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发帖数: 25265 | 1 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Device Classification
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s1 and Premarket Approvals2
Classify Your Medical Device
Introduction
How To Determine Classification
Introduction
The Food and Drug Administration (FDA) has established classifications for
approximately 1,700 different generic types of devices and grouped them into
16 medical specialties referred to as panels. Each of these generic types
of devices is assigned to one of three regulatory classes based on the level
of control necessary to assure the safety and effectiveness of the device.
The three classes and the requirements which apply to them are:
Device Class and Regulatory Controls
1.Class I General Controls
With Exemptions
Without Exemptions
2.Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3.Class III General Controls and Premarket Approval
The class to which your device is assigned determines, among other things,
the type of premarketing submission/application required for FDA clearance
to market. If your device is classified as Class I or II, and if it is not
exempt, a 510k will be required for marketing. All devices classified as
exempt are subject to the limitations on exemptions. Limitations of device
exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892
. For Class III devices, a premarket approval application (PMA) will be
required unless your device is a preamendments device (on the market prior
to the passage of the medical device amendments in 1976, or substantially
equivalent to such a device) and PMA's have not been called for. In that
case, a 510k will be the route to market.
Device classification depends on the intended use of the device and also
upon indications for use. For example, a scalpel's intended use is to cut
tissue. A subset of intended use arises when a more specialized indication
is added in the device's labeling such as, "for making incisions in the
cornea". Indications for use can be found in the device's labeling, but may
also be conveyed orally during sale of the product. A discussion of the
meaning of intended use is contained in Premarket Notification Review
Program K86-33.
In addition, classification is risk based, that is, the risk the device
poses to the patient and/or the user is a major factor in the class it is
assigned. Class I includes devices with the lowest risk and Class III
includes those with the greatest risk.
As indicated above all classes of devices as subject to General Controls.
General Controls are the baseline requirements of the Food, Drug and
Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.
How to Determine Classification
To find the classification of your device, as well as whether any exemptions
may exist, you need to find the regulation number that is the
classification regulation for your device. There are two methods for
accomplishing this: go directly to the classification database4 and search
for a part of the device name, or, if you know the device panel5 (medical
specialty) to which your device belongs, go directly to the listing for that
panel and identify your device and the corresponding regulation. You may
make a choice now, or continue to read the background information below. If
you continue to read, you will have another chance to go to these
destinations.
If you already know the appropriate panel you can go directly to the CFR and
find the classification for your device by reading through the list of
classified devices, or if you're not sure, you can use the keyword directory
in the PRODUCT CODE CLASSIFICATION DATABASE6. In most cases this database
will identify the classification regulation in the CFR. You can also check
the classification regulations7 below for information on various products
and how they are regulated by CDRH.
Each classification panel in the CFR begins with a list of devices
classified in that panel. Each classified device has a 7-digit number
associated with it, e.g., 21 CFR 880.2920 8- Clinical Mercury Thermometer.
Once you find your device in the panel's beginning list, go to the section
indicated: in this example, 21 CFR 880.29209 . It describes the device and
says it is Class II. Similarly, in the Classification Database under "
thermometer", you'll see several entries for various types of thermometers.
The three letter product code, FLK in the database for Clinical Mercury
Thermometer, is also the classification number which is used on the Medical
Device Listing form.
Once you have identified the correct classification regulation go to What
are the Classification Panels10 below and click on the correct
classification regulation or go to the CFR Search page11. Some Class I
devices are exempt from the premarket notification and/or parts of the good
manufacturing practices regulations. Approximately 572 or 74% of the Class I
devices are exempt from the premarket notification process. These
exemptions are listed in the classification regulations of 21 CFR and also
has been collected together in the Medical Device Exemptions12 document. | s**********8
发帖数: 25265 | 2 本版以灌为主, 学术交流为辅. 额会贴一些相关的topic, 大家不受影响, 想看就看,
不想看跳过就好.
