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Overview: FDA Regulation of Medical Devices
The following information is provided as general guidance to the Food and
Drug Administration (FDA) regulation of medical devices. The Center for
Devices and Radiological Health (CDRH) is the division of FDA responsible
for medical device regulation. CDRH maintains a very informative web site.
The CDRH web site is located at: http://www.fda.gov/cdrh/devadvice/default.htm.
For support in working with the FDA and applicable regulations/
interpretation, contact:
Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
E-mail: Q********[email protected]
Phone: 608 877-2635
Fax: 608 873-7382
http://www.qrasupport.com
Many of the regulations enforced by the Food and Drug Administration (FDA)
with regard to medical devices can be found in Title 21 Code of Federal
Regulations (CFR) Part 800 to Part 1299. This reference is abbreviated to 21
CFR 800 to 1299.
Medical Device Definition
A medical device is defined within the Food Drug & Cosmetic Act as "...an
instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or
accessory which is: recognized in the official National Formulary, or the
United States Pharmacopoeia, or any supplement to them, intended for use in
the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals, or intended to
affect the structure or any function of the body of man or other animals,
and which does not achieve any of it's primary intended purposes through
chemical action within or on the body of man or other animals and which is
not dependent upon being metabolized for the achievement of any of its
primary intended purposes."
Medical devices distributed in the United Sates are subject to General
Controls, pre-marketing and post marketing regulatory controls.
General Controls include:
Establishment Registration by manufacturers, distributors, repackages
and re-labelers,
Medical Device Listing with FDA of devices to be marketed,
Manufacturing the devices in accordance with Good Manufacturing
Practices,
Labeling medical devices in accordance with the labeling regulations, 21
CFR 801 or 21 CFR 809,
Medical Device Reporting of adverse events as identified by the user,
manufacturer and/or distributor of the medial device.
Pre-marketing controls are device and device classification specific. Pre-
marketing controls for a medical device may include: clearance to market by
510(k) or approval to market by Pre-Market Approval (PMA). Post marketing
controls include Device Listing, Medical Device Reporting (MDR),
Establishment Registration and Quality System Compliance Inspection.
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Device Classification
There are 3 FDA regulatory classifications of medical devices: Class I,
Class II and Class III. The classifications are assigned by the risk the
medical device presents to the patient and the level of regulatory control
the FDA determines is needed to legally market the device. As the
classification level increases, the risk to the patient and FDA regulatory
control increase. Accessories to medical devices, devices used with a
medical device to support use of the device, are considered the same
classification as the medical device.
The FDA classification of medical devices is based upon classifications for
devices currently legally marketed in the United States. The FDA determines
the device classification by the device intended use and risk the device
presents to the patient. New medical devices are compared to legally
marketed medical device classifications with the same intended use and
technological characteristics to determine the device classification.
Class I medical devices have the least amount of regulatory control. Class I
devices present minimal potential harm to the user. Class I devices are
typically simple in design, manufacture and have a history of safe use.
Examples of Class I devices include tongue depressors, arm slings, and hand-
held surgical instruments. Most Class I devices are exempt from the
premarket notification and may be exempt from compliance with the good
manufacturing practices regulation.
Class II medical devices are devices where General Controls are not
sufficient to assure safety and effectiveness and existing methods/standards
/guidance documents are available to provide assurances of safety and
effectiveness. In addition to compliance with General Controls, Class II
devices are required to comply with Special Controls. Special Controls
include:
Special labeling requirements,
Mandatory performance standards, both International and United States
Postmarket surveillance
FDA medical device specific guidance
Class II devices typically require pre-market notification by submission and
FDA review of a 510(k) clearance to market submission. A few Class II
devices are exempt from the premarket notification. Information on Class II
exempt devices is located within the device regulation, 21 CFR 862 through
892. Examples of Class II devices include physiologic monitors, x-ray
systems, gas analyzers, pumps, and surgical drapes.
Class III medical devices have the most stringent regulatory controls. For
Class III medical devices, sufficient information is not available to assure
safety and effectiveness through the application of General Controls and
Special Controls. Class III devices usually support or sustain human life,
are of substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury to the patient.
Typically a Pre-Market Approval (PMA) submission to the FDA is required to
allow marketing of a Class III medical device. A few Class III medical
devices are required to only have a 510(k) cleared by the FDA to be marketed
. Examples of Class III devices that require a PMA are: replacement heart
valves, silicone gel-filled breast implants, and implanted cerebella
stimulators.
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510(k) Clearance to Market
The majority of Class II medical devices are cleared to market by submission
and FDA review of a 510(k) Pre-Market Notification submission. The 510(k)
submission identifies characteristics of the new or modified medical device
as compared to a medical device with similar intended use, currently legally
marketed in the United States. The currently legally marketed device is
referred to as the “predicate” device.
The information required in a 510(k) submission is defined 21 CFR 807.87. A
510(k) submission includes:
Device trade or proprietary name, common or usual name or classification
, Class of the device (Class I, II, III)
Submitter's name and address, Contact person, telephone number and fax
number, Representative/Consultant if applicable
Name and address of manufacturing/packaging/sterilization facilities,
Registration number of each manufacturing facility
Action taken to comply with the requirements of the Special Controls.
