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On Wednesday, June 8, 2016, a bill was introduced in Congress that would, if passed, amend the Federal Food, Drug, and Cosmetic Act to require physicians and physicians’ offices to submit reports to FDA on hazards relating to medical devices. The rationale behind the proposed amendment is to give the FDA earlier notice of risks associated with medical devices used in the United States. H.R. 5404 comes in response to a delay in reporting of potential risks associated with the use of laparoscopic power morcellators, but it has implications for the entire medical device industry.

Reporting Requirements for Physicians and Physicians’ Offices

If passed, H.R. 5404 would expand the class of entities required to report adverse events to include physicians and physicians’ offices. For purposes of the bill, adverse events are defined to include instances where a medical device has or may have caused or contributed to a death or a serious illness or injury.  A serious illness or injury is one that is life threatening, that permanently impairs a body function, that permanently damages a body structure, or that necessitates medical intervention to preclude permanent impairment or damage.

The FDA already requires hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment facilities,  other than physicians’ offices, to report such adverse events to FDA and/or the manufacturer.  Thus, H.R. 5404 would not change the type of information reported to FDA about hazards relating to medical devices, but could increase the amount of information that FDA receives by placing reporting duties on more people and entities.

Unchanged Reporting Requirements for Medical Device Companies

H.R. 5404 would not place any new reporting requirements on medical device companies. However, existing law requires manufacturers and importers of medical devices to report:

  • Any information they receive that reasonably suggests one of their marketed devices may have caused or contributed to a death or serious injury; and
  • Any information they receive that reasonably suggests one of their marketed devices has malfunctioned in a manner that would likely cause or contribute to a death or serious injury if the malfunction of the same or a similar company device were to recur.


Reports of adverse events have the potential to lead to civil and even criminal lawsuits against physicians, hospitals, medical device companies, and others.  In an effort to encourage reporting, existing law generally prohibits the use of reports to FDA made pursuant to this requirement as evidence in any civil action involving private parties. The only statutory exception is for situations in which the reporting party had knowledge of the report’s falsity. This evidentiary bar applies only in civil cases and does not reduce criminal liability or prevent adverse regulatory action.

Although H.R. 5404 would not directly change the legal obligations or liabilities of medical device companies, it could increase the FDA scrutiny to which their devices are subjected, reinforcing the importance of following best practices in design and manufacturing.  The bill highlights the importance of ensuring product safety, both in design and in quality control, in order to serve customers effectively and reduce litigation risks. The bill also highlights the importance of proactively seeking and responding to information about product performance problems in order to improve product quality and address safety concerns.


Spencer Churchill is an associate in Baker & McKenzie's Compliance & Investigations Practice Group in Washington, DC. He previously worked with the Firm as a summer associate, assisting in risk assessments and helping to advise clients on compliance with the Foreign Corrupt Practices Act (FCPA) and with state ethics regulations. He has been recognized for his pro bono work in DC, worked as a student lawyer at the Harvard Education Law Clinic, and served on the editorial board of the Harvard Journal of Law & Public Policy.


Neil O'Flaherty is a partner in Baker & McKenzie’s Intellectual Property Practice Group in Washington, DC. He has over 25 years of experience involving FDA regulation of medical devices. Mr. O'Flaherty has spoken and written extensively on medical device and other FDA-related topics, including the regulation of mobile medical apps, other medical software products and in vitro diagnostics; inspectional and enforcement authority; clinical trial requirements for devices; device regulatory obligations of hospitals; and the impact of FDA device law on business transactions and agreements.


Daniel Fiedler is an associate in Baker McKenzie’s Dispute Resolution Practice Group in Washington, DC. Prior to joining the Firm, Mr. Fiedler worked as a law clerk for The Honorable Frederick J. Kapala, United States District Court for the Northern District of Illinois. Before entering law school, Mr. Fiedler spent two years working with international youth in Northern Thailand and volunteered for a disaster-relief non-profit organization in the Philippines. During law school, Mr. Fiedler served as an extern with the Public International Law & Policy Group in Washington, DC, and as a legal intern for The Honorable Amy Berman Jackson, United States District Court for the District of Columbia.