Premarket
into
【在 s**********8 的大作中提到】
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
: Device Classification
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s1 and Premarket Approvals2
: Classify Your Medical Device
: Introduction
: How To Determine Classification
: Introduction
: The Food and Drug Administration (FDA) has established classifications for
: approximately 1,700 different generic types of devices and grouped them into
| Y*********e
发帖数: 4847 | 3 怯怯的问，有中文的嘛
【在 s**********8 的大作中提到】
: 本版以灌为主, 学术交流为辅. 额会贴一些相关的topic, 大家不受影响, 想看就看,
: 不想看跳过就好.
:
: Premarket
: into
| s**********8
发帖数: 25265 | 4 ....凑和着看嘛.
【在 Y*********e 的大作中提到】
: 怯怯的问，有中文的嘛
| s**********8
发帖数: 25265 | 5 510K
Premarket Notification (510k)
Introduction
What is Substantial Equivalence
Who is Required to Submit a 510(k)
When a 510(k) is Required
When a 510(k) is not Required
Third Party Review Program
Introduction
Each person who wants to market in the U.S., a Class I, II, and III device
intended for human use, for which a Premarket Approval (PMA) is not required
, must submit a 510(k) to FDA unless the device is exempt from 510(k)
requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does
not exceed the limitations of exemptions in .9 of the device classification
regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k)
form, however, 21 CFR 8071 Subpart E describes requirements for a 510(k)
submission. Before marketing a device, each submitter must receive an order,
in the form of a letter, from FDA which finds the device to be
substantially equivalent (SE) and states that the device can be marketed in
the U.S. This order "clears" the device for commercial distribution.
A 510(k) is a premarket submission made to FDA to demonstrate that the
device to be marketed is at least as safe and effective, that is,
substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3))
that is not subject to PMA. Submitters must compare their device to one or
more similar legally marketed devices and make and support their substantial
equivalency claims. A legally marketed device, as described in 21 CFR 807.
92(a)(3), is a device that was legally marketed prior to May 28, 1976 (
preamendments device), for which a PMA is not required, or a device which
has been reclassified from Class III to Class II or I, or a device which has
been found SE through the 510(k) process. The legally marketed device(s)
to which equivalence is drawn is commonly known as the "predicate."
Although devices recently cleared under 510(k) are often selected as the
predicate to which equivalence is claimed, any legally marketed device may
be used as a predicate. Legally marketed also means that the predicate
cannot be one that is in violation of the Act.
Until the submitter receives an order declaring a device SE, the submitter
may not proceed to market the device. Once the device is determined to be SE
, it can then be marketed in the U.S. The SE determination is usually made
within 90 days and is made based on the information submitted by the
submitter.
Please note that FDA does not perform 510(k) pre-clearance facility
inspections. The submitter may market the device immediately after 510(k)
clearance is granted. The manufacturer should be prepared for an FDA quality
system (21 CFR 820) inspection at any time after 510(k) clearance.
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another
legally U.S. marketed device. Substantial equivalence means that the new
device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and the information submitted to
FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the
legally marketed device.
A claim of substantial equivalence does not mean the new and predicate
devices must be identical. Substantial equivalence is established with
respect to intended use, design, energy used or delivered, materials,
chemical composition, manufacturing process, performance, safety,
effectiveness, labeling, biocompatibility, standards, and other
characteristics, as applicable.
A device may not be marketed in the U.S. until the submitter receives a
letter declaring the device substantially equivalent. If FDA determines that
a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the de novo2 process
file a reclassification petition3, or
submit a premarket approval application (PMA).
Who is Required to Submit a 510(k)
The Act and the 510(k) regulation (21 CFR 807) do not specify who must apply
for a 510(k). Instead, they specify which actions, such as introducing a
device to the U.S. market, require a 510(k) submission.
