Archives: Medical Device

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

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

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

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

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

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

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

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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