CDRH – Recognized Standards - Performance Validation

As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards. Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Excerpt from List 051:

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency’s searchable database. FDA is using the term “Recognition List Number: 051” to identify the current modifications.

In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 051.

Alex Wegner

Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.

Schedule with Alex Wegner