The following four categories of parties must submit a 510(k) to the FDA:
1.Domestic manufacturers introducing a device to the U.S. market;
Finished device manufacturers must submit a 510(k) if they manufacture a
device according to their own specifications and market it in the U.S.
Accessories to finished devices that are sold to the end user are also
considered finished devices. However, manufacturers of device components are
not required to submit a 510(k) unless such components are promoted for
sale to an end user as replacement parts. Contract manufacturers, those
firms that manufacture devices under contract according to someone else’ s
specifications, are not required to submit a 510(k).
2.Specification developers introducing a device to the U.S. market;
A specification developer develops the specifications for a finished device,
but has the device manufactured under contract by another firm or entity.
The specification developer submits the 510(k), not the contract
manufacturer.
3.Repackers or relabelers who make labeling changes or whose operations
significantly affect the device.
Repackagers or relabelers may be required to submit a 510(k) if they
significantly change the labeling or otherwise affect any condition of the
device. Significant labeling changes may include modification of manuals,
such as adding a new intended use, deleting or adding warnings,
contraindications, etc. Operations, such as sterilization, could alter the
condition of the device. However, most repackagers or relabelers are not
required to submit a 510(k).
4.Foreign manufacturers/exporters or U.S. representatives of foreign
manufacturers/exporters introducing a device to the U.S. market.
Please note that all manufacturers (including specification developers) of
Class II and III devices and select Class I devices are required to follow
design controls (21 CFR 820.30) during the development of their device. The
holder of a 510(k) must have design control documentation available for FDA
review during a site inspection. In addition, any changes to the device
specifications or manufacturing processes must be made in accordance with
the Quality System regulation (21 CFR 820) and may be subject to a new 510(k
). Please see our guidance, "Deciding When to Submit a 510(k) for a Change
to an Existing Device4."
When a 510(k) is Required
A 510(k) is required when:
1.Introducing a device into commercial distribution (marketing) for the
first time. After May 28, 1976 (effective date of the Medical Device
Amendments to the Act), anyone who wants to sell a device in the U.S. is
required to make a 510(k) submission at least 90 days prior to offering the
device for sale, even though it may have been under development or clinical
investigation before that date. If your device was not marketed by your firm
before May 28, 1976, a 510(k) is required.
2.You propose a different intended use for a device which you already have
in commercial distribution. The 510(k) regulation (21 CFR 8075) specifically
requires a 510(k) submission for a major change or modification in intended
use. Intended use is indicated by claims made for a device in labeling or
advertising. Most, if not all changes in intended use will require a 510(k).
Please note that prescription use to over the counter use is a major change
in intended use and requires the submission of a new 510(k).
3.There is a change or modification of a legally marketed device and that
change could significantly affect its safety or effectiveness. The burden is
on the 510(k) holder to decide whether or not a modification could
significantly affect safety or effectiveness of the device. Any
modifications must be made in accordance with the Quality System regulation,
21 CFR 820, and recorded in the device master record and change control
records. It is recommended that the justification for submitting or not
submitting a new 510(k) be recorded in the change control records.
A new 510(k) submission is required for changes or modifications to an
existing device, where the modifications could significantly affect the
safety or effectiveness of the device or the device is to be marketed for a
new or different indication for use. See Is a new 510(k) required for a
modification to the device?6 for additional information.
When a 510(k) is Not Required
The following are examples of when a 510(k) is not required.
1.You sell unfinished devices to another firm for further processing or sell
components to be used in the assembling of devices by other firms. However,
if your components are to be sold directly to end users as replacement
parts, a 510(k) is required.
2.Your device is not being marketed or commercially distributed. You do not
need a 510(k) to develop, evaluate, or test a device. This includes clinical
evaluation. Please note that if you perform clinical trials with your
device, you are subject to the Investigational Device Exemption7 (IDE)
regulation (21 CFR 812).
3.You distribute another firm's domestically manufactured device. You may
place a label on the device, "Distributed by ABC Firm" or "Manufactured for
ABC Firm," (21 CFR 801.18) and sell it to end users without submission of a
510(k).
