Medical Device manufacturing audits are a necessary evil to industry, yet they have grown to become a burden with the lack of coordination across the regulatory organizations. It is not uncommon for an audit to take place at least once a month, if not more often when one considers the frequency of General Audits and Ad hoc audits. A very expensive exercise to any company, and one has to question at what point are these audits not only a burden, but also a distraction to companies' ability to stay focused on the manufacturing of quality products.
Last week FDA announced at the International Medical Device Regulatory Forum, the launch of the Medical Device Single Audit Program (MDSAP). The intention of the MDSAP program is to utilize a single General Audit, conducted by Medical Device Auditing Organizations, for multiple regulatory bodies. This would eliminate the need for each regulator to conduct their own General Audit. FDA (United States), Canada and Brazil have already committed to the first phase of MDSAP.
For the past several years they have brought the idea of a single audit into action, making great strides over the past few months: drafting documents and processes for the MDSAP. The launch of the program will begin with a few pilots and then move into production. During the pilots FDA (United States), Canada and Brazil will work with volunteer Auditing Organizations (AO) and Medical Device companies to use and test the documents and processes.
The results of the pilot will be recognized by FDA as part of the AO and medical device companies' General Audit. Participants will have the opportunity to provide feedback on streamlining the complex and time consuming audit process, which currently includes over 90 documents and encompass over 50 hours to complete.
The vision for a single audit, where all the members of the IMDRF accept the MDSAP results for the General Audit, is an exponential reduction in time and money spent on audits. Currently, a General Audit takes an average of 4 days. If a medical device company is registered in 10 countries/regulatory entities, they must support an audit for each country/regulatory entity. Those 4 days can quickly turn into 40 days spread across the year; an expensive allotment of time, energy and resources.
Reducing the burden of audits will both decrease the time and cut the cost, making the "playing field" level for all participants. The MDSAP is also the first step towards the Medical Device regulators harmonizing their processes for reducing costs to their constituents. Next, we need to see progress on the approval side of the process, so all patients in the world have access to the most innovative medical devices that are both safe and effective.
Imagine harmonized approval processes and data collection. Such a harmonization would mean medical device companies would have easier access to the right data for intelligent decisionsSM.
-- Vizma Carver, Founder and CEO, Carver Global Health Group