When a foreign establishment engages in the production of a medical device imported into the United States (US), it is mandatory to designate a US agent for that establishment. The US agent serves as the point of contact for any US Food and Drug Administration (US FDA) communication related to the foreign registered facility.
Electronic Labeling (e-labeling) is a medical device labeling alternative to traditional paper labeling. It entails the use of electronic media such as CD-ROMs, DVDs, or websites to provide consumers/users with label information. There are numerous benefits of e-labeling in the medical device industry. The most significant advantages are the following:
A 510(k) or a pre-market notification is a submission made to the United States Food and Drug Administration (US FDA) to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent to a legally marketed or a predicate device. The following are the three (03) types of 510(k) that a medical device manufacturer can submit:
In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
Post-approval change management is the process of monitoring and maintaining the safety, effectiveness, and performance of a medical device after it has received Regulatory approval and has been placed on the market. This process involves continuous evaluation and management of changes to the device, including changes to its design, labeling, manufacturing, and usage. The objective of post-approval management is to ensure that medical devices continue to meet Regulatory requirements and provide the intended benefits to patients and healthcare providers.
Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).
With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion. The wireless medical devices utilize radiofrequency communication such as wi-fi, Bluetooth, cellular or mobile phones. Interoperability is the key feature of these technologies, and all the related concerns are applicable.
The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022. This list of guidance documents conveys a degree of transparency (in terms of where the regulator plans to commit resources and potentially increase scrutiny over the coming year and how manufacturers may be impacted in terms of compliance) for the medical device applicants and registrants who are willing to enter the USA market.
The FDA CDRH has divided its list of guidance documents into three (03) sections:
As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight. But, for the highest-risk Class III devices, the FDA uses the most stringent Regulatory control – the Premarket Approval Process.