4.In most cases, if you are a repackager or a relabeler you are not required
to submit a 510(k) if the existing labeling or condition of the device is
not significantly changed. The labeling should be consistent with the
labeling submitted in the 510(k) with the same indications for use and
warnings and contraindications.
5.Your device was legally in commercial distribution before May 28, 1976 and
you have documentation to prove this. These devices are "grandfathered" and
have Preamendment Status9. You do not have to submit a 510(k) unless the
device has been significantly modified or there has been a change in its
intended use.
6.The device is made outside the U.S. and you are an importer of the foreign
made medical device. A 510(k) is not required if a 510(k) has been
submitted by the foreign manufacturer and received marketing clearance. Once
the foreign manufacturer has received 510(k) clearance for the device, the
foreign manufacturer may export his device to any U.S. importer.
7.Your device is exempted from 510(k) by regulation (21 CFR 862-892). That
is, certain Class I or II devices can be marketed for the first time without
having to submit a 510(k). A list of the Class I and II exempted devices
can be found on Medical Device Exemptions 510(k) and GMP Requirements10.
However, if the device exceeds the limitations of exemptions in .9 of the
device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9)
, such as the device has a new intended use or operates using a different
fundamental scientific technology than a legally marketed device in that
generic type of device, or the device is a reprocessed single-use device,
then a 510(k) must be submitted to market the new device.
Preamendment Devices
The term "preamendments device" refers to devices legally marketed in the U.
S. by a firm before May 28, 1976 and which have not been:
significantly changed or modified since then; and
for which a regulation requiring a PMA application has not been published by
FDA.
Devices meeting the above criteria are referred to as "grandfathered"
devices and do not require a 510(k). The device must have the same intended
use as that marketed before May 28, 1976. If the device is labeled for a new
intended use, then the device is considered a new device and a 510(k) must
be submitted to FDA for marketing clearance.
Please note that you must be the owner of the device on the market before
May 28, 1976, for the device to be grandfathered. If your device is similar
to a grandfathered device and marketed after May 28, 1976, then your device
does NOT meet the requirements of being grandfathered and you must submit a
510(k). In order for a firm to claim that it has a preamendments device, it
must demonstrate that its device was labeled, promoted, and distributed in
interstate commerce for a specific intended use and that intended use has
not changed. See Preamendment Status11 for information on documentation
requirements.
Third Party Review Program
The Center for Devices and Radiological Health (CDRH) has implemented a
Third Party Review Program. This program provides an option to manufacturers
of certain devices of submitting their 510(k) to private parties (
Recognized Third Parties) identified by FDA for review instead of submitting
directly to CDRH. For more information on the program, eligible devices and
a list of Recognized Third Parties go to Third Party Review Program
Information12 page.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H | Y*********e
发帖数: 4847 | 6 好的
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: ....凑和着看嘛.
| s**********8
发帖数: 25265 | 7 PMA
Premarket Approval (PMA)
Please note: As of October 1, 2002, FDA charges a fee for review of
Premarket Approvals1
Overview
When a PMA is Required
Devices Used in Blood Establishments
Data Requirements
References
Overview
Premarket approval (PMA) is the FDA process of scientific and regulatory
review to evaluate the safety and effectiveness of Class III medical devices
. Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of human health, or which
present a potential, unreasonable risk of illness or injury. Due to the
level of risk associated with Class III devices, FDA has determined that
general and special controls alone are insufficient to assure the safety and
effectiveness of class III devices. Therefore, these devices require a
premarket approval (PMA) application under section 515 of the FD&C Act in
order to obtain marketing clearance. Please note that some Class III
preamendment devices may require a Class III 510(k). See "Historical
Background2" for additional information.
