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Dive Brief:

• The U.S. Food and Drug Administration is asking for public input on the transition to at-home care and how it can support enabling technologies.
• As part of its push to advance health equity, the FDA has posed a series of home-care questions to the medtech industry, including a query about how it can support the development of devices for use in non-clinical care settings.
• Other questions cover how digital health technologies can support home-based healthcare, the device design attributes that facilitate use outside of clinical settings and methods for generating data to inform regulatory reviews.

Dive Insight:

The development of remote patient-monitoring devices and other connected medical technologies has made it possible to treat more patients at home. In theory, home care can help reduce costs and risks associated with spending time in healthcare facilities and lessen burdens on patients. The COVID-19 pandemic accelerated uptake and validation of telehealth and remote monitoring, setting the stage for wider use of the technologies.

In its request for comment, the FDA’s Center for Devices and Radiological Health said it is committed to “facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, for example, medical devices intended for use in the home.” The questions posed by the FDA cover the information it may need to deliver on that promise. 

Some of the questions are broad, covering the factors that “effectively institute patient care that includes home-based care” and the medical procedures that are ideal for transitioning to the home. Other questions focus on what the FDA can do. The agency wants to know how it can facilitate access to medical technologies when people are unable or unwilling to access care in clinical settings.

Officials said the interest in allowing people to access care wherever they are is consistent with the FDA’s goal of advancing health equity. One question asks what digital health technology design attributes “could better facilitate their use by diverse patient populations outside of a clinical setting” and what other factors can improve acceptance in older adults and non-English speakers. 

The FDA is accepting comments until the end of August.

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Nonagon Enables Clinical-Grade Remote Examinations for Heart, Lungs, Abdomen, and More, Potentially Improving Health Outcomes and Reducing Hospital Visits

CAESAREA, ISRAEL, April 19, 2023/EINPresswire.com/ — Nonagon, a fast-growing medical device company based in Israel and the US, has received FDA clearance to sell its N9+ device as an over-the-counter product, making remote patient examinations more accessible than ever. The Nonagon N9+ device allows for clinical-grade remote examinations of various health parameters, including the heart, lungs, abdomen, oxygen saturation, ears, mouth/throat, skin, and body temperature, and automatically documents and shares exam results with physicians via telehealth, potentially contributing to better patient care and outcomes.

“We are thrilled to receive FDA clearance for the Nonagon N9+ device, which brings us one step closer to our mission of making remote digital medicine clinically reliable and accessible to the community,” said Alon Natanson², CEO of Nonagon. “This clearance allows us to offer a cutting-edge solution that empowers patients to proactively manage their health and enhances the capabilities of healthcare providers to remotely monitor and diagnose patients.”

The Nonagon N9+ device will soon be available on the company’s website in June, with plans to launch it in broader distribution shortly thereafter.

With its user-friendly interface and advanced features, the Nonagon N9+ device is poised to revolutionize the healthcare industry by reducing unnecessary in-person visits and possibly improving health outcomes. The device has the potential to greatly benefit patients.

Omer Maman
Nonagon

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Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available to manufacturers of medical devices, drugs and biological products, and foods during the public health emergency. Several of these guidance documents have been modified, updated, or withdrawn as circumstances have changed, and on March 13, 2023, the FDA issued a notice in the Federal Register that outlines how it intends to unwind a large swath of COVID-19-related guidance documents that are still in effect. FDA sorted 72 COVID-19-related guidance’s into several categories, based on how long and in what form they will continue to be in effect after the expiration of the public health emergency (PHE) declaration, which is expected on May 11, 2023.

1. Guidances that will no longer be in effect upon expiration of the COVID-19 PHE declaration

FDA identifies the following 22 guidance documents that will no longer be in effect upon expiration of the COVID-19 PHE declaration on May 11, 2023, noting its determination that these guidances are no longer needed because their recommendations have been incorporated in other guidance documents and/or stakeholders are no longer relying on them as evolving COVID-19 conditions have allowed more customary operations to resume.

