Medical Device Archives - Page 2 of 4

Medical Device

FDA Decision to Exempt Certain Class II Devices from 510(k) Premarket Notification

On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet the premarket notification requirements under section 510(k) of the Federal […]

Biologics, Medical Device, Pharmaceuticals

Insulin and Glucagon Bioassays

PBL supports testing for a wide array of diabetes medications

With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have expanded as well. Medications for regulating blood glucose levels are […]

Medical Device, Pharmaceuticals

USP 661 Plastic Packaging: Introduction to <661.1> and <661.2>

Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a range […]

Medical Device, News | April 8, 2016

NEW ISO 13485:2016 GUIDANCE PUBLISHED

On March 1, 2016 the International Organization for Standardization published the new edition of the ISO 13485 standard. Previously updated in 2003, the revision places more emphasis on the quality […]

Analytical Chemistry, Medical Device

Detailed Methods for Performing Extractables Testing of Materials

A recent article from the Parenteral Drug Association (PDA) Journal provides some of the best information we have found on methods to determine and characterize extractables. It is definitely suggested […]

Medical Device

FDA Expectations for Reusable Device Reprocessing Validations

In March of 2015, the FDA published a new guidance document titled, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. A draft guidance on the same subject […]

Medical Device, Microbiology

Why Understanding Bioburden and Sterilziation is Key to Medical Device Development

Pacific BioLabs and Nutek used to work closely together to perform the microbiology and sterilization needed for medical device sterilization validation programs. Nutek was bought out by BART and the […]

Medical Device

Evaluation of Immunogenicity and Allergic Reactions to Medical Device Materials and Combination Products

As devices become more complex, biocompatibility and material evaluations must necessarily become more complex and thorough as well. Allergic and immunogenic reactions are a serious safety concern not only for […]

Medical Device

Primer: GLP and Medical Device Studies

Here at PBL, we work with many medical device companies, and no matter whether these companies are new or established, there still seems to be common questions among them. Namely: […]

Analytical Chemistry, Medical Device

Chemical Characterization of Medical Devices: An Overview

At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. To address, and hopefully alleviate some of this confusion, we’ll be […]