PMA is the most stringent type of device marketing application required by
FDA. The applicant must receive FDA approval of its PMA application prior to
marketing the device. PMA approval is based on a determination by FDA that
the PMA contains sufficient valid scientific evidence to assure that the
device is safe and effective for its intended use(s). An approved PMA is, in
effect, a private license granting the applicant (or owner) permission to
market the device. The PMA owner, however, can authorize use of its data by
another.
The PMA applicant is usually the person who owns the rights, or otherwise
has authorized access, to the data and other information to be submitted in
support of FDA approval. This person may be an individual, partnership,
corporation, association, scientific or academic establishment, government
agency or organizational unit, or other legal entity. The applicant is often
the inventor/developer and ultimately the manufacturer.
FDA regulations provide 180 days to review the PMA and make a determination.
In reality, the review time is normally longer. Before approving or denying
a PMA, the appropriate FDA advisory committee may review the PMA at a
public meeting and provide FDA with the committee's recommendation on
whether FDA should approve the submission. After FDA notifies the applicant
that the PMA has been approved or denied, a notice is published on the
Internet (1) announcing the data on which the decision is based, and (2)
providing interested persons an opportunity to petition FDA within 30 days
for reconsideration of the decision.
The regulation governing premarket approval is located in Title 21 Code of
Federal Regulations (CFR) Part 8143, Premarket Approval. A class III device
that fails to meet PMA requirements is considered to be adulterated under
section 501(f) of the FD&C Act and cannot be marketed.
[back to top]
When a PMA is Required
PMA requirements apply to Class III devices, the most stringent regulatory
category for medical devices. Device product classifications can be found by
searching the Product Classification Database4. The database search
provides the name of the device, classification, and a link to the Code of
Federal Regulations (CFR), if any. The CFR provides the device type name,
identification of the device, and classification information.
A regulation number for Class III devices marketed prior to the 1976 Medical
Device Amendments is provided in the CFR. The CFR for these Class III
devices that require a PMA states that the device is Class III and will
provide an effective date of the requirement for PMA. If the regulation in
the CFR states that “No effective date has been established of the
requirement for premarket approval,” a Class III 510(k) should be submitted.
Please note that PMA devices often involve new concepts and many are not of
a type marketed prior to the Medical Device Amendments. Therefore, they do
not have a classification regulation in the CFR. In this case, the product
classification database will only cite the device type name and product code.
If it is unclear whether the unclassified device requires a PMA, use the
three letter product code to search the PMA database and the Premarket
Notification 510(k) database. These databases can be found by clicking on
the hypertext links at the top of the product classification database web
page. Enter only the three letter product code in the product code box. If
there are 510(k)’s cleared by FDA and the new device is substantially
equivalent to any of these cleared devices, then the applicant should submit
a 510(k).
Furthermore, a new type of device may not be found in the product
classification database. If the device is a high risk device (supports or
sustains human life, is of substantial importance in preventing impairment
of human health, or presents a potential, unreasonable risk of illness or
injury) and has been found to be not substantially equivalent (NSE) to a
Class I, II, or III [Class III requiring 510(k)] device, then the device
must have an approved PMA before marketing in the U.S. Some devices that are
found to be not substantially equivalent to a cleared Class I, II, or III (
not requiring PMA) device, may be eligible for the de novo process as a
Class I or Class II device. For additional information on the de novo
process, see “New section 513(f)(2) - Evaluation of Automatic Class III
Designation: Guidance for Industry and CDRH Staff5”.
[back to top]
Devices Used in Blood Establishments
The Center for Biologic, Evaluation, Research (CBER) has expertise in blood,
blood products, and cellular therapies as well as the integral association
of certain medical devices with these biological products. To utilize this
expertise marketing and investigational device submissions (Premarket
Notification, Premarket Approval, and Investigational Device Exemption) for
medical devices associated with the blood collection and processing
procedures as well as those associated with cellular therapies are reviewed
by CBER. Although these products are reviewed by CBER, the medical device
laws and regulations still apply. The list of medical devices reviewed by
CBER6 are available on the Internet.
