1 Certifiable colors
3 Food additives
3.1 Definition of food additive
3.2 Genetically modified foods are regarded as containing food additives
4 Homeopathic medications
5 Bottled water
6 Cosmetics
7 Section 510(k) and the device approval process
8 Related legislation
9 Significant amendments and related laws
10 Comparison to state laws
11 See also
12 References
13 External links
[edit] ContentsThe FD&C Act has twenty chapters:[5]
I. Short Title
II. Definitions
201(f) is the definition for a food, which explicitly includes chewing gum
201(g) is the definition for a drug
201(h) is the definition for a medical device
201(s) is the definition of a food additive
201(ff) is the definition of a dietary supplement
III. Prohibited Acts and Penalties
This section contains both civil law and criminal law clauses. Most
violations under the act are civil, though repeated, intentional, and
fraudulent violations are covered as criminal law. All violations of the FD&
C Act require interstate commerce because of the commerce clause, but this
is often interpreted broadly and few products other than raw produce are
considered outside of the scope of the act.
Notably, the FD&C Act uses strict liability due to the Dotterweich[6] and
Park [7] Supreme Court cases. It is one of a very small number of criminal
statutes that does.
IV. Food
There is a distinction in food adulteration between those that are added and
those that are naturally present. Substances that are added are held to a
stricter "may render (it) injurious to health" standard, whereas substances
that are naturally present need only be at a level that "does not ordinarily
render it injurious to health"[8]
V. Drugs and Devices
505 is the description of the drug approval process
510(k) is the section that allows for clearance of class II medical devices
515 is the description of the (class III) device approval process
VI. Cosmetics
VII. General Authority
704 allows inspections of regulated entities. Inspection results are
reported on Form 483.
VIII. Imports and Exports
IX. Miscellaneous
[edit] Food coloringThe FD&C is perhaps best known by the consumer because
of its use in the naming of food coloring additives, such as "FD&C Yellow No
. 6." The Act made the certification of some food color additives mandatory.
Some food colorings are generally recognized as safe (GRAS) by the FDA and
do not require certification.[9]
The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives
for use in foods in the United States, and numerous D&C (Drugs & Cosmetics)
colorings allowed only in drugs for external application or cosmetics. Color
additives derived from natural sources, such as vegetables, minerals or
animals, and man-made counterparts of natural derivatives, are exempt from
certification. Both artificial and natural color additives are subject to
rigorous standards of safety before their approval for use in foods.[
citation needed]
[edit] Certifiable colorsName Common name Color Comment
FD&C Blue No. 1 Brilliant Blue FCF bright blue
FD&C Blue No. 2 Indigotine royal blue
FD&C Green No. 3 Fast Green FCF sea green
FD&C Red No. 3 Erythrosine cherry red
FD&C Red No. 40 Allura Red AC orange-red
FD&C Yellow No. 5 Tartrazine lemon yellow
FD&C Yellow No. 6 Sunset Yellow FCF orange
Orange B Restricted to specific uses
Citrus Red No.2 Restricted to specific uses
There are also "D&C" colors that are only approved for use in
pharmaceuticals for external application and cosmetics.
[edit] Food additivesThe FFDCA requires producers of food additives to
demonstrate to a reasonable certainty that no harm will result from the
intended use of an additive. If the FDA finds an additive to be safe the
agency issues a regulation specifying the conditions under which the
additive may be safely used.
[edit] Definition of food additiveThe definition of "food additive" is "any
substance, the intended use of which results directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of food"[10]
. A food additive requires a premarket approval by the FDA unless excluded
from this requirement as a substance that is generally recognized, among
experts qualified by scientific training and experience to evaluate its
safety, as having been adequately shown through scientific procedures (or,
in the case of a substance used in food before January 1, 1958, through
either scientific procedures or through experience based on common use in
food) to be safe under the conditions of its intended use. This is the so
called generally recognized as safe (GRAS) exemption.[11]
[edit] Genetically modified foods are regarded as containing food
additivesThese regulations apply to foods produced by genetic engineering
and natural sources, if the protein added to the food by the genetic
engineering process is not "generally recognized as safe" then genetically
modified food is regarded as containing a "food additive" and is subject to
pre-market approval by the FDA.[12] All genetically modified foods sold in
the USA have been subject to this FDA pre-market approval process.
[edit] Homeopathic medicationsHomeopathic preparations are regulated and
protected under Sections 201(g) and 201(j), provided that such medications
are formulated from substances listed in the Homeopathic Pharmacopoeia of
the United States, which the Act recognizes as an official drug compendium.
[edit] Bottled waterBottled water is regulated by FDA as a food. The Agency
has published identity standards for types of water (mineral water, spring
water), and regulations covering water processing and bottling, water
quality and product labeling.[13][14] [15]
[edit] CosmeticsThis Act defines cosmetics as products for "cleansing,
beautifying, promoting attractiveness, or altering the appearance." In this
sense the FDA can classify cosmetics without actually regulating them. This
allows a manufacturer the ability to use ingredients or raw materials and
market the final product without government approval.
