Submissions and Approvals

ARTICLES

PRODUCTS

EU-MDR Soft Transition - Webinar Recording/Transcript

$287.00
If you plan to continue putting devices on the European market, you’ll need to implement the EU-MDR. Dan O’Leary will explain the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. View

Medical Imaging - Webinar Recording/Transcript

$287.00
As electronic technology advances, its integration into medical devices — specifically medical imaging devices — challenges the FDA to regulate the integrated devices and still allow new technologies to the market in a reasonable time. J. Lawrence Stevens, RAC — an expert witness for cases involving FDA compliance for medical devices — will discuss the latest FDA trends and how to keep your company competitive. View

FDA’s 2019 Medical Device Regulation Agenda - Webinar Recording/Transcript

$287.00
Jessica Ringel — Counsel, King & Spalding, Washington, D.C. — will discuss how CDRH will prioritize digital health, advance device safety and security, offer more flexibility and options for premarket submissions, sustain high-quality servicing, provide efficient oversight, handle uncertainty in devices and engage patients. View

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. View

FDA’s Plan for Modernizing the 510(k) Pathway - Webinar Recording/Transcript

$287.00
Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She’ll discuss common mistakes and the FDA’s current and evolving expectations for submissions. View

FDA Medical Device Compliance and Enforcement - Webinar Recording/Transcript

$287.00
Bethany J. Hills, Chair, FDA Practice and Aaron Josephson, Senior Director — both of Mintz Levin — will provide a comprehensive understanding of medical device compliance and enforcement trends and the contextual relationship of policy and regulation. View

Regulating Software Used by Life Science Manufacturers - Webinar Recording/Transcript

$287.00
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not. View

Sampling Plans for Quality Audits - Webinar Recording/Transcript

$287.00
Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. View

Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript

$287.00
The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report. View

Medical Device Cybersecurity Risks & Best Practices - Webinar Recording/Transcript

$287.00
Smart medical devices have underlying cybersecurity and privacy risks. FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies. View

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript

$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View

The 510(k) Process - Webinar Recording/Transcript

$287.00
As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View