In addition to CDRH guidance on Premarket Approval, specific medical device
guidance for devices reviewed by CBER7 is available at online or by
contacting:
Center for Biologics Evaluation and Research
Office of Communication, Training and Manufacturers Assistance (HFM-43)
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448 U.S.A.
Telephone Number: 301-827-2000 or 800-835-4709
Fax Number: 301-827-3843
[back to top]
Data Requirements
A Premarket Approval (PMA) application is a scientific, regulatory
documentation to FDA to demonstrate the safety and effectiveness of the
class III device. There are administrative elements of a PMA application,
but good science and scientific writing is a key to the approval of PMA
application. If a PMA application lacks elements listed in the
administrative checklist, FDA will refuse to file a PMA application and will
not proceed with the in-depth review of scientific and clinical data. If a
PMA application lacks valid clinical information and scientific analysis on
sound scientific reasoning, it will delay FDA?s review and approval. PMA
applications that are incomplete, inaccurate, inconsist, omit critical
information, and poorly organized have resulted in delays in approval or
denial of PMA applications. Manufacturers should perform a quality control
audit of a PMA application before sending it to FDA to assure that it is
scientifically sound and presented in a well organized format.
Technical Sections: The technical sections containing data and information
should allow FDA to determine whether to approve or disapprove the
application. These sections are usually divided into non-clinical laboratory
studies and clinical investigations.
Non-clinical Laboratory Studies' Section: Non-clinical laboratory studies'
section includes information on microbiology, toxicology, immunology,
biocompatibility, stress, wear, shelf life, and other laboratory or animal
tests. Non-clinical studies for safety evaluation must be conducted in
compliance with 21CFR Part 588 (Good Laboratory Practice for Nonclinical
Laboratory Studies).
Clinical Investigations' Section: Clinical investigations' section includes
study protocols, safety and effectiveness data, adverse reactions and
complications, device failures and replacements, patient information,
patient complaints, tabulations of data from all individual subjects,
results of statistical analyses, and any other information from the clinical
investigations. Any investigation conducted under an Investigational Device
Exemption (IDE) must be identified as such.
Like other scientific reports, FDA has observed problems with study designs,
study conduct, data analyses, presentations, and conclusions. Investigators
should always consult all applicable FDA guidance documents, industry
standards, and recommended practices. Numerous device-specific FDA guidance
documents that describe data requirements are available9. Study protocols
should include all applicable elements described in the device-specific
guidance documents.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm2007514.htm | s**********8
发帖数: 25265 | 8 exempt.
Class I / II Exemptions
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s1 and Premarket Approvals2
Introduction
Class I/II Devices Exempt from 510(k) and class I Devices Exempt from GMPs
Requirements for Class I/II Exempt Devices
Introduction
Most Class I devices and a few Class II devices are exempt from the
premarket notification [510(k)] requirements subject to the limitations on
exemptions. However, these devices are not exempt from other general
controls. All medical devices must be manufactured under a quality assurance
program, be suitable for the intended use, be adequately packaged and
properly labeled, and have establishment registration and device listing
forms on file with the FDA.
A few Class I devices are additionally exempt from the GMP requirements with
the exception of complaint files and general record keeping requirements.
Class I/II Devices Exempt from 510(k) and class I Devices Exempt from GMPs
Devices exempt from 510(k) are:
preamendment devices not significantly changed or modified; or
Class I/II devices specifically exempted by regulation.
For purposes of 510(k) decision-making, the term "preamendment device"
refers to devices legally marketed in the U.S. by a firm before May 28, 1976
and which have not been:
significantly changed or modified since then; and
for which a regulation requiring a PMA application has not been published by
FDA.
Devices meeting this description are referred to as "grandfathered" and do
not require a 510(k).
