FDA / Regulatory News
FDA moves to electronic premarket submissions
The shift away from paper filings is expected to streamline the review process by making an electronic version of a medical device premarket application immediately available for review. The rule also reduces the number of copies required in electronic format, simplifying requirements andlowering expenses for submitters.
The final rule applies to:
- 510(k) premarket notifications
- Confidentiality of information certifications
- Investigational device exemption (IDE) applications
- Premarket approval applications (PMAs)
- PMA supplements
- Humanitarian device exemption (HDE) applications
How to Determine if Your Product is a Medical Device
The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definitionof a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act:
Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia*, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and whichdoes not achieve its primary intended purposes through chemical action within or on the body of man or other animals
*The United States Pharmacopeia-National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
Product Recalls and Issues
Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps
Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy
The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. They are used primarily in neonatal and pediatric populations in operating rooms, as well as intensive care units for adults.
Smiths Medical became aware of a software issue in the recently updated Firmware Version 1.7.0 for the Medfusion 4000. The issue potentially causes low battery alarms to cease working, which means a user will not receive audible or visual notification that the battery is shutting down.
If the alarm doesn’t sound and the battery shuts down, it could lead to an interruption of therapy that could cause serious injury, adverse events or death. However, no injuries or deaths have been reported, despite 74 complaints related to the software issue.
