Earlier this month, President Barack Obama signed new legislation that opens a new fast lane for medical device approval.
Just one of many new reforms affecting device companies, the 21st Century Cures Act will give manufacturers the option of reporting to just one FDA review board, saving the time and resources previously required to get permission from regional review boards near test subjects.
Supplier qualification processes aren't just recommended precautions to guard against compliance issues, they're a regulatory requirement for most FDA-regulated manufacturers.
"Qualifying" a supplier, in this case, