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Welcome to the March-April 2018 edition of The Protocol Link Newsletter! We hope your 2018 is off to an exciting start as we bring you up-to date with noteworthy news you may have missed, industry articles authored by our own Protocol Link employees, and conclude with A Word From Our Staff.

 

We hope you enjoy the latest edition of our Newsletter and we look forward

to hearing from you!

 

Noteworthy Links
On January 30, 2018 FDA issued two updated final guidance documents on medical device submissions review acceptance, "Refuse to Accept (RTA) Policy for 510(k)s and "Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)". The updated 510(k) and PMA guidances replace final versions published in 2015 and 2012, respectively.
 
 



Authored by
Dale Kelley
Deviations. Nobody likes them, but they happen in even the best organizations. What comes next can make or break your reputation with regulators, clients, and potentially damage your public image. Many recent 483s and Warning Letters contain the phrase "There is a failure to thoroughly review any unexplained discrepancy...", as FDA continues to take manufacturers to task for their approach to investigating deviations. Among the complaints are: lack of thoroughness, performance or completion is not timely, product was released before investigations were completed, related batches or processes were not evaluated, corrective actions were not effective, or no investigation was performed.



The US FDA works with industry and state partners to publish press releases and other public notices about recalls that may potentially present risk to the consumer or user of the product. The portal through which the public becomes aware of the recall information is the agency's weekly, web-based Enforcement Report. Historically, recall information does not arrive fast enough to the public. They first go through classification based on the severity of the hazard (Class I-Highest, Class II-Intermediate, Class III-Lowest). These classifications can sometimes take weeks or even months when FDA needs to conduct a complex evaluation.




A Word from Our Staff


Protocol Link has an extensive talent acquisition process to identify the right candidate(s) for each project where supplemental skills and subject matter expertise is required. Consultants are interviewed multiple times by company SMEs before Protocol Link assigns the right talented consultant(s) to the project. Additionally, each project has a company SME and Senior Leadership support at all stages of the project! This approach brings a comfort and confidence to our clients that the project will be completed the right way, every time. This is evident by the repeat opportunities Protocol Link receives from our clients.

Ankit Patel
Director, Protocol Link
  

 

Protocol Link recently launched two new service categories showcasing our capabilities in Project Management and Device and Diagnostics!

 

These services have always been at the core of our expertise. The new services rollout was an opportunity to highlight and freshen what we've already been providing to our clients for the past 22 years.