medical devices – Duane Morris Life Sciences Law

September 23, 2024 by Duane Morris

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

Read the full Alert on the Duane Morris LLP website.

July 11, 2023 by Duane Morris

Minor Procedural Updates to FDA Guidance on Q-Submissions

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by the FDA to track the requests for feedback and interactions between the FDA and medical device companies prior to submitting for FDA approval. The 2023 guidance provides updated resources and tools for medical device companies, or submitters, looking to request feedback from the FDA during the development process of potential or planned medical devices.

Read the full Alert on the Duane Morris LLP website.

July 26, 2021 by Duane Morris

FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).

To read the full text of this Duane Morris Alert, please visit the firm website.

March 5, 2021March 5, 2021 by Duane Morris

Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices

The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices. The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.

To read the full text of this post by Duane Morris attorney Sharon O’Reilly, please visit the Duane Morris Products Liability Blog.

November 10, 2020November 10, 2020 by Duane Morris

Could COVID-19 Data Help Medical Device Manufacturers Accelerate the FDA Approval Process?

Medical device shortages and shortcomings during the COVID-19 pandemic have led the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to many medical devices manufacturers. Were it not for these EUAs, these manufacturers would be unable to market their devices, as their FDA applications would still be pending. Once the present “emergency” ends, these EUAs will expire, and manufacturers will again be unable to market their devices for the indications cleared under the EUA.

Still, the real-world evidence (RWE) gained about these devices while marketed under the EUA need not be lost with the passing of the pandemic. Once the pandemic ends, manufacturers should be able to use the data collected to support their pending applications for market clearance and for new indications for already-cleared devices.

To read the full text of this article by Duane Morris partners Frederick R. Ball and Erin M. Duffy, please visit the Wharton Health Care Management Alumni Association website.

October 20, 2020 by Duane Morris

3D Printing in the Life Sciences: Mitigating the Risks

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality. Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

August 6, 2020 by Duane Morris

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

To read the full text of this Duane Morris Alert, please visit the firm website.

July 9, 2020 by Duane Morris

FDA Issues Guidance on Procedures for Device Establishment Inspections

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

To read the full text of this Duane Morris Alert, please visit the firm website.

March 16, 2020March 16, 2020 by Duane Morris

U.S. Trade Rep. Implements New Section 301 Exclusions for Certain Medical Products in Wake of Coronavirus (COVID-19)

As concerns surrounding coronavirus (COVID-19) escalate, U.S. trade policy is aligning with the country’s medical needs. On March 10, 2020, the United States Trade Representative (USTR) announced new Section 301 exclusions for certain kinds of Chinese-origin medical products. Although the USTR previously levied Section 301 duties as high as 15 percent against these products, the announced exclusions exempt them from Section 301 duties until September 1, 2020. Significantly, the new exclusions are retroactive in nature so that entities can seek refunds of the Section 301 duties that they have paid on the excluded products dating back to September 1, 2019. Assuming the USTR continues prior procedures, it is expected that the importing community will be allowed to submit written comments to support extensions of the exclusions.

This round of exclusions follows previous rounds granted by the USTR, but it represents the first since the coronavirus has taken center stage for the Trump administration. Although the USTR did not identify the coronavirus or the nation’s healthcare infrastructure as a factor in deciding to grant certain exclusions, these most recent exclusions may have been influenced by the current medical emergency. Additionally, a prime consideration was whether a particular product is only available from China, among other reasons.

View the full Alert on the Duane Morris LLP website.

January 14, 2019 by Duane Morris

FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP

Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on Data Integrity and Compliance with Drug CGMP on December 12, 2018. The Final Guidance is in a Q&A format and provides detailed instructions to the industry that reflects the FDA’s current thinking on data integrity.

Read the full Duane Morris Alert.