Tag Archives: medical devices

FDA Finalizes Two Guidance Documents Regarding Regenerative Medicine Therapies

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.

Read more

Read full article

FDA Embraces Role in Managing Medical Device Cybersecurity Risk by Issuing New Guidance

On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.  This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions.  This guidance comes at a critical time as the healthcare industry is a prime target for hackers.  On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device vulnerabilities.  Further, a report by KLAS Research in collaboration with the College of Healthcare Information Management Executives (CHIME) found that 18 percent of healthcare organizations reported that their medical devices were hit by malware or ransomware.  Many experts are also projecting that more cyber-attackers will target devices in 2019.

Read more

Read full article

Not Business as Usual: The Government Shutdown’s Impact at FDA

The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb, M.D., Commissioner of the FDA (“Dr. Gottlieb”), has tweeted frequent updates regarding FDA operations. As he explained, FDA officials initially consulted with public health experts and other senior leaders regarding which FDA activities address threats to human life and safety and, thus, should continue during the shutdown.

Read more

Read full article

FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices

On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability… [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]

Read more

Read full article

Year-End Reviews Highlight Antitrust Enforcement in, And Guidance Relevant to, Health Care Industry; Aggressive Enforcement is Likely to Continue in 2017

The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“Antitrust Division”) released their respective year-end reviews highlighted by aggressive enforcement in the health care industry. The FTC, in particular, indicated that 47% of its enforcement actions during calendar year 2016 took place in the health care industry (including pharmaceuticals and medical devices). Of note were successful challenges to hospital mergers in Pennsylvania (Penn State Hershey Medical Center and Pinnacle Health System), and Illinois (Advocate Health Care Network and North Shore University Health System). In both actions, the FTC was able to convince the court that the merger would likely substantially lessen competition for the provision of general acute-care hospital services in relevant areas in violation of section 7 of the Clayton Act. See FTC v. Penn State Hershey Med. Center, 838 F. 3d 327 (3d Cir. 2016); and FTC v. Advocate Health Care Network et al No. 1:15-cv-11473, 2017 U. S. Dist. LEXIS 37707 (N.D. Ill.Mar. 16, 2017)

Read full article

MHRA seeks views on the regulation of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged healthcare professionals and the public to give their views on new draft European laws for the regulation of medical devices such as breast and hip implants and hospital equipment, such as dialysis machines.

Medical device regulation continues to be a hot topic of debate following PIP breast implants and the recent safety concerns involving metal-on-metal hips.

The MHRA has been pressing the European Commission to strengthen the current European system of regulation for four years and has now launched a ten-week consultation so that healthcare professionals and the public can give their views on whether new draft legislation from the European Commission goes far enough in the following areas:

Read full article