Regulatory Affairs

ARTICLES

CDRH Finalizes Guidances on 510(k) Submissions

The best way to improve innovation and safety in the 510(k) program “is to drive innovators toward reliance on more modern predicate devices or objective performance criteria,” said CDRH Director Jeffrey Shuren. Read More

FDA Issues Warning to Indiana Devicemaker

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More

PRODUCTS

Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript

$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. View

Medical Device Warning Letters – Webinar Recording/Transcript

$287.00
Are you protected from the Forgotten Five most cited warning letter observations? If you’re not sure, you’re not alone. The Forgotten Five are not frequently discussed and have not generated much corrective information. In other words, the Forgotten Five are the highest-risk areas that offer you the most potential to prevent inspection issues. View

Transparency and the New Medical Device Reporting Rules – Webinar Recording/Transcript

$287.00
Do you have a handle on the changes you may have to make to your MDR program as a result of the Voluntary Malfunction Summary Reporting (VMSR) program? View

Using IT to Improve Data Integrity – Webinar Recording/Transcript

$287.00
Is IT a fully vested member of your data integrity team?  The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View

The AI Revolution – Webinar Recording/Transcript

$287.00
AI is changing the face of image analysis. How will the FDA keep pace with the evolving nature of these technologies while still ensuring that their safety and effectiveness are maintained? While there are still many issues the agency must work through, you need an understanding now of the FDA’s approaches to AI-based image analysis. View

Clarity on Clinical Investigations – Webinar Recording/Transcript

$287.00
The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View

Preparing for a MDSAP Audit – Webinar Recording/Transcript

$287.00
Devicemakers that export into Canada, Japan, Australia and Brazil face important changes to the audit and inspection process as the new Medical Device Single Audit Program (MSDAP) goes into effect. View

510(k) Change Analysis – Webinar Recording/Transcript

$287.00
The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes. View

Data Integrity – Webinar Recording/Transcript

$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






View

Wearables and Sensors – Webinar Recording/Transcript

$287.00
The rapidly evolving landscape for wearables and sensors is having a mighty impact. Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization View

Cybersecurity & Privacy Risks for Medical Device Companies – Webinar Recording/Transcript

$287.00
Cybersecurity issues are public health issues: Are your devices and processes at risk? View