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FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act

Agency also launches voluntary pilot program as first step in developing software pre-certification program....more

OCR Announces First HIPAA Settlement with Wireless Health Services Provider

The $2.5 million settlement reflects the agency’s focus on mobile health privacy. On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with CardioNet, a...more

New York Attorney General Settles Claims against Three Health Apps

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

FDA Issues Final Guidance on “Emerging Signals”

Guidance addresses industry concerns about premature public notifications. On December 14, 2015, the FDA issued a final guidance titled “Public Notification of Emerging Postmarket Medical Device Signals” (Final...more

12/21/2016  /  FDA , Life Sciences , Premature Claims

21st Century Cures Act and Medical Device Regulatory Pathways

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more

The 21st Century Cures Act and Its Effect on Digital Health

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

Top Takeaways from FDA Draft Guidance on Software as a Medical Device

FDA’s proposed adoption of an IMDRF document raises questions. On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

FDA Clarifies Policy for Sharing Patient-Specific Data from Devices

Device manufacturers may share patient-specific information from a device with the patient without violating federal privacy requirements....more

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

FTC Creates Web-Based Tool for Mobile Health App Developers

The new interactive tool highlights the relevant federal regulatory schemes, but the high-level analysis may limit its value to mobile health app developers....more

FDA Active on the Device Front for Q1 2016

Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more

Health Apps and HIPAA: OCR Publishes New Guidance For Health App Developers

OCR’s guidance presents hypothetical scenarios and key questions to help app developers determine when they are subject to HIPAA regulations. On February 11, the Department of Health and Human Services’ Office for Civil...more

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

FDA Issues Final Guidance on Reprocessing of Medical Devices

The US Food and Drug Administration (FDA) issued a final guidance document on March 12 titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Although the final guidance was expected...more

3/18/2015  /  FDA , Final Guidance , Medical Devices

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

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