[edit] Section 510(k) and the device approval processSection 510(k)[16] of
the Federal Food, Drug, and Cosmetic Act requires those device manufacturers
who must register to notify FDA, at least 90 days in advance, of their
intent to market a medical device.
This is known as Premarket Notification - also called PMN or 510(k) . It
allows FDA to determine whether the device is equivalent to a device already
placed into one of the three classification categories. Thus, "new" devices
(not in commercial distribution prior to May 28, 1976) that have not been
classified can be properly identified.
Any device that reaches market via a 510(k) notification must be "
substantially equivalent" to a device on the market prior to May 28, 1976 (a
"predicate device"). If a device being submitted is significantly different
, relative to a pre-1976 device, in terms of design, material, chemical
composition, energy source, manufacturing process, or intended use, the
device nominally must go through a premarket approval, or PMA. This does not
always happen.
As of 2007, this has been implemented by splitting devices into three
classes:
Class I: Devices that do not require premarket approval or clearance but
must follow general controls. Dental floss is a class I device.
Class II: Devices that are cleared using the 510(k) process. Diagnostic
tests, cardiac catheters, and amalgam alloys used to fill cavities are all
class II devices. The "predicate device" in question is often quite
different, and this process is largely used to clear devices for marketing
which do not meet the criteria to be considered class III. Hearing aids are
class II devices.
Class III: Devices that are approved by the Premarket Approval (PMA) process
, analogous to a New Drug Application. These tend to be devices that are
permanently implanted into a human body or may be necessary to sustain life.
An artificial heart meets both criteria. The most commonly recognized class
III device is an Automated External Defibrillator. Devices that do not meet
either criterion are generally cleared as class II devices.
A device that reaches market via the 510(k) process is not considered to be
"approved" by the FDA. Nevertheless, it can be marketed and sold in the
United States. They are generally referred to as "cleared" or "510(k)
cleared" devices.
Most economists support pre-market approval of drugs and devices mainly
based on the belief that imperfect information exists on its market.[17]
[edit] Related legislationThe Wheeler-Lea Act, passed in 1938, granted the
Federal Trade Commission the authority to oversee advertising of all
products regulated by FDA, other than prescription drugs.
[edit] Significant amendments and related lawsDescriptions of these can be
found at the FDCA's web site.[18]
Amendments:
Infant Formula Act of 1980, Public Law (PL) 96-359 (Oct. 26, 1980)
Orphan Drug Act, PL 97-414 (Jan. 4, 1983)
Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-417 (
Sept. 24, 1984)
Prescription Drug Marketing Act of 1987, PL 100-293 (Aug. 18, 1988)
Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100-670 (Nov
. 16, 1988)
Nutrition Labeling and Education Act of 1990, PL 101-535 (Nov. 8, 1990)
Safe Medical Devices Act of 1990, PL 101-629 (Nov. 28, 1990)
Medical Device Amendments of 1992, PL 102-300 (June 16, 1992)
Prescription Drug User Fee Act (PDUFA) of 1992, PL 102-571 (Oct. 29, 1992)
Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103-396 (
Oct. 22, 1994)
Dietary Supplement Health and Education Act of 1994, PL 103-417 (Oct. 25,
1994)
Food Quality Protection Act of 1996, PL 104-170 (Aug. 3, 1996)
Animal Drug Availability Act of 1996, PL 104-250 (Oct. 9, 1996)
Food and Drug Administration Modernization Act (FDAMA) of 1997, PL 105-115 (
Nov. 21, 1997)
Best Pharmaceuticals for Children Act, PL 107-109 (Jan. 4, 2002)
Medical Device User Fee and Modernization Act (MDUFMA) of 2002, PL 107-250 (
Oct. 26, 2002)
Animal Drug User Fee Act of 2003, PL 108-130 (Feb. 20, 2003)
Pediatric Research Equity Act of 2003, PL 108-155 (Dec. 3, 2003)
Minor Use and Minor Species Animal Health Act of 2004
Food Allergen Labeling and Consumer Protection Act of 2004, PL 108-282 (Aug.
