In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities entitled, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry,” (the Revised Draft Guidance). FDA released this Revised Draft Guidance to describe FDA’s current thinking on what FDA has described as…

Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2018” on Wednesday, January 16, 2019 at 12 p.m. ET. Each year since 2007, Reed Smith’s Drug and Device Law blog contributors have compiled and posted lists of the 10 best and 10 worst drug and medical device court decisions for that year. Starting…

On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective safety and performance criteria, at least for certain well-known devices. This revised approach comes at a time when advances in…

The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in our recent client alert, the OIG determined that while the FDA has started to include cybersecurity concerns in its review process, the FDA should take steps to ensure their cybersecurity review is systematic and…

The Office of Inspector General (OIG) recently gave the green-light on a medical device manufacturer’s proposed warranty program, wherein the company would provide a refund to the hospital at which a patient underwent joint replacement surgery using the company’s knee or hip implant and related products, if the patient was readmitted within 90 days because of a surgical site infection or need for implant replacement surgery. Advisory Opinion No. 18-10 concluded that although the suggested…

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG describes this request for information (RFI) as part of HHS’s endeavor “to transform the health care system into one that better pays for value.” The RFI looks to identify ways to amend or add…

The United Kingdom (UK) is scheduled to leave the European Union on 29 March 2019. Certain key aspects of the Brexit deal now seem to have been agreed upon, including a 21 month “transitional period” after the UK’s exit, but the full agreement has not yet been finalized and there is currently a risk of no deal being reached. The UK pharmaceuticals sector is a key industry seeking clarity, particularly on the following important areas:…