Regular updates should require for CER
as part of post market surveillance and vigilance activity

Based on the data they need to conclude in CER

Appraising the quality and significance

Manufacturer identify the data from
literature, experience, quality or any combination of three

Clinical evaluation
reports has 3 steps

This document
concludes clinical evaluation of medical devices. It consists of data which is
collected from either investigation of device or from results of those device. The
essential step is to obtain CE marking for every devices, for which to sell or

Clinical evaluation report

Harvest large volumes of bone marrow from the iliac
crest or the proximal tibia, quickly and easily insert the iliac crest during
the orthopedic trauma surgery, the mass of the attached handles increases the
momentum and facilitates insertion of the OTA into the desired location for
bone marrow harvest, aspirate bone marrow into separate reservoir, use the filtration
mechanism of the reservoir to filter marrow stromal cells and simultaneously
immerse bone graft extenders in actively aspirated marrow, optimize marrow to
bone graft substitute ratio

The OTA Outologous Trephine-Aspirator enables
the surgeon to harvest substantial quantities of bone marrow using a minimally
invasive technique

Product 3: with increasing interest in bone marrow
aspiration, the product use to obtain such graft should be safe, simple
efficient, easy to use and employ the process that gently aspirates the desired
amount of bone marrow   

Product 2: The bone saver allows the surgeon to quickly
harvest a closed fracture hematoma and small bone fragments during open
reductions internal fixations of long bones requiring bone grafting

Product 1: the bone tool allows surgeon to
harvest several cores  of cancellous
bone  and substancial quality of marrow along
with small fragments of bone generated during harvest process the vacuum
ensures that structural integrity of cancellous core is substantially
maintained while facilitating its removal from illium, once the harvest is
completed, the marrow elements are mixed up with harvested cancellous bone,
this mixture of cancellous bone and bone marrow is then implemented into the
host site. The syringe action of the bone tamp/plunger further allow the
surgeon to additional marrow from the harvest site

6.       Use
of real world evidence for medical devices

5.       FDA
issues long awaited 3D printing guidance for medical devices

4.       FDA
released guidance on software as medical device for consultation

3.       Mobile
apps for which FDA intends to exercise enforcements

2.       Draft
guidance for industry and food and drug administration

1.       Display
devices for diagnostic radiology

5 guidance documents for
medical devices released by U.S FDA in the year 2016.

Clinical investigations

Non clinical laboratory studies

Technical sections

The requirement for data is

Premarket approval is the FDA
process to evaluate the safe and effectiveness of class 3 medical devices and
class 3 devices are high risk, because of high level risk associated, FDA has
some controls based on registration, listing, and quality system regulation. Premarket
approval is apply to the class 3 devices, and these device can be found by
using FDA classification database. These database includes name, classification
and also link to the code of federal regulations.

This submission number requires
when marketing for first time, if there is any change/modification in marketed
device and could affect safety and cost effectiveness. When device is not
marketed and commercially distributed, device is outside the United States,
devices are lawfully marketed in U.S, if we are repackage or relabelers, the
submission is not required The fees of the device is reviewed by FDA’s center,
depending in product review, including submission number, premarketing
approval, product development protocol and certain supplements.

Foreign manufacturers

Repackages and relabelers

Specification developers

Domestic manufacturer

Requirement for submission for

Substantial equivalence is
required, it means the device is as least and cost effective as predicted. Substantial
equivalence is established with respect to use, design, chemical composition,
process, performance, safety, cost effective, biocompatibility. If device is
not substantially equivalent, the FDA determines and that applicant may have to
resubmit premarket submission number with new data, request through de novo process
(class 1 and class 2), File petition and also submit premarket approval

Each firm that wants to market a
Class I, II, or III medical device in the U.S., for which a Premarket Approval
is not required, must submit a 510(k) to FDA unless the device is exempt from
510(k) requirements of the FDCA and does not exceed the limitations of
exemptions noted in chapters that end in .9 of the device classification
regulations like 21 CFR 862.9. Before marketing the device, each submitter
needs must receive an order in form of letter from the Food and Drug Administration

Owners and operators involved in
production and distribution of medical device are requires to register annually
with Food and Drug Administration, this process known as establishment
registration. The company which produced their devices have to make list that
are made and this list include, manufacturers, contract manufactures , contract
sterilizers, repackages and relabelers, developers, remanufacturer. Owner or
operator should provide the Food and Drug Administration premarket submission
number 510(k) before being marketed in United States

These devices are classified into
Class 1, class 2 and class 3, and this defines the requirement for regulatory for
normal device type. Class 1 devices can be sold without preapproval, class 2
devices need approval from FDA before selling in United States, and this
application is referred to as ‘510(k)’ depends on the Food, drug and cosmetic
act known as ‘premarket notification’. Class 3 devices are most expensive and
also requires trials known as ‘premarket approval’ before selling.

United States regulates medical
devices uses classification based on the patient risk from medical device.

Medical device regulation in the
United States?


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