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June 23 — The FDA won't enforce regulations on computer systems used to store, display or collect medical data because they pose a low risk to patients, according to a draft guidance released June 20.
The Food and Drug Administration in the guidance said it wouldn't enforce compliance with any of its previous regulatory controls on the products, called medical device data systems (MDDS). The result should be a reduced burden for developers, the agency said.
“The FDA is issuing this draft guidance document to inform manufacturers, distributors, and other entities that the agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health,” the agency said in the draft.
In 2011, the FDA issued a rule that down-classified medical device data systems from class III (highest risk, needing premarket approval) into the lowest-risk class I (general controls). That regulation exempted the MDDS from the 510(k) premarket review process but still subjected them to quality standards.
Most lower-risk medical devices reach the market by way of the 510(k) premarket notification process, which grants marketing clearance if a device is deemed “substantially equivalent” to a device already on the market. The premarket approval (PMA) application process is much more stringent, and requires clinical data.
In a June 20 blog post accompanying the draft, Bakul Patel, a senior policy adviser to the director of the FDA's Center for Devices and Radiological Health, said since the 2011 rule was issued, the FDA “has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.”
Medical device data systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store, or convert medical device data for future use, in accordance with a preset specification, the FDA said.
A medical image storage device provides electronic storage and retrieval functions for medical images. A medical image communications device provides electronic transfer of medical image data between medical devices, the agency said in the draft.
The agency published a Federal Register notice for the draft guidance on June 25 (79 Fed. Reg. 36,072), with the docket number FDA-2014-D-0798. Comments are due Aug. 25.
The FDA, along with the Federal Communications Commission and the Office of the National Coordinator for Health IT, released a proposal in April for a risk-based strategy to regulate health information technologies.
Since the agency said the MDDS poses such a low risk to patients, the draft guidance proposes to essentially leave their regulation to the ONC's voluntary standards.
FDA's regulatory oversight of health IT products is focused on the devices that pose higher risk to patients, the agency said. Since the agency said the MDDS poses such a low risk to patients, the draft guidance proposes to essentially leave their regulation to the ONC's voluntary standards.
“While every medical device and procedure carries a certain level of risk, the health IT report proposes a risk-based framework—where we use our regulatory tools, resources, and expertise where they are most needed—and that's with devices that carry greater levels of risk,” Patel said in the blog. “This allows developers of medical device data systems to focus on making these products better able to operate amongst various devices and technology systems—resulting in stronger products.”
Bradley Merrill Thompson, an attorney with Epstein Becker & Green in Washington and co-founder of the mHealth Regulatory Coalition, told Bloomberg BNA June 20 the guidance should be welcomed by manufacturers.
“There's no reason to waste industry, or FDA resources on really low-risk technology,” Thompson said. “It's de-regulatory in an area where compliance didn't really add any protections. I applaud FDA for taking this step.”
However, Thompson said he wasn't sure why the FDA decided to issue a draft guidance, instead of just amending the regulations in a rule.
“There's a regulation on the books that needs to be changed,” Thompson said. A guidance document is nonbinding, and merely expresses the FDA's current opinions on a particular topic. “It's a sloppy way to regulate,” he said.
A rulemaking process is more formal, and the agency is able to respond to comments with a proposed rule, Thompson said. “I appreciate the desire for speed, but I hope they do follow this up with a rulemaking very quickly.”
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The draft guidance is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm.
The Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2014-06-25/html/2014-14769.htm.
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