Submitted by kBLASTER Team on
Posted 28 January 2015 By Alexander Gaffney, RAC for RAPS.org
On 27 January 2015, the US House of Representatives' Energy and Commerce Committee's Subcommittee on Health released a new bipartisan draft bill that is set to dramatically alter the ways pharmaceutical and medical device products are regulated in the US. The bill is the product of a bipartisan process known as the 21st Century Cures Initiative. Since its launch in April 2014, the initiative has held more than a dozen roundtables, eight congressional hearings and released five whitepapers—all focused on ways in which Congress might transform the way new treatments are approved and marketed in the US.
The proposed 21st Century Cures Initiative has language regarding many FDA related issues for drugs, clinical trials, devices (both PMA approved and 510(k) cleared), marketing exclusivity, drug advertising and many other issues.
An abbreviated summary of this posted article will focus on sections with issues that could impact the 510(k) clearance process:
Breakthrough Devices
The legislation notes that a device cleared through the breakthrough designation program for devices cannot be used as the basis of a 510(k) application until it has completed its required postmarketing studies.
Predicate Devices
Most medical devices are "approved"—technically "cleared"—in the US through the 510(k) pathway. That pathway requires a device to show that it is substantially similar to an already-approved predicate device.
Section 5066 of the Cures Act seeks to enact one change to that system, which has existed since 1976: FDA wouldn't be able "to refuse to an accept an indication for use (IFU) statement for a device to the extent the predicate for such device has the same indication statement," and FDA would not be allowed to "require … information or data related to an indication other than the proposed indication in the report."
Those are small changes, but could have a large impact for manufacturers looking to reference devices cleared long ago, or just hoping for a more predictable application process.
Regulating Software as a Medical Device
The bill also includes a new effort to overhaul how FDA regulates software, including mobile applications, as medical devices.
Several pieces of legislation have sought to change this dynamic since 2013, including the SOFTWARE Act, the MEDTECH Act and the PROTECT Act.
The Cures Act contains a heavily modified version of the SOFTWARE Act, which simplifies the term "medical software" into two categories: products which FDA can regulate, and those it explicitly cannot regulate.
The bill defines the term "medical software," but the draft also wonders aloud how the committee can ensure products which clearly are medical devices don't use the definition to avoid proper oversight by FDA. The other category defined by the bill is the term "health software," which is generally taken to mean products not intended to treat a specific condition or disease, but intended to assist caregivers more generally, including by managing healthcare data.
FDA would be permitted to regulate certain types of medical software, but not health software. FDA would be tasked with determining which types of regulatory software it would regulate within two years. Within two years of the bill becoming law, the FDA would be tasked with development of a new regulatory program specifically to oversee such software. Additionally, any software classified as medical would not be required to be approved or cleared under sections 513, 510(k) and 515.
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