Jan

2006

Shelhigh Inc.

Recipient: Shelhigh Inc.
Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices

Date:12/14/05

Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive actions; failure of Device History File to demonstrate that the design was developed following the approved design plan; failure to maintain complaint files; and other violations

FDA District: New Jersey District Office

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Shelhigh Inc.

Amy Sellers

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