2018 Manufacturing Medical Specialization 
The Medical Futurist
JUNE 21, 2025
However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Are 3D printed and digital contact lenses the future?
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
SEPTEMBER 26, 2022
Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).
FDA Law Blog
OCTOBER 25, 2021
The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.
FDA Law Blog
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.
Expert insights. Personalized for you.
98 
Let's personalize your content