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MedicalDevice版 - How to market a medical device, by FDA
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Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H
How to Market Your Device
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Introduction
Three Steps to Obtaining Marketing Clearance from CDRH
Classify Your Device
Selecting the Appropriate Marketing Application
Other Requirements Besides Marketing Clearance
In Vitro Diagnostic Devices
Introduction
One of the most difficult aspects of getting a medical device to market is
KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what
order they are to be taken. Essentially, medical devices are subject to the
general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are
contained in the final procedural regulations in Title 21 Code of Federal
Regulations Part 800-1200 (21 CFR Parts 800 - 1299). These controls are the
baseline requirements that apply to all medical devices necessary for
marketing, proper labeling and monitoring its performance once the device is
on the market.
Three Steps to Obtaining Marketing Clearance from CDRH
STEP ONE in the marketing process is to make absolutely sure that the
product that you wish to market is a medical device, that is, does it meet
the definition of a medical device in section 201(h) of the FD&C Act. For
example, the product may be a drug or biological product that is regulated
by a component in the FDA other than the Center for Devices and Radiological
Health (CDRH) and for which there are different provisions in the FD&C Act.
Or your product may be a medical device and is also an electronic radiation
emitting product with additional requirements.
Classify Your Device
STEP TWO is to determine how FDA may classify your device - which one of the
three classes the device may fall into. Unless exempt, FDA will classify
your device. Classification identifies the level of regulatory control that
is necessary to assure the safety and effectiveness of a medical device.
Most importantly, the classification of the device will identify, unless
exempt, the marketing process (either premarket notification [510(k)] or
premarket approval (PMA)) the manufacturer must complete in order to obtain
FDA clearance/approval for marketing.
Selecting the Appropriate Marketing Application
STEP THREE is the development of data and/or information necessary to submit
a marketing application, and to obtain FDA clearance to market. For some [
510(k)] submissions and most PMA applications, clinical performance data is
required to obtain clearance to market. In these cases, conduct of the trial
must be done in accord with FDA's Investigational Device Exemption (IDE)
regulation, in additon to marketing clearance.
510k Information
PMA Information
Exempt Device Information
Other Requirements Besides Marketing Clearance
Premarket Requirements: Labeling, Registration, Listing
Before marketing clearance is obtained the manufacturer must assure that the
device is properly labeled in accordance with FDA's labeling regulations.
Once clearance for marketing is obtained, the manufacturer must register
their establishment and list the type of device they plan to market with the
FDA. All registration and listing information (Annual, Initial or Updates)
are to be submitted electronically unless FDA grants you a waiver.
Postmarket Requirements: Quality System, Medical Device Reporting
Once on the market, there are postmarket surveillance controls with which a
manufacturer must comply. These requirements include the Quality Systems (QS
) (also known as Good Manufacturing Practices, GMPs) and Medical Device
Reporting (MDR) regulations. The QS regulation is a quality assurance
requirement that covers the design, packaging, labeling and manufacturing of
a medical device. The MDR regulation is an adverse event reporting program.
In Vitro Diagnostic Devices
In vitro diagnostics (IVD)
IVDs are medical devices that analyze human body fluids, such as blood or
urine, to provide information for the diagnosis, prevention, or treatment of
a disease. The device classification for these devices can be found under
21 CFR 862, 21 CFR 864, and 21 CFR 866.
Clinical Laboratory Improvement Act (CLIA) of 1988
In addition to FDA regulation under the Food, Drug, and Cosmetic Act, in
vitro diagnostic (IVD) devices are also subject to the Clinical Laboratory
Improvement Amendments (CLIA) of 1988. This law established quality
standards for laboratory testing and an accreditation program for clinical
laboratories.
The requirements that apply vary according to the technical complexity in
the testing process and risk of harm in reporting erroneous results. The
regulations established three categories of testing on the basis of the
complexity of the testing methodology: a) waived tests, b) tests of moderate
complexity, and c) tests of high complexity. Laboratories performing
moderate- or high-complexity testing or both must meet requirements for
proficiency testing, patient test management, quality control, quality
assurance, and personnel. These specific requirements do not apply to tests
in the waived category.
In January 2000 the categorization of commercially marketed in vitro
diagnostic tests under CLIA was tranferred from the Center for Disease
Control (CDC) to FDA. CDRH's Office of Device Evaluation/Division of
Clinical Laboratory Devices (DCLD) will determine the appropriate complexity
categories for clinical laboratory devices as they evaluate premarket
submissions. Waived products, devices exempt from premarket notification,
and devices under premarket review by other FDA centers also will be
processed by DCLD. Responsibilities currently assigned to CDC, including
review of test systems, assays, or examinations not commercially marketed as
IVD products, will remain with CDC.
Product Complexity Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search
Labeling
Specific labeling requirements for IVDs can be found under 21 CFR 809.
Additional guidance can be found under "Device Advice Labeling Requirements
for In Vitro Diagnostic Devices."
Links
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
FDA's CLIA homepage
Product Complexity Database
Center for Disease Control , Morbidity and Mortality Weekly Report (MMWR),
Regulations for Implementing the Clinical Laboratory Improvement Amendments
of 1988: A Summary, February 28, 1992 / 41(RR-2);001
CLIA Waivers: List of Tests Waived by FDA
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