On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days. The grace period starts when Device Identified (DI) information is first entered …
On December 18, 2018, FDA issued a final guidance document on the Breakthrough Devices Program created by the 21st Century Cures Act. The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.” …
On November 5, 2018, FDA issued its latest UDI policy “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” deferring enforcement of direct marking deadlines. The new guidance, effective immediately, supersedes the guidance issued in …
Last month, FDA announced a plan for revamping the 510(k) Third Party Review Program (the “Program”), which was outlined in a publication, Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (the “Plan”). One element of the Plan includes the issuance of a draft guidance, …
FDA recently issued its final rule for the Voluntary Malfunction Summary Program, which permits manufacturers to report certain device malfunctions for low-risk products in summary form on a quarterly basis, as an alternative to the Medical Device Reporting (MDR) requirements set forth in section 519 …
Rather than rolling out the red carpet, DOJ has been highlighting with little fanfare a policy that could prove to be a powerful negotiating tool for companies in the government’s crosshairs. First announced by Deputy Attorney General Rod Rosenstein here, and later reinforced by Acting …
Earlier this month, FDA issued a draft guidance: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. This draft guidance would expand use of the Abbreviated 510(k) pathway as follows: “The intent of the guidance is to describe an optional pathway for …
On January 30, 2018, FDA issued revised guidance documents: Refuse to Accept Policy for 510(k)s and PMAs (here and here). These revised guidances may have gone unnoticed by many as there was no federal register notice announcing or discussing the revisions from the policy in …
Last week, the U.S. District Court for the District of Columbia dismissed a lawsuit filed by the Environmental Working Group (EWG) and Women’s Voices for Earth (WVE) against the Food and Drug Administration (FDA) and the Commissioner of the FDA. The facts of this case …
The saga continues in United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), a False Claims Act case alleging that Gilead concealed information from FDA regarding the contamination of certain drugs, leading to false claims being paid by the …
We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding: This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is …
On December 5, 2017, FDA issued a final guidance: Technical Considerations for Additive Manufactured Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Additive Manufacturing (AM) is “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to …
On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a …
On July 11, 2017, in the Federal Register, FDA published the finalized list of Class II devices that are now exempt from the 510(k) requirements. This list is identical in substance to the proposed list published on March 14, 2017 (see our prior post here). …
Since the Supreme Court’s decision in United Health Services v. United States ex rel. Escobar, we have seen a narrowing of situations in which courts will find liability under the False Claims Act (“FCA”). A district court in Pennsylvania provided yet another example of this …