2, 2004)
Drug Efficacy Amendment ("Kefauver Harris Amendment") of 1962
Other laws:[19]
Federal Food and Drugs Act of 1906 (repealed; for historical reference)
Federal Meat Inspection Act (March 4, 1907)
Federal Trade Commission Act (Sept. 26, 1914)
Filled Milk Act (March 4, 1923)
Import Milk Act (Feb. 15, 1927)
Public Health Service Act (July 1, 1944)
Trademark Act of 1946 (July 5, 1946)
Reorganization Plan 1 of 1953 (March 12, 1953)
Poultry Products Inspection Act (Aug. 28, 1957)
Fair Packaging and Labeling Act (Nov. 3, 1966)
The National Environmental Policy Act of 1969 (Jan. 1, 1970)
Controlled Substances Act (Oct. 27, 1970)
Controlled Substances Import and Export Act (Oct. 27, 1970)
Egg Products Inspection Act (Dec. 29, 1970)
Lead-Based Paint Poisoning Prevention Act (Jan. 13, 1971)
Federal Advisory Committee Act (Oct. 6, 1972)
Government in the Sunshine Act (Sept. 13, 1976)
Government Patent Policy Act of 1980 (Dec. 12, 1980)
Federal Anti-Tampering Act (Oct. 13, 1983)
Sanitary Food Transportation Act (Nov. 3, 1990)
Mammography Quality Standards Act (MQSA) (Oct. 27, 1992)
Bioterrorism Act of 2002 (June 12, 2002)
Project BioShield Act of 2004 (July 21, 2004)
Food and Drug Administration Amendments Act of 2007
[edit] Comparison to state laws This section requires expansion.
Some US states have adopted the FD&C Act as an equivalent state law and will
by default adopt any changes to the Federal law as changes to the state law
as well.
[edit] See also100,000,000 Guinea Pigs (c. 1933 book which influenced
passage of this Act)
Food Administration
Food Quality Protection Act
Kefauver Harris Amendment
List of food additives
Office of Criminal Investigations
Pure Food and Drug Act
Regulation of therapeutic goods
Lake pigment
[edit] References1.^ "Food, Drug, and Cosmetic Law Research Guide,"
Georgetown Law Library
2.^ Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
3.^ CDER - Time Line
4.^ ASHP Website : News Article
5.^ Federal Food, Drug, and Cosmetics Act Table of Contents
6.^ United States v. Dotterweich, 320 U.S. 277 (1943)
7.^ UNITED STATES V. PARK, 421 U. S. 658 (1975) - US Supreme Court Cases
from Justia & Oyez
8.^ FD&C Act Chapter IV
9.^ US FDA/CFSAN: Color Additive Status List
10.^ [1] FDA website "Determining the Regulatory Status of a Food Ingredient
" Page Last Updated: 01/10/2011
11.^ Federal Register Volume 62, Number 74 (Thursday, April 17, 1997)
12.^ FDA/USDA US Food Safety System Country Report Annex II: Precaution in
US Food Safety Decisionmaking
13.^ Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and
the FDA." Food Safety. August/September 2002. ISSN 1084-5984.
14.^ FDA. "21 CFR Part 129 - Processing and Bottling of Bottled Drinking
Water." Code of Federal Regulations.
15.^ FDA. "21 CFR 165.110 - Requirements for Specific Standardized Beverages
16.^ US FDA/CDRH: Information on Releasable 510(k)s
17.^ Briggeman, Jason and Daniel Klein and Kevin Rollins. "44 Economists
Answer Questionnaire on the Pre-Market Approval of Drugs and Devices". Econ
Journal Watch 7(2) pg 162-173. [2]
18.^ Laws Enforced by the FDA and Related Statutes
19.^ Food and Drug Administration Amendment Act of 2007
http://en.wikipedia.org/wiki/510k#Section_510.28k.29_and_the_de | l*****f
发帖数: 359 | 2 how come medical device is regulated by FDA?
It's not food or drug, is it?
(
【在 s**********8 的大作中提到】
: Federal Food, Drug, and Cosmetic ActFrom Wikipedia, the free encyclopedia (
: Redirected from 510k)
: Jump to: navigation, search
: This article may require cleanup to meet Wikipedia's quality standards.
: Please improve this article if you can. The talk page may contain
: suggestions. (February 2011)
: Federal Food, Drug, and Cosmetic Act
: Acronym FFDCA, "FD&C Act"
: Enacted by the 75th United States Congress
: Citations
| s**********8
发帖数: 25265 | 3 .....FDA regulates all health care products, dont just go with names.
CDER: center for drug evalutation and research, basically small molecule
chemical drug
CBER: center for biologics evaluation and research.
CDRH: center for devices and radigological health
【在 l*****f 的大作中提到】
: how come medical device is regulated by FDA?
: It's not food or drug, is it?
:
: (
| l*****f
发帖数: 359 | 4 so health insurance is a health care product
is it regulated by FDA also?
- serious student
【在 s**********8 的大作中提到】
: .....FDA regulates all health care products, dont just go with names.
: CDER: center for drug evalutation and research, basically small molecule
: chemical drug
: CBER: center for biologics evaluation and research.
: CDRH: center for devices and radigological health
| s**********8
发帖数: 25265 | 5 no, it's not science based.
FDA's mission is to protect public safety, not their wallet.
insurance should be regualted by state and federal law
【在 l*****f 的大作中提到】
: so health insurance is a health care product
: is it regulated by FDA also?
: - serious student
| l*****f
发帖数: 359 | 6 makes a lot sense!
【在 s**********8 的大作中提到】
: no, it's not science based.
: FDA's mission is to protect public safety, not their wallet.
: insurance should be regualted by state and federal law
|
|
