2020-03-11

医药类股票-510K VS PMA

DETERMINING WHETHER YOU SHOULD SUBMIT A 510K VS PMA FOR YOUR MEDICAL DEVICE BEGINS WITH AN UNDERSTANDING OF HOW YOUR MEDICAL DEVICE IS CLASSIFIED AND WHAT OTHER DEVICES IT MIGHT BE SIMILAR TO.
If you are planning to manufacture or distribute a medical device within the United States of America, the FDA requires (in most cases) that you complete either a 510k submission or obtain premarket approval for your medical device. Whether your device requires premarket approval, and what kind of approval it needs, depends on the device classification, which corresponds to device risk. As such, medical device manufacturers must complete the following steps from the outset of the product development process:

Use FDA guidelines to determine device classification.
Once classified, determine whether the device requires premarket approval and whether a 510k submission or a PMA is required.
Submit the required documentation to the FDA to get approval for the device.
DEVICE CLASSES AND PREMARKET REQUIREMENTS
The FDA divides medical devices into three classes that correspond generally to their risk profile:

Class I: These devices are simple, with minimal risk to the user. They are subject to the general regulatory controls of medical devices and typically do not require any premarket submissions.

Class II: Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification (510k submission) before they can be legally marketed. Items like pregnancy testing kits, intravenous kits, sutures, and powered wheelchairs could fall into this category. These devices are important for health care, but a malfunction would be unlikely to cause critical harm to a patient.

Class III: Class three devices are typically either implanted medical devices or those that sustain life, like an implantable pacemaker, blood vessel stents, or other implanted device. Devices in this class are seen as the highest risk for patients, as any problems with the device could lead to significant adverse outcomes for the patients. Class III devices require a PMA submission before being marketed in the USA.

510K VS PMA - WHAT'S THE DIFFERENCE?
So far, we've learned that Class II medical devices require a 510k submission (premarket notification), while Class III devices require a PMA (premarket approval), but what is the difference between these two processes?

The purpose of a 510k submission is to provide the FDA with documented evidence which proves that your medical device is substantially equivalent to a predicate device, one that has already been approved for marketing by the FDA. The FDA processes 510k submissions in 30-90 days. Proving substantial equivalency means that you'll need to compare and contrast your device with the predicate device, and while laboratory testing is a typical requirement, human testing is usually not needed for 510k submissions. Information from your documented Design Controls process, such as intended use, indications for use, design inputs (learn how to define them here), and design verification are all useful inputs for your 510k submission.

A PMA is more in-depth than a 510k - it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing. The standards here are much higher than for 510k submissions, and the FDA has just 180 days to accept or reject the application.



GREENLIGHT GURU QMS SUPPORTS 510K SUBMISSIONS AND PMA APPLICATIONS
Whether you are building a new and revolutionary high-risk device that requires a PMA, or you're sourcing information from your design controls to prove substantial equivalency to another product as part of a 510k submission, greenlight QMS securely organizes all of the required information, making it simple to create and revise your regulatory submissions as you develop your product.

An organized and secure single source of truth for your medical device company is instrumental in expediting compliance with FDA regulations and getting your product to market as quickly as possible.
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2020-03-10

6 rsync Examples to Exclude Multiple Files and Directories using exclude-from

y RAMESH NATARAJAN on JANUARY 25, 2011
Rsync is very powerful tool to take backups, or sync files and directories between two different locations (or servers).
You know this already, as we presented you with practical examples on rsync earlier.
In a typical backup situation, you might want to exclude one or more files (or directories) from the backup. You might also want to exclude a specific file type from rsync.
This article explains how to ignore multiple files and/or directories during rsync with examples.
First, create a sample directory structure as shown below (with some empty files) that can be used for testing purpose.
$ cd ~
$ mkdir -p source/dir1/dir2
$ mkdir -p source/dir3
$ touch source/file1.txt
$ touch source/file2.txt
$ touch source/dir1/dir2/file3.txt
$ touch source/dir3/file4.txt
The above command will create a source directory (under your home directory) with the following structure.
source
- file1.txt
- file2.txt
- dir1
  - dir2
    - file3.txt
- dir3
  - file4.txt

1. Exclude a specific directory

If you don’t want to sync the dir1 (including all it’s subdirectories) from the source to the destination folder, use the rsync –exclude option as shown below.
$ rm -rf destination

$ rsync -avz --exclude 'dir1' source/ destination/
building file list ... done
created directory dest
./
file1.txt
file2.txt
dir3/
dir3/file4.txt
Verify to make sure dir1 is not copied from source directory to destination directory.
$ find destination
destination
destination/file2.txt
destination/file1.txt
destination/dir3
destination/dir3/file4.txt

2. Exclude multiple directories that matches a pattern

The following example will exclude any directory (or subdirectories) under source/ that matches the pattern “dir*”
$ rm -rf destination

