US FDA's recent congressionally directed actions to exempt reams of devices from 510(k) requirements may have less of an impact on industry and agency workloads than the top-line numbers suggest, according to an analysis performed by Medtech Insight in collaboration with regulatory intelligence firm Graematter Inc. But there are pockets of companies and clinical specialties where the effects might be more pronounced, the analysis found.
In July, FDA issued a Federal Register notice listing several hundred class II devices that it was exempting from 510(k) requirements. (Also see "US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications" - Medtech Insight, 11 Jul, 2017.) That followed an April notice exempting 72 class I devices from pre-market submissions. (Also see "FDA 510(k)-Exempts 72 Devices, Mostly Diagnostics" - Medtech Insight, 12 Apr, 2017.)
The actions were required by a provision in the December-enacted 21st Century Cures Act intended to "decrease regulatory burdens on the medical device industry" and "eliminate private costs and expenditures required to comply with certain federal regulations," FDA stated in its July 11 class II exemptions notice.
Medtech Insight worked with Graematter, applying its regulatory intelligence system to assess, in practice, how much burden might be reduced as a result of the Cures Act provisions and FDA notices. Graematter collects regulatory information from multiple sources, integrating the data into a single system. Consolidating the information into a single proprietary database allows visibility into the interconnections and trends hidden within the data.
Our findings: A small subset of companies will see a tangible impact in terms of regulatory efforts and costs from the exemptions, but most firms will experience relatively small or no impact from the Cures-directed changes. Similarly, the exemptions will have a trivial effect on overall FDA staff workload, but it could be felt by some specific review divisions more than others.
In issuing the July exemption notice for class II devices, FDA identified 244 device product codes slated for full 510(k) exemption. In addition, there were 93 additional examples of partial exemptions. For this analysis, we focused on the 244 full exemptions.
Of the 244 product codes, 85 had previously (in a 2015 guidance document) been tapped by FDA for 510(k) exemption, but had yet to be made official. The Cures mandate triggered the agency to add 159 more codes to exempt. Of the 244 exemptions, 46 codes do not have any cleared 510(k)s where they are the primary code. And 50 devices are under an "enforcement discretion" policy, which means that FDA has chosen to not enforce some or all the regulatory requirements for those devices.
But, certainly, there have been thousands of 510(k)s cleared since 1976 among the newly exempted product codes. Below, we assess, in five graphics, what the 510(k) review and clearance trends – as well as registration and listing data – say about the likely impact of the recent exemptions.
510(k)s Were Declining, But Review Times Nothing To Sneeze At
Among the newly exempted product codes that are linked to 510(k)s, there have 4,378 clearances from 1976-2016. More than 60% (2,780) of those clearances happened before 1996, and, as shown in Figure 1, the number of clearances has steadily declined in recent years, to only 25 in 2016. This reduction likely represents a decline in innovation and/or modifications made to products within these codes, among other possible factors. Of note in this context, 27% (66) of the newly exempted 244 codes did not have active device listings on FDA's registration and listing database in 2016.
510(k)s Cleared For Newly Exempted Codes, 2000-2016
In all years, the proportion of 510(k)s cleared in the exempted code categories compared to the total number of cleared 510(k)s is very small, as shown in Figure 2; for instance, 0.85% in 2016.
510(k)s Cleared Per Year, Newly Exempted Vs. All Others
Interestingly, though, while the 510(k) numbers already dropped before the formal exemptions were announced, the average review times for this mix of products had not declined. The time it took, on average, for FDA to review devices in the now-exempted categories has consistently aligned very closely to overall 510(k) review-time averages, as illustrated in Figure 3.
510(k) reviews for exempted products actually took about seven days longer, on average, than reviews for all other products in 2016, even though the exempted devices have now been found by FDA not to require a 510(k) submission to assure safety and effectiveness. This suggests there could be some individual cases where meaningful resources are freed up for a reviewer to spend time on higher-risk devices.
Average 510(k) Review Days - Newly Exempted Vs. All Others, 2000-2016
The extent of the impact is likely to depend on the clinical classification of the device. As shown in Figure 4, 510(k) clearances granted over the past decade for devices in the exempted categories fell into 17 different review advisory committee categories. Of those, most saw less than 50 clearances during the 2006-2016 period. But two clinical categories stood out as having the most activity and, thus, the most to gain from the exemptions.
Clinic Chemistry was the most common category in terms of the number of exempted codes, and second in number of 510(k)s (128). General & Plastic Surgery, meanwhile, had 15 fewer codes on the exempted list, but 22 more 510(k)s (150) during the 2006-2016 period.
Anesthesiology devices were distinguished by having the highest average review time for the fewest number of 510(k)s (five). Ear, Nose, & Throat products, meanwhile, had the fastest review time average, but only seven 510(k)s cleared.
Average Review Time And 510(k) Numbers For Newly Exempted Codes, By Review Committee, 2006-2016
A Few Firms Will See Substantive Change
A more direct way to assess industry impact is to look at the proportion of companies that have developed products in the exempted categories. This was done by cross-referencing FDA's device registration and listing database with the exempted-code information.
Of the total number of owner/operators registered with FDA, about 6% included devices in the exempted categories among their products. Of those 1,305 companies, only 38 of them have newly exempted codes as greater than 60% of their portfolio. Newly exempted devices account for less than 20% of products for a significant majority of the relevant owner/operators, as illustrated in Figure 5.
Proportion Of Company Portfolios Now Exempt
BASED ON AN ANALYSIS THE NEWLY EXEMPTED CODES CROSS-REFERENCED TO FDA'S MEDICAL DEVICE REGISTRATION & LISTING DATABASE
These most recent exemption listings, while moderate in impact on their own, are not isolated actions. They fit with a trend for an agency that is by-and-large moving in the direction of streamlined requirements and more transparency, both at the direction of the Cures Act and independently.
The Cures Act requires FDA to publish new lists of exempted devices at least once every five years. There currently remain 154 class I devices that have a 510(k) requirement, 41 more that are under an enforcement discretion policy, and 139 class II devices that reside under enforcement discretion. These devices may serve as low-hanging fruit for the agency's next round.