Proposed labels, labeling, and advertisements to describe the device,
its intended use, and the directions for its use.
510(k) summary or a 510(k) statement.
For Class III medical device, a Class III certification and a Class III
summary.
Photographs of the device, Engineering drawings of the device.
Identification of the marketed device(s) to which equivalence is claimed
including labeling and description of the medical device.
Statement of similarities and/or differences with marketed device(s)
Data to show consequences and effects of a modified device, performance
Data (bench, animal, clinical)
Sterilization information (as applicable)
Software development, verification and validation information
Hardware design and development information
Information requested in specific guidance documents (as applicable)
Kit Certification Statement (for a 510(k) submission with kit components
only)
Truthful and Accurate Statement
Depending on the complexity of the new or modified medical device, the FDA
Review of a 510(k) submission takes between 20 and 90+ days. The more
complex the changes or comparison required to support the safety and
effectiveness of the new or modified medical device, the longer the FDA
review process.
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PMA (Pre-Market Approval)
A PMA is required for FDA Approval of medical devices that present
significant risk to the patient and/or require significant scientific review
of the safety and effectiveness of the medical device prior to commercial
introduction. Most Class III medical devices require a PMA. Section 515(c)(1
) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) specifies the
required contents of a PMA. PMA application content includes:
full reports of all information, published or known to or which should
reasonably be known to the applicant, concerning investigations which have
been made to show whether or not such device is safe and effective;
a full statement of the components, ingredients, and properties and of
the principle or principles of operation, of such device;
a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and, when relevant, packing
and installation of such device;
an identifying reference to any performance standard under Section 514
which would be applicable to any aspect of such device if it were a Class II
device, and either adequate information to show that such aspect of such
device fully meets such performance standard or adequate information to
justify any deviation from such standards;
such samples of such device and of components thereof as the Secretary
may reasonably require, except that where the submission of such samples is
impracticable or unduly burdensome, the requirement of this subparagraph may
be met by the submission of complete information concerning the location of
one or more such devices readily available for examination and testing;
specimens of the labeling proposed to be used for such device; and
such other information relevant to the subject matter of the application
as the Secretary, with the concurrence of the appropriate panel under
Section 513, may require.
The FDA has a statutory 180-day review cycle for PMA applications. Often PMA
applications require medical advisory board review prior to the FDA
granting approval to market the medical device. A facility inspection
verifying the manufacturing systems present to manufacture the medical
device is usually performed prior to FDA PMA approval. FDA approval of a PMA
often requires significantly more than 180 days.
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Good Manufacturing Compliance(GMP)Compliance
The Good Manufacturing Practice (GMP) requirements are defined in 21 CFR 820
. The GMP is also referred to as the Quality System (QS) Regulation. A
quality system is required for the design, manufacture, packaging, labeling,
storage, installation, and servicing of finished medical devices intended
for commercial distribution in the United States. The QS Regulation is
similar to ISO 9001:1994, with FDA particular requirements. The QS
Regulation covers:
quality management and organization,
device design,
buildings,
equipment,
purchase and handling of components,
production and process controls,
packaging and labeling control,
device evaluation,
distribution,
installation,
complaint handling,
servicing,
records.
The FDA may audit the manufacturing facility for GMP compliance every 2
years. FDA compliance inspections are based upon results of prior audits,
device risks, recall of devices and FDA initiatives in regard to particular
classifications of devices.
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Establishment Registration
Establishments involved in the production and distribution of medical
devices intended for marketing in the United States are required to register
with the FDA. Establishment Registration requirements are defined in 21 CFR
807. Establishment Registrations are verified and updated annually.
Foreign establishments engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported, or offered for
import, into the United States must register their establishments and
provide the FDA with the name of the United States agent representing their
establishment. Foreign establishments must provide FDA with a list of the
devices that they are exporting to the United States.
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Device Listing
Most medical device establishments required to register with FDA must list
the devices they have in commercial distribution. Medical device listing is
completed by the classification name the FDA has assigned to the medical
device, see 21 CFR Part 862 to 892.
Device listing should be completed within 30 days of entering a device into
commercial distribution in the United States. Device listing is updated when
a new classification of device is entered into commercial distribution, the
marketing of a device classification is discontinued, or marketing of a
discontinued device is started again.
Medical Device Reporting(MDR)
The Medical Device Reporting (MDR) regulation requires firms who have
received complaints of device malfunctions, serious injuries or deaths
associated with medical devices to notify FDA of the incident. The
requirements for medical device reporting are defined in 21 CFR 803. The
regulation requires:
A written MDR procedure,
MDR event files,
Individual adverse event reports,
5 day MDR reports of remedial action taken to prevent unreasonable risk
of substantial harm to public health,
30-day MDR reports of deaths, serious injuries and malfunction
attributed to the medical device,
Baseline reports for the medical device. |
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