FDA Modifies Certain Medical Device Requirements

April 4, 2016

On Monday, April 4th, FDA announced a publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 041,” which contains modifications to the list of standards FDA recognizes for use in premarket reviews. In its announcement, FDA stated that the publication “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”

Included in the modifications are the addition, withdrawal, correction, and revision of certain consensus standards that will be recognized for use in premarket submissions and other regulatory requirements for medical devices. These changes will be added to the list of FDA Recognized Consensus Standards, and include the following:

  • The withdrawal of standards and their replacement by others, if applicable.
  • The correction of errors made by FDA in listing previously recognized standards.
  • The changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In addition, FDA lists modifications that are being made involving the addition of standards not previously recognized by the Agency, and provides a listing of new entries and consensus standards that are being added.

FDA invites interested parties to submit comments at any time, and states that these modifications are effective immediately. For a full list of FDA Recognized Consensus Standards, visit the FDA’s website.

Do you manufacture a medical device or other FDA-regulated product? We can help ensure that your product is compliant with all of the Agency’s requirements. To learn more about our services and how we can help you, contact us today.

Qualification & Validation Life Science Consulting

April 4, 2016

Quick Guide: Coordinating a Laboratory Move

Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...

Read More

April 4, 2016

Medical Information Outsourcing Models

In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...

Read More
Life Science Consulting

April 4, 2016

Improve Quality Using an Organizational Maturity Model

If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...

Read More