In a post Covid-19 world, the medical device and IVD industry is here to witness growth like never before. With cutting-edge technological innovations and healthcare companies striving to achieve quicker go-to-market momentum, regulatory compliance often takes a backseat putting patient safety at risk. Let us quickly take you through few crucial medical device labeling requirements enforced by the US FDA (Food & Drug Administration) to ensure optimal quality and compliance of your device.
Section 201(k) defines 'label' as a:
‘display of written, printed, or graphic matter upon the immediate container of any article…’
The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper if any there be, or the retail package of such article, or is easily legible through the outside container of the wrapper.
Section 201(m) defines 'labeling' as:
'all labels and other written, printed, or graphic matter
The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
Clear and informative medical device labeling is a crucial element to ensure compliance, high quality, and safety standards of your manufactured device in the FDA regulated US market. Improper or insufficient labeling can lead to product recalls or export bans, resulting in huge financial losses and potential reputational damage for a medical device manufacturing company. Athreva’s specialized team of medical device experts can help you navigate through the complex and time-consuming regulatory compliance requirements and ensure a smooth entry in the stringently regulated US medical device market.