A Look Back at 2015: Regulatory Reform, Safety, Inspections

2015 was a year of significant regulatory developments around the world. The Indian government began laying the groundwork for a complete overhaul of the country’s medical device regulations. Meanwhile, EU officials have been unable to reach agreement for proposals on medical device and in vitro diagnostics regulation. The 21st Century Cures Act was blessed by the U.S. House of Representatives. The focus also was on inspections and audits. The EU signed on as a full observer to the International Medical Device Regulators Forum’s single audit program. China’s FDA warned that devicemakers can expect surprise inspections. In terms of safety, Ireland launched a medical device vigilance system. Meanwhile, concerns were raised over the risks of duodenoscopes, morcellators and cybersecurity. Finally, the FDA moved a step closer to new leadership, with Robert Califf getting nominated as commissioner.

Regulatory Issues

India proposed an amendment to the country’s Drugs & Cosmetics Act of 1940, although the measure has been tabled in the Parliament. Subsequently, the Health Ministry proposed changes to the Drugs & Cosmetics Rules to regulate medical devices separately from pharmaceuticals through the law ministry. The legal authority is greater with the statute versus the rules, but the Association of Indian Medical Device Industry still welcomed the proposal, saying it would pave the way for greater investment and R&D in the country.

In the U.S., Robert Califf was nominated as FDA commissioner, to fill a void left by Margaret Hamburg. AdvaMed applauded President Barack Obama’s decision to nominate Califf, saying his background as one of the nation’s preeminent cardiologists allows him to understand the value that medical technology brings to improving patient outcomes. However, the nominee faced disapproval from Democratic presidential nominee Sen. Bernie Sanders (I-Vt.), who cited Califf’s so-called “cozy relationship with industry.”

The House of Representatives passed the 21st Century Cures Act, which includes improvements to the FDA’s premarket program for medical devices. The bill includes the establishment of an expedited pathway for breakthrough, innovative technologies, but also would apply Medicare rates for durable medical equipment to Medicaid. The measure has stalled in the Senate.

The FDA is planning to issue final guidance in 2016 on how it will enforce the regulation of laboratory-developed tests. Meanwhile, China’s State Council unveiled guidelines intended to make the device approval process more science-based and efficient.

Brazil’s president issued a decree implementing last year’s anticorruption law, allowing for stiff fines and penalties to devicemakers involved in bribing government employees.

In Europe, a trialogue has been under way between the EU Council, Parliament and Commission for proposals on medical device and in vitro diagnostics regulation. It appeared the parties would not be able to reach an agreement by the end of this year, due to too many outstanding political issues, Erik Vollebregt, an attorney with Axon Lawyers in the Netherlands, tells IDDM. Still, experts anticipated a further reduction in notified bodies, and advised devicemakers to choose their notified bodies carefully.

Risks & Safety

In the EU, the debate over device regulations on reprocessing was compounded by reports of outbreaks of antibiotic-resistant superbugs in the U.S. linked to the use of reprocessed duodenoscopes. Indeed, the FDA tightened reprocessing rules in response to an outbreak of antibiotic-resistant bacteria linked to duodenoscopes.

Issues surrounding the risks of power morcellators remained a hot topic, following an FDA safety alert issued last year saying the instrument’s blades could spread unsuspected cancers in as many as one in 352 cases. The Federal Bureau of Investigation launched an investigation into whether major devicemakers and their customers routinely broke the law by failing to report adverse events related to uterine morcellation.

Ireland launched a national eALert system intended for healthcare facilities to help prevent recurrences of medical device-related adverse events. Implementation of the system coincided with the launch of a tool that provides opportunities for service areas to gain an informed picture of the quality of services and practices in relation to device equipment.

Elsewhere, New Zealand finalized an update to the code for executing medical device recalls, while Malaysia issued new rules on incident reporting. South Africa proposed guidelines on recalls and withdrawals.

Cyberattacks were highlighted as a risk, with the U.S. Inspector General of HHS saying networked devices pose a security threat. A report by Forrester Research predicted that hackers will target medical devices for cyber extortion as early as next year.

Inspections & Audits

FDA investigators were busy conducting quality system inspections at international facilities, with inspections at foreign manufacturers jumping by more than 29 percent between 2013 and 2014 — from 460 to 594.

China’s FDA issued guidance warning that devicemakers could expect surprise inspections.

The EU signed on as a full observer to the International Medical Device Regulators Forum’s single audit program. MDSAP pilot full members are the U.S., Australia, Brazil, Canada and Japan. — Jonathon Shacat