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Food and Drug Administration (FDA) Issues Draft Guidance on Transfer of 510(k)s

By Squire Patton Boggs on Posted in FDA, Medical Device, Technology
On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position … Continue Reading

Use of Artificial Intelligence in Healthcare Industry in Mainland China

By Nicholas Chan on Posted in Artificial Intelligence, China, Life Sciences, Medical Device
With breakthroughs in artificial intelligence (“AI”), the healthcare industry has experienced rapid development. Since 2016, China has issued a series of relevant policies, including the “Internet+” Artificial Intelligence Three-Year Action and Implementation Plan, Guiding Opinions on Promoting and Regulating the Application and Development of Big Data in Health and Medical Care and the “Healthy China … Continue Reading

Roadmap to the Phased Transition Process for Medical Devices after Covid-19 Public Health Emergency

By John Wyand, Charli Davis, Jennifer Tharp and Nicole Bothwell on Posted in COVID-19, FDA, Life Sciences, Medical Device
On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products … Continue Reading

The Medical Device Regulation, COVID-19 and Brexit

By Adrian Spooner on Posted in Brexit, COVID-19, EU, Life Sciences, Medical Device
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.  The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the … Continue Reading

Key Health Care Technology Privacy and Cybersecurity Considerations

By Squire Patton Boggs on Posted in Compliance, Cybersecurity, Data Protection, Digital Health, HIPAA, Medical Device, Privacy, Technology
In a podcast interview with Healthcare InfoSecurity, Squire Patton Boggs Partner Elliot Golding addresses evolving healthcare privacy and security issues, particularly complex issues involving Internet of Things (IoT) devices.  This includes addressing new risks when connected devices link to legacy systems, the applicable regulatory environment, and other key issues companies operating in the health care … Continue Reading

FDA Issues Guidance on Clinical and Patient Decision Support Software

By Squire Patton Boggs and John Wyand on Posted in FDA, Life Sciences, Medical Device, Medical Device, Publications
On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (“Draft Guidance”). The Draft Guidance provides clarity on the scope of FDA’s regulatory oversight … Continue Reading

House Committee Chairman Asks HHS to Develop Health Care Cyber Risk Plan

By Squire Patton Boggs on Posted in Cybersecurity, Department of Health and Human Services, Hospitals, Medical Device, Physician Practice
Last week, the Chairman on the House of Representatives’ Committee on Energy and Commerce, Greg Walden (R-OR), sent a formal letter to the Dept. of Health and Human Services (“HHS”) requesting that HHS “develop a plan of action for creating, deploying, and leveraging [bill of materials] for health care technologies.” Walden gave HHS until December … Continue Reading

More Countries Jump on the “Connected Medical Devices Are Risky” Bandwagon

By Squire Patton Boggs on Posted in Cybersecurity, Medical Device
There is an increasingly common recognition that internet-connected medical devices can dramatically improve health outcomes and lower costs, but also create tremendous privacy and cybersecurity risks. In the U.S., the Food and Drug Administration (“FDA”) has already issued substantial guidance regarding device cybersecurity, but other countries are now also jumping on the bandwagon. For example, … Continue Reading

National Institutes of Health Extends Effective Date of sIRB Policy

By Squire Patton Boggs and John Wyand on Posted in Life Sciences, Medical Device, NIH, Policy, Research
Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading

Summary of FDA Statement on Laboratory Developed Tests Issued January 13, 2017

By Squire Patton Boggs on Posted in Compliance, FDA, Medical Device
On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT) synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs.  FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience … Continue Reading

FDA Issues Guidance for Classification Pathways for New Accessory Types

By John Wyand on Posted in Compliance, FDA, Medical Device, Medical Device, Publications
Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law … Continue Reading

FDA Considers Regulating Refurbishers and Other Third Parties

By Squire Patton Boggs on Posted in FDA, International Healthcare, Legislation, Medical Device, Medical Device, Pharmaceutical, Quality and Performance Measures, Regulatory Compliance
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading

FDA Announces Commitment to MDSAP

By Squire Patton Boggs on Posted in FDA, Medical Device
The FDA announced on December 17 that it would participate in the operational phase of the Medical Device Single Audit Program (MDSAP), starting January 1, 2017.  The FDA currently participates in the ongoing MDSAP pilot program, scheduled to run until the end of 2016. The MDSAP program was created by the International Medical Device Regulators … Continue Reading
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