FEATURED PRODUCT: Interpretation of FDA's (QSR) With QSIT references
A
complete compendium to FDA's Quality System Regulation (QSR) with relative
references to FDA's Quality System Inspection Technique (QSIT). Now ONLY $99 (limited time)
Search This Site
Article Archives
$360
Million for Edwards Lifesciences Acquisitions
The largest producer of artificial heart valves, Edwards
Lifesciences Acquisitions, is looking to buy out heart medical device
manufacturers. The CEO - Michael Mussallem said - they prefer not be become
acquired, "it isn't part of our strategy".
$358K spent on lobbying in 3rd Quarter
In an attempt to create "patchwork of inconsistent and confusing guidance." AdvaMed has lobbied the government last quarter to keep from overturning a Supreme Court decision that protects manufactures from patient lawsuits.
FDA Considering Health IT Regulation
Last year as a result of Health IT problems - the FDA received notice that six people had died and another 44 were injured. The Agency believes however that the problem is more serious than they have visibility.
Smith & Nephew Takeover by US Rival?
Device Giants Search for Next Blockbuster Devices
The economy, a maturing market and tighter regulatory scrutiny are just some of the reasons prompting major medical device manufactures to go out shopping for acquisitions.
Nine Senators Address FDA’s Preliminary Reports
On December 21st, 2010 a letter representing 9 senators was sent to Commissioner Dr. Margaret Hamburg of the US FDA. The letter addressed the senator’s concerns that the preliminary reports issued by the FDA back on August 4, 2010 risked delaying effective medical devices from reaching intended patients.
Medical Devices and HIPAA
(Health Insurance Portability and Accountability Act) A Basic Introduction in
plain English
It became federal law on August 21, 1996 and will become
compliant mandatory on April 14th, 2005. This federal standard is stirring up a
big buzz across the nation as hospitals burn the midnight oil to meet
compliance.
FDA’s “Intended Use” and “Indications for Use”
Special attention should go into the construction of these
terms when applying to devices that are submitted to the FDA. However despite
sincere efforts a lot of manufacturers still get it wrong.
Sterility Assurance Level (SAL)
- A quick intro
Invasive Medical Devices are never fully “sterilized”,
however you can control the level of sterility based on your product’s bioburden
and sterilization.
The STED Initiative:
Bringing the Global Community Closer to Harmonization
The FDA is reminding device manufacturers of the Summary
Technical Document (STED) format submissions. Such formats are ideal for
manufacturers that end up submitting device documentation in multiple countries.
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS)
Software – There is no shortcut
The FDA’s issued a new document for dealing with
cybersecurity. They have a legitimate concern for worrying about threats
resulting from viruses and worms that can cause havoc on a network.
Risk Management Process and ISO 14971
As device manufacturers we have the responsibility of
ensuring that our products are safe before shipping them out the door. As such
we are required to have a risk management process in place and to have evidence
on hand that we have conducted a Hazard Analysis.
Biological Indicator Reduced Incubation Time (RIT) Study
Medical Device ethylene oxide sterilization is monitored
by the use of biological indicators (BIs) using Bacillus subtilis species. The
common “off the shelf” recommendation for incubation by most manufacturers is 7
days or more. However, there is a way to reduce the incubation time to as much
as 24 hours.
Medical Device Record
Retention
Keeping records is a matter of determining how long a
product will be in circulation. ISO 13485 as well as other standards and FDA
policy indicates that a record should be kept for the life of the product or if
short lived - at a minimum two to five years or more (depending on local laws).
Implementation of Risk Management for Medical Devices
ISO 14971 is a “Risk Management” standard. It covers not
only the risk determination activities but encompasses the whole application of
risk to overall activities.
Advertising
Medical Devices In the US
Under Federal Food, Drug, And Cosmetic Act (FFDCA) Medical
Devices are to be sold only for FDA cleared (510k) or approved (PMA) Intended
Uses. If a device is promoted for an indication other than what was approved
they risk being charged with adulteration or misbranding. This enforcement
policy also applies to devices that are sold with false or misleading claims,
and counterfeits.
Component or Accessory to a Medical Device is a Medical Device
This can be a difficult part of the regulation to fully
grasp and apply. Mainly because there are a lot of factors that add to the
complexity of the issue.
A
Summary of the European Commission’s EVALUATION OF CLINICAL DATA: A GUIDE FOR
MANUFACTURERS AND NOTIFIED BODIES
As part of the conformity assessment procedures required
by 90/385/EEC (AIMD) [1] and 93/42/EEC (MDD) it is the manufacturer’s
responsibility to review and analyze clinical data. Clinical data is often
required to demonstrate safety and effectiveness (performance) of a medical
device.
Preparing for Your FDA
Inspection
If you sell medical devices in the USA, the FDA is coming.
Whether you are located in the United States or in Europe or elsewhere abroad –
you must be prepared. Making some last minute preparations could mean the
difference between a good audit and one with a multitude of 483s.
How to Respond to an FDA Warning Letter or 483
The FDA writes warning letters in response to violations
of the Federal FD&C Act, or other acts. Failure to take prompt appropriative,
corrective/preventive action can result in enforcement action without further
notice.
Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices
The FDA recently updated their guidance document for the
content of premarket submissions for software contained in medical devices. The
changes were substantial in content.
Implementing Human Factors
Engineering (HFE) Into Medical Device Design
Human Factors Engineering is applying science to improve
the user-device interface. Consideration of the interaction between user and
device is essential in the design phase of the development process.
Benefit's of Third Party
Review of Low to Medium Risk 510(k)s
On August 1st, 1996 FDA launched a pilot program allowing
voluntary Third Party Review of selected devices. The program allowed the FDA to
concentrate on higher risk devices, while approved Third Party Reviewers handled
low to medium risk products.
Conducting
Clinical Investigations In Canada
Clinical Investigations pathway in Canada is determined by
the classification of your device. Obviously the higher the classification the
more you will require and the more safety precautions you will need for the
investigation.
Site Map »
Media package available for advertisers looking to advertise on this site.