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.

Regulatory Sciences

June 28, 2021

45 Years of 510(k) Submissions: FDA Celebrates with Improvements to the Process

In late 2018, FDA announced changes to modernize and increase the efficiency of its 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the...

Read the Full Article
Agency Alerts General Regulatory

August 28, 2015

FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance

Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...

Read the Full Article
Agency Alerts General Regulatory

April 28, 2016

Consumer Fitness Tracking vs. Medical-Grade Devices: Fitbit’s Plan to Shift into a “Digital Health Company”

Founded in 2007 by James Park and Eric Friedman, Fitbit Inc. launched its first activity tracking device in 2009. The device was called the Fitbit Tracker and it worked by tracking a number of...

Read the Full Article