FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the FD&C Act permitting the exemption of a device from the requirement to submit a 510(k).
[6/21/2018] The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation. The FDA believes that in better addressing these issues in the future, the agency can advance principles that can promote a more efficient pathway for the development of biosimilar products.
The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.
Guidance Document updates on the FDA website
CDER & CBER
CDER & CDRH
CDER & CBER
Posted in Drug and Device Corner.