• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

Medical Device School's

Article Index

• 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.

• By FDA Regulation a 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(s)

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.