The FDA (U.S Food and Drug Administration), an agency within the U.S Department for Health and Human Services is ‘working around the clock’ to help temporarily redefine legislative measures in support of the fight against the global Coronavirus pandemic.
The regulatory body has been working closely with hospitals, healthcare professionals and PPE manufacturers to understand supply chain demands and have recently issued guidance on several measures they will take to help save lives.
These measures include:
- Reducing production delays caused by premarket reviews to ensure ventilation devices get to market immediately.
- Allowing non-medical device manufacturers (such as automobile manufacturers) to start immediate manufacture of ventilation parts.
- Allowing the use of ventilators in the health system intended for other environments (i.e. industrial).
- And encouraging overseas manufacturers to distribute, where they can, ventilation products in the U.S.
The FDA are helping manufacturers by easing the process of bringing healthcare products to the U.S market in a bid to be as flexible as possible in supporting the U.S Healthcare System.
For the full FDA guidance you can read the full statement issued via their website.
Here in the UK, Perfectus Biomed are fast-tracking efficacy testing for disinfectants and medical devices in the UK’s fight against Coronovirus. Find out here how we can help you today.