FCC to Explore Options for Improving RF Receiver Performance

The U.S. Federal Communications Commission (FCC) is seeking public comments and suggestions for improving the performance of radio frequency (RF) receivers.

According to a Notice of Inquiry, the Commission believes that its efforts to improve efficiencies in spectrum management need to expand to include all aspects of wireless systems, including both transmitters and receivers. Although current regulations applicable to transmitters implicitly acknowledged receiver performance, the Commission says recent advances in receiver technology and the development of more interference-resistant receivers potentially offer additional opportunities to improve spectrum management efficiencies.

The Commission says that its Inquiry will investigate a range of options for fostering improved RF receiver performance, including industry-led voluntary measures, new policies and guidance from the Commission and, of course, updated or revised rules. The expectation is that a thorough evaluation of all of these options will clear the way for the introduction of new spectrum-based services in the same or nearby frequency bands, and help the U.S. maintain its global leadership in wireless technologies.

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain its criteria for assessing whether a medical device premarket notification (510(k)) submission meets the agency’s minimum requirements for substantive review.

Under the Medical Device User Fee and Modernization Act (MDUFA) and its successive amendments, the FDA must meet performance goals related to the agency’s review of medical device submissions, based on the timeliness of those reviews. The FDA’s Refuse to Accept (RTA) policy provides for an early review of all submissions in accordance with specific acceptance criteria and enables the agency to inform a submitting party whether its submission is “administratively complete” within 15 days of its filing.

The FDA says that the guidance, titled “Refuse to Accept Policy for 510(k)s,” is intended to ensure consistency in acceptance decisions made by the agency and to help submitters better understand the types of information needed by the FDA to conduct its review.

The guidance includes several appendices that provide detailed “Acceptance Checklists” to be used by device manufacturers to verify that their submission for Traditional, Abbreviated, or Special 510(k) notification meets the FDA’s requirements for review by the agency.

According to the FDA, the guidance will promote a more efficient approach to the review of medical devices by reducing review backlogs and clearing a path for the prompt review of safe and effective medical devices. But, like all guidances, the FDA’s guidance on its RTA policy represents only the agency’s current thinking on the topic and is not binding on either the FDA or the public.

Smartphones with the Highest Levels of Electromagnetic Radiation

Recent research posted to a popular financial industry website shows that certain smartphone models may pose a higher potential safety risk due to the levels of electromagnetic radiation they produce.

Data from the German Federal Office for Radiation and posted to the Bankless Times website ranks ten popular smartphone models by the specific absorption rate (SAR) levels they emit. At the top of the list was the Motorola Edge smartphone model, which reportedly has a SAR level of 1.79 W/Kg, closely followed by the ZTE Axon 11 5G, with a SAR level of 1.59 W/Kg, and the OnePlus 6T model smartphone, with a SAR level of 1.55 W/Kg.

In the U.S., the Federal Communications Commission (FCC) mandates a maximum SAR for smartphones of 1.6 W/Kg.

The article ends by sharing the FDA’s recommendations for minimizing exposure to cell phone radiation, including limiting the time you spend using your smartphone and using the available hands-free features.

FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than 650 medical devices designations under its Breakthrough Devices Program.

The Breakthrough Devices Program, which replaced the FDA’s earlier Expedited Access Pathway (EAP) program in 2019, is a voluntary program intended to provide patients and healthcare providers with more timely access to advance medical devices and device combination products. The Program offers device manufacturers a prioritized review of their submissions and direct access to FDA experts to address issues that develop during the premarket review phase.

To be eligible for designation under the Program, a device must meet two criteria, as follows:

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions; and
2. One of the following:

1. Represents a breakthrough technology;
2. No approved or cleared alternatives exist;
3. Offers significant advantages over existing approved or cleared alternatives; or
4. Device availability is in the best interest of the patient.

According to the latest data available, the FDA has granted 657 Breakthrough Device designations as of March 31, 2022. This includes 147 designations in 2020, 216 in 2021, and 64 for the year to date. Cardiovascular and neurological devices dominate the types of breakthrough designations so far, with 158 and 114 designations respectively.

FDA Clarifies Cybersecurity Recommendations for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that contains recommendations for medical device manufacturers on ensuring the security of their devices from cyberattacks.

Published in the U.S. Federal Register, the updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” provides recommendations on security measures that manufacturers should consider across a device’s entire lifecycle. Some specific recommendations include:

• Adopting a secure product development framework to help reduce the number and potential impact of cybersecurity vulnerabilities during the useful life of a device;
• Developing a software bill of materials to track both manufacturer-developed and third-party device and device software components; and
• Ensuring that devices can be updated as necessary to protect against emerging threats.

The draft guidance also encourages device manufacturers to include documentation regarding cybersecurity protections as part of most FDA premarket submission applications, including 510(k) and PMA submissions.

Senate Introduces Medical Device Security Act

The U.S. Senate has introduced a bipartisan measure that would help to ensure the security and integrity of medical devices by implementing mandatory premarket cybersecurity requirements.

Introduced by Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI), the “Protecting and Transforming Cyber Health Care Act, otherwise known as the PATCH Act, would amend the Federal Food, Drug, and Cosmetic Act to “require…the inclusion in any premarket submission for a cyber device of information to demonstrate a reasonable assurance of safety and effectiveness throughout the lifecycle of the cyber device.”

Companion legislation was previously introduced in the U.S. House of Representatives by Michael Burgess (R-TX) and Angie Craig (D-MN).

If approved by both Houses of Congress and signed by President Biden, the PATCH Act would authorize the FDA to require device manufacturers to demonstrate compliance with many of the recommendations contained in the agency’s draft updated guidance on cybersecurity in medical devices.

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