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.
A “predicate device” is a medical device that has been previously approved by the US Food and Drug Administration (US FDA) and is already on the market, which serves as a reference point for new medical devices seeking approval through the FDA’s 510(k) clearance pathway.
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:
A 510(k) submission for medical devices is a mandatory process to receive market clearance in the USA. While the submission process may not be onerous, figuring out where and how to begin can be daunting. However, the US FDA provides ample information in its guidance documents to assist the medical device manufacturers for a smooth 510(k) submission. Making maximum use of the information provided in the guidance is a key to a better understanding of device launches in the US market.
