5 bold regulatory predictions for medical devices in 2024

Due to looming deadlines and mounting political pressure, medical device manufacturers in the US and the EU will need additional preparation and sophistication to deal with regulatory bodies this year. Here are our top 5 bold predictions for the device regulatory landscape in 2024.

PREDICTION #1

FDA will release draft guidance for predetermined change control plans (PCCPs) for ANY medical device.

The guidance won't provide much detail, but it will open the door for manufacturers to propose PCCPs during the review cycle. Gaining FDA agreement on a PCCP at the time of submission means manufacturers will not have to dig through the decision flow charts in FDA’s guidance to determine if a product change requires FDA review. Any change covered by the PCCP will simply be handled internally under the manufacturer’s quality system.

FDA received positive feedback for its move towards PCCPs for artificial intelligence/ machine learning (AI/ML) devices. But even so, when CDRH released its annual list of guidance priorities, it was a surprise to see a draft guidance for PCCPs for ALL medical devices. This seems to have flown under the radar for most manufacturers and industry groups.

PREDICTION #2

FDA will end enforcement discretion for laboratory-developed tests (LDTs), and force manufacturers to go through submission review.

LDT manufacturers are accustomed to not having to deal with FDA, who has exercised enforcement discretion for years. Last year, FDA proposed a rule to end enforcement discretion of LDTs and bring them back under FDA purview. 

This topic is a flashpoint for the industry, and even members of Congress are split on whether FDA is making the right decision, or even if FDA has the authority to do this. However, FDA is pressing on. In a joint statement just last week from FDA and CMS, FDA reiterated its commitment to this effort. CMS, who currently oversees LDTs through CLIA regulations, voiced support for FDA in this matter, actually stating that they lack the expertise to effectively regulate LDTs. Federal agencies will typically put up a fight to avoid ceding control of anything to another federal agency, so it can’t be understated just how shocking this is. So, while the expected lawsuits may cause some delays, we ultimately expect that FDA will achieve its goal. 

There are a lot of LDTs on the market, and many seem to be banking on the courts to either delay this effort, or to end it altogether. At some point, the dam is going to break and FDA is going to be inundated with submissions.

PREDICTION #3

The EU Artificial Intelligence Act will become law.

At the end of last year, the EU policy teams agreed on the text of the AI Act, and the EU Parliament is expected to take it up this year. 

If it passes, most AI/ML-powered medical device manufacturers will need to take additional steps before being permitted to market their devices in Europe.

Many manufacturers will need to obtain third-party certification under the AI Act. The good news is that the certification will likely be performed by the same Notified Bodies that already grant CE marks for those manufacturers. The bad news is that Notified Bodies will need to obtain their own certifications first, and the EU has a poor track record of granting these in a reasonable amount of time. Recall that when the EU Medical Device Regulation (MDR) went live, it took almost 18 months before the first Notified Body became certified to grant MDR CE marks. 

PREDICTION #4

The May 2024 deadline for an MDR-compliant quality system will catch a not insignificant number of manufacturers by surprise. 

The transitional period for the EU Medical Device Regulation has been extended several times, due to both the unavailability of Notified Bodies and the pandemic. The deadline for an MDR-compliant CE mark is still a few years away for most manufacturers. 

However, the deadline for compliance with the Quality Management System requirements is still May 2024. Companies that are still marketing under an old MDD CE mark, especially those whose classification went from Class I to Class II or higher under the new MDR, may not be fully prepared for this.

PREDICTION #5

FDA audits and inspections will increase this year, with many manufacturers getting surprise audits for the very first time ever.

The device division of FDA is traditionally focused more on “for cause” inspections than surprise inspections. So, absent any complaints or recalls, most manufacturers don’t expect FDA inspectors to walk through their door out of the blue. This will change soon. 

In Dec. 2023, US Senators Durbin and Blumenthal urged the Government Accountability Office (GAO) to conduct a review of FDA’s medical device recall oversight, specifically citing Philips Respironics’ 2021 recall of sleep apnea machines.

At the same time, FDA has proposed a reorganization of the Office of Regulatory Affairs (ORA), which conducts inspections and investigations for all products under FDA purview. While this was mainly in response to the 2022 Abbott Nutrition infant formula recall, with most press coverage around this development highlighting potential impacts on foods, all agency inspection offices, including those for medical devices, will be impacted.