CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

Regulatory NewsRegulatory News | 22 October 2018 |  By 

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine individual premarket testing recommendations for ophthalmic optical coherence tomography (OCT) devices.
Under the pilot program, the individual premarket testing recommendations CDRH staff will seek to refine in collaboration with participating manufacturers are aimed at enabling greater consistency in 510(k) submissions for OCT devices and predictability in the 510(k) process.
The goals are intended to improve premarket reviews overall and reduce the time agency review staff spend on reaching final determinations, CDRH said in a Monday notice. The pilot’s review team will assess the impact of providing individual testing recommendations via greater interactive engagement with OCT manufacturers. Requests for participation will remain open for one year or until the limit of no more than nine participants, due to resource constraints, is met.
Eligibility factors for manufacturers to participate, including intent to submit a traditional 510(k) for an OCT device and commitments to support an interview review process and incorporate FDA feedback into plans for performance testing, are detailed in the notice. Pilot program procedures, such as enrollment and pre-submission phase, are described as well.
510(k) submissions for this device type have been initially submitted without “adequate testing to support substantial equivalence,” CDRH argued, citing a lack of FDA-recognized consensus standards and published guidance on OCT testing recommendations. “This is evidenced by consistent requests for additional information (including new data and analyses) across OCT 510(k) submissions,” CDRH added. “There is a need for a better understanding of premarket testing expectations for OCT devices and dialogue between FDA and OCT manufacturers.”
The announcement marks the launch of a first-of-its-kind voluntary 510(k) pilot program that is limited to a specific device type. It comes after IDx obtained marketing clearance in April for an ophthalmic device powered by artificial intelligence (AI) for the detection of diabetic retinopathy, IDx-DR. 
IDx-DR was evaluated under the de novo pathway, which is intended for the review and classification of novel medical devices, and has been touted by agency officials as the “first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results.” The first FDA-approved artificial iris, which also uses OCT technology, was submitted for review via the premarket application (PMA) pathway by Clinical Research Consultants prior to obtaining approval in May.

Industry reactions

"As we explore partnerships with a variety of OCT manufacturers to develop additional autonomous AI diagnostic solutions, it's great to see the FDA working to continually improve the existing clearance process," IDx spokesperson Laura Shoemaker told Focus. "This could speed up the path to market for new OCT technologies - including those that might one day be paired with AI in frontline care settings."

Shoemaker noted that IDx has "a number of other AI technologies in development that will pair with OCT technologies in the future." OCT technology offers non-invasive imaging tests of users’ retinas.

Optovue, developer of devices with OCT technology, also showed support for the new pilot program. "Optovue is excited to learn that the FDA has recognized OCT technology for a 510(k)-pilot program considering an efficient, risk-based approach to submission," Indu Lakshman, vice president of regulatory affairs and quality assurance at Optovue told Focus. "This is very encouraging for OCT device manufacturers to promote innovation in the development and marketing of products in a timely manner for the management of ophthalmic patient healthcare."

510(k) landscape
The new pilot program follows a string of similar CDRH initiatives aimed at improving the overall 510(k) regulatory review pathway as it provides a less-burdensome approach to reaching the market compared to the more data intensive approaches of the de novo and PMA pathways.
Two new 510(k) pilot programs were announced in September: the new Quality in 510(k) Review Program (“Quik”) to assess whether premarket reviews can be streamlined using CDRH’s eSubmitter software for eligible devices of moderate risk, as well as a pilot program set to evaluate the impact of a revised process for third-party 510(k) reviews.
And all Special 510(k)s submitted to CDRH after 1 October are being evaluated under a new pilot program launched earlier this month in which the agency will seek to evaluate the expanded eligibility of device changes as was proposed in draft guidance issued in September. CDRH also proposed to expand the Abbreviated 510(k) program in draft guidance issued in April, which has raised concerns among trade associations over the intended benefits of an expanded program.
Meanwhile, several factors are playing into CDRH’s efforts around 510(k) programs. These include a rule proposed in September to minimize use of paper copies, a growing body of down-classifications increasing 510(k) eligibility and ongoing plans to create a medical device single review program in collaboration with the International Medical Device Regulators Forum.
Fostering Medical Innovation: Voluntary Pilot Program to Streamline Review of Premarket Notification (510(k)) Submissions for Ophthalmic Optical Coherence Tomography Devices


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