The Agency specifically notes that with respect to the withdrawal of the guidance regarding exemption and exclusion from certain requirements of the Drug Supply Chain and Security Act (DSCSA), the Agency retains authority under the DSCSA to grant waivers, exemptions, and exceptions, as needed, to avoid disruption and allow continued distribution of covered products beyond the expiration of the PHE declaration.

2. Guidances that FDA is revising to continue in effect for 180 days (or potentially longer) after the PHE declaration expires

FDA identifies a second category of guidance documents that will be discontinued in connection with the expiration of the PHE declaration, but with a 180-day wind-down period to allow for “orderly transition.” The Agency identifies the following seven guidance documents that will continue in effect for 180 days after the PHE declaration expires and will no longer be in effect after November 7, 2023.

The Agency also identifies the following 15 enforcement policy guidance documents that will continue in effect for 180 days after the PHE declaration expires, unless FDA provides a different intended duration once FDA finalizes the Agency’s draft guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” (December 2021). For these guidance documents, FDA indicates that it intends to finalize the draft device enforcement policy transition guidance “as soon as practicable.” For details of FDA’s proposed transition plan for these guidance’s, see our prior Alert discussing the details of FDA’s draft device enforcement policy transition guidance.

3. Guidances that FDA plans to revise within 180 days following the expiration of the PHE declaration

FDA identifies the following 24 COVID-19-related guidance documents that it plans to update and retain after the expiration of the PHE declaration. The Agency indicates that these guidances will remain in effect for 180 days after the expiration of the PHE declaration, and that anytime within those 180 days, the Agency will further revise each guidance based on comments received and the Agency’s experience with implementation. Of note, this category includes the guidance regarding the conduct of clinical trials of medical products and the guidance regarding remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities.

For each of the guidances in this category, once a revised final guidance is issued, it will supersede the current version of such guidance. FDA explains that the Agency could revise a guidance “so its duration aligns with an applicable declaration” that enables FDA to issue emergency use authorizations (EUAs) or “by removing language describing intended duration” altogether.

4. Guidances that are not tied to the expiration of the PHE declaration

FDA identifies the following four guidance documents whose duration is not tied to and will remain in effect after expiration of the COVID-19 PHE declaration.

FDA recently revised the two above-listed guidance documents related to COVID-19 tests to state that their policies are intended to remain in effect for the duration of FDA’s declaration that allows for the issuance of EUAs for COVID-19 tests.

With respect to EUAs more generally, the Federal Register notice states that FDA intends to finalize “as soon as practicable” its December 2021 draft guidance regarding “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the COVID-19 Public Health Emergency.” For details of FDA’s proposed transition plan for these medical device EUAs, see our prior Alert discussing the details of FDA’s draft EUA transition guidance.

Last, FDA reserves the right to alter its approach for any of the individual guidance’s discussed above should circumstances change. FDA indicates that should the Agency alter its approach for a particular guidance, the Agency will do so consistent with its good guidance practices regulation, which generally allows for public comment prior to implementation, unless FDA determines that prior public participation is not feasible or appropriate.

^[1] The PHE declaration was originally issued on January 31, 2020, and subsequently renewed by the Secretary of Health and Human Services (HHS) pursuant to the authority under Section 319 of the Public Health Service Act.

^[2] The final version of the device enforcement policy guidance was transmitted to the Office of Information and Regulatory Affairs (OIRA) within the White House Office of Management and Budget (OMB) for review on March 10, 2023.

^[3] The HHS Secretary declared on February 4, 2020, pursuant to the authority under Section 564 of the Federal Food, Drug, and Cosmetic Act, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of novel coronavirus (2019-nCoV).

^[4] The final version of the transition plan for medical devices issued EUAs guidance was transmitted to the OIRA for review on March 10, 2023.

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