This website contains a listing of medical devices exempt3 from 510(k) and
Good Manufacturing Practices (GMP) compiled from Title 21 Code of Federal
Regulations (CFR) and recent federal register announcements on class I
exemptions and class II exemptions.
The Food, Drug and Cosmetic Act under section 513(d)(2)(A) authorizes FDA to
exempt certain generic types of Class I devices from the premarket
notification [510(k)] requirement. FDA has exempted over 800 generic types
of Class I devices and 60 class II devices from the premarket notification
requirement. The 510(k) exemption is with certain limitations, which are so
noted in ".9" of each chapter. It is important to confirm the exempt status
and any limitations that apply with 21 CFR Parts 862-8924 or the PRODUCT
CODE CLASSIFICATION DATABASE5 or subsequent FR announcements on class I
exemptions and class II exemptions.
If a manufacturer's device falls into a generic category of exempted Class I
devices as defined in 21 CFR Parts 862-892, a premarket notification
application and FDA clearance is not required before marketing the device in
the U.S.
How to Prepare A Traditional 510(k)6
Requirements for Class I/II Exempt Devices
Even though a 510(k) is not required, it is necessary to meet other
requirements for marketing. These include:
Registration and Listing7
Labeling8
GMP's
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O | s**********8
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Premarket
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: exempt.
: Class I / II Exemptions
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s1 and Premarket Approvals2
: Introduction
: Class I/II Devices Exempt from 510(k) and class I Devices Exempt from GMPs
: Requirements for Class I/II Exempt Devices
: Introduction
: Most Class I devices and a few Class II devices are exempt from the
: premarket notification [510(k)] requirements subject to the limitations on
| h******e
发帖数: 1811 | 10 替朋友问一个问题，搞MRI研究的想进入实践领域，有什么路？ | | | s**********8
发帖数: 25265 | 11 找imaging的公司吧
【在 h******e 的大作中提到】
: 替朋友问一个问题，搞MRI研究的想进入实践领域，有什么路？
| h******e
发帖数: 1811 | 12 怎么找？隔行如隔山，您给指条路？
【在 s**********8 的大作中提到】
: 找imaging的公司吧
| s**********8
发帖数: 25265 | 13 看看做imaging的公司有哪些啊. 额也不是太清楚. 额帮你问问.
【在 h******e 的大作中提到】
: 怎么找？隔行如隔山，您给指条路？
| l*****f
发帖数: 359 | 14 i'm still here!
working hard to learn!
【在 s**********8 的大作中提到】
: 人都boring跑光了.
:
: Premarket
| s**********8
发帖数: 25265 | 15 dont push too hard.
【在 l*****f 的大作中提到】
: i'm still here!
: working hard to learn!
| f******w
发帖数: 10267 | 16 好像在gardening版见过您？
【在 l*****f 的大作中提到】
: i'm still here!
: working hard to learn!
| l*****f
发帖数: 359 | 17 no worries, everything is under control
【在 s**********8 的大作中提到】
: dont push too hard.
| l*****f
发帖数: 359 | 18 correct! i like gardening, and medical device too
【在 f******w 的大作中提到】
: 好像在gardening版见过您？
| s**********8
发帖数: 25265 | 19 PMA 相当与 NDA for drug. new drug application.
IDE 相当与 IND for drug. investigational new drug application.
Premarket
into
【在 s**********8 的大作中提到】
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
: Device Classification
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s1 and Premarket Approvals2
: Classify Your Medical Device
: Introduction
: How To Determine Classification
: Introduction
: The Food and Drug Administration (FDA) has established classifications for
: approximately 1,700 different generic types of devices and grouped them into
| m*******o
发帖数: 4179 | 20
~~~~~~~~
really?
【在 s**********8 的大作中提到】
: 本版以灌为主, 学术交流为辅. 额会贴一些相关的topic, 大家不受影响, 想看就看,
: 不想看跳过就好.
:
: Premarket
: into
| | | s**********8
发帖数: 25265 | 21 lol.