$ rsync -avz --exclude 'dir*' source/ destination/
building file list ... done
created directory destination
./
file1.txt
file2.txt
Verify the destination directory to make sure it didn’t copy any directories that has the keyword “dir” in it.
$ find destination
destination
destination/file2.txt
destination/file1.txt

3. Exclude a specific file

To exclude a specific file, use the relative path of the file in the exclude option as shown below.
$ rm -rf destination

$ rsync -avz --exclude 'dir1/dir2/file3.txt' source/ destination/
building file list ... done
created directory destination
./
file1.txt
file2.txt
dir1/
dir1/dir2/
dir3/
dir3/file4.txt
Verify the destination directory to make sure it didn’t copy the specific file ( dir1/dir2/file3.txt in this example).
$ find destination
destination
destination/file2.txt
destination/file1.txt
destination/dir1
destination/dir1/dir2
destination/dir3
destination/dir3/file4.txt

4. Exclude path is always relative

If you are not careful, you might make this mistake.
In the following example, the exclude option seems to have a full path (i.e /dir1/dir2/file3.txt). But, from rsync point of view, exclude path is always relative, and it will be treated as dir1/dir2/file3.txt. In the example below, rsync will look for dir1 under source directory (and not under / root directory).
$ rsync -avz --exclude '/dir1/dir2/file3.txt' source/ destination/
So, the above command is exactly same as the following. Just to avoid confusion (and to make it easy to read), don’t give / in front of the exclude path.
$ rsync -avz --exclude 'dir1/dir2/file3.txt' source/ destination/

5. Exclude a specific file type

To exclude a specific file type that has a specific extension, use the appropriate pattern. For example, to exclude all the files that contains .txt as extension, do the following.
$ rsync -avz --exclude '*.txt' source/ destination/
building file list ... done
created directory destination
./
dir1/
dir1/dir2/
dir3/
Verify the destination directory to make sure it didn’t copy the *.txt files.
$ find destination
destination
destination/dir1
destination/dir1/dir2
destination/dir3
Note: The above is very helpful, when you want to backup your home directory, but exclude all those huge image and video files that has a specific file extension.

6. Exclude multiple files and directories at the same time

When you want to exclude multiple files and directories, you can always specify multiple rsync exclude options in the command line as shown below.
$ rsync -avz --exclude file1.txt --exclude dir3/file4.txt source/ destination/
Wait. What if I had tons of files that I want to exclude from rsync?
I can’t keep adding them in the command line using multiple –exclude, which is hard to read, and hard to re-use the rsync command for later.
So, the better way is to use rsync –exclude-from option as shown below, where you can list all the files (and directories) you want to exclude in a file.
First, create a text file with a list of all the files and directories you don’t want to backup. This is the list of files and directories you want to exclude from the rsync.
$ vim exclude-list.txt
file1.txt
dir3/file4.txt
Next, execute the rsync using –exclude-from option with the exclude-list.txt as shown below.
$ rm -rf destination

$ rsync -avz --exclude-from 'exclude-list.txt' source/ destination/
building file list ... done
created directory destination
./
file2.txt
dir1/
dir1/dir2/
dir1/dir2/file3.txt
dir3/
Verify the desitination directory to make sure the files and directories listed in the exclude-list.txt file is not backed-up.
$ find destination
destination
destination/file2.txt
destination/dir1
destination/dir1/dir2
destination/dir1/dir2/file3.txt
destination/dir3
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2020-03-05

Which programming language has the easiest to read programming documentation?

Which programming language has the easiest to read programming documentation?
Mario Galindo Queralt, Ph.D.- AI Researcher - C++ Programmer for pleasure
Updated Nov 22
C++ has a huge, easy to read, online free programming documentation.
In the following, I am collecting a list of free material of C++ to help everyone. I spect to upgrade it regularly:
Standard references:
Guidelines:
Articles:
Tutorials and lessons:
General information:
Videos (Tutorials):
Free C++ books:
Not free books but the best:
Free compilers:
Online compilers:
Free IDEs:
Not Free IDEs:
Debugging tools:
Free libraries:
Algorithms implemented in C++:
Source code browser:
  • http://code.woboq.org Online source code browser for gcc, clang, LLVM, Qt, GLibc, Boost, Linux and others.
I'm sure I've forgotten to include several important places. Please, if you think I should mention other places, let me know in a comment.
Regards.
Note: Maybe you can bookmark this answer for future reference. Also, it would be valuable for others if you share it.
If this answer was helpful, Please UPVOTE and consider following me-Mario Galindo Queralt.
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How to Add a Directory to PATH in Linux

 https://linuxize.com/post/how-to-add-directory-to-path-in-linux/ When you type a command on the command line, you’re basically telling the ...