FDA Practice

 

 

 

    

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FDA medical devices

 

The U.S. Food and Drug Administration (FDA) watches over a variety of medical devices ranging from latex gloves (Class I) to artificial hearts (Class III).  The agency screens medical devices to ensure that they are reasonably safe and effective, prior to allowing them to be sold or used by the public.  It does this by a formal approval review and registration process in which device safety and effectiveness are documented.

 

The documentation required to show baseline safety and effectiveness of a medical device depends on its intended use, indicated use and risk posed to the user. Most low risk Class I devices are exempt from pre-market notification; most Class II devices require pre-market notification; and most high risk Class III devices require full documentation and pre-market approval. All medical devices are subject to listing, labeling, quality and reporting obligations.

 

Firms and individuals who manufacture, repackage, re-label and/or import medical devices sold in the United States are subject to certain disclosure, reporting and control obligations established by the Center for Devices and Radiological Health (CDRH).  In addition, the CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens, cell phones and color TV sets.

 

Minimum compliance obligations of medical device establishments:

  establishment registration

  medical device listing

  pre-market notification, unless exempt, or pre-market approval

  quality system regulation

  labeling

  reporting (adverse user reactions, abnormal test results, device malfunctions)

 

 

Our practice before the U.S. Food and Drug Administration:

  medical device classification, listing and labeling

  establishment registration and reporting

  advising device manufacturers regarding compliance with FDA regulations

  inspections, recalls and proposals to ban or withdraw approval

  510(k) pre-market notifications

  investigational device exemptions and pre-IDE submissions

  pre-market approval applications and reclassification petitions

  de novo review submissions and product designation requests

 

Contact the lawyers at Griggs Bergen LLP to schedule a confidential consultation. 

                                      

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X-ray image of an artificial hip joint prosthesis, classified by the FDA as a Class III medical device.

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