【在 m*******o 的大作中提到】
:
: ~~~~~~~~
: really?
| l*****f
发帖数: 359 | 22 Mr. board master, is this board devoted to US MD only or include China?
【在 s**********8 的大作中提到】
: PMA 相当与 NDA for drug. new drug application.
: IDE 相当与 IND for drug. investigational new drug application.
:
: Premarket
: into
| s**********8
发帖数: 25265 | 23 same stuff bah. i have no experience for product approval in china. it's
good to share.
【在 l*****f 的大作中提到】
: Mr. board master, is this board devoted to US MD only or include China?
| l*****f
发帖数: 359 | 24 thanks for the prompt response. i appreciate it.
one more question, is the focus of this board on high-end MD only?
【在 s**********8 的大作中提到】
: same stuff bah. i have no experience for product approval in china. it's
: good to share.
| s**********8
发帖数: 25265 | 25 probably yes. but all related topics are welcome.
【在 l*****f 的大作中提到】
: thanks for the prompt response. i appreciate it.
: one more question, is the focus of this board on high-end MD only?
| l*****f
发帖数: 359 | 26 Roger that, Captain!
【在 s**********8 的大作中提到】
: probably yes. but all related topics are welcome.
| a********y
发帖数: 8573 | | s**********8
发帖数: 25265 | 28 but good money is with these boring stuff.
【在 a********y 的大作中提到】
: 天啊地啊
: 真的好boring啊
| w***u
发帖数: 17713 | 29 问那几个公司招人不，递简历看看。GE，Siemens，Philips，Toshiba。
【在 h******e 的大作中提到】
: 替朋友问一个问题，搞MRI研究的想进入实践领域，有什么路？
| s**********8
发帖数: 25265 | 30 cannon做不做?
【在 w***u 的大作中提到】
: 问那几个公司招人不，递简历看看。GE，Siemens，Philips，Toshiba。
| | | m*******o
发帖数: 4179 | 31 device exemptions是什么意思？
Premarket
【在 s**********8 的大作中提到】
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
: Device Classification
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s1 and Premarket Approvals2
: Classify Your Medical Device
: Introduction
: How To Determine Classification
: Introduction
: The Food and Drug Administration (FDA) has established classifications for
: approximately 1,700 different generic types of devices and grouped them into
| w***u
发帖数: 17713 | 32 好像不做，小一些的有varian，bruker，fonar。
【在 s**********8 的大作中提到】
: cannon做不做?
| s**********8
发帖数: 25265 | 33 好. 他的其它谱学仪器卖很多.
【在 w***u 的大作中提到】
: 好像不做，小一些的有varian，bruker，fonar。
| s**********8
发帖数: 25265 | 34 exempt from FDA regulations?
【在 m*******o 的大作中提到】
: device exemptions是什么意思？
:
: Premarket
| G*********o
发帖数: 49669 | 35 热
Premarket
into
【在 s**********8 的大作中提到】
: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
: Device Classification
: Please note: as of October 1, 2002, FDA charges fees for review of Premarket
: Notification 510(k)s1 and Premarket Approvals2
: Classify Your Medical Device
: Introduction
: How To Determine Classification
: Introduction
: The Food and Drug Administration (FDA) has established classifications for
: approximately 1,700 different generic types of devices and grouped them into
| w***u
发帖数: 17713 | 36 yeah, premarket notification application and FDA clearance before marketing
【在 s**********8 的大作中提到】
: exempt from FDA regulations?
| m********e
发帖数: 2059 | 37 must be very interesting, just kind of too long... | w***u
发帖数: 17713 | 38 Picker MRI 还是独立的啊？elscint都早卖掉了。 | f****w
发帖数: 431 | | k****i
发帖数: 1126 | 40 Actually, it is nice if someone could share their experience in China....
【在 s**********8 的大作中提到】
: same stuff bah. i have no experience for product approval in china. it's
: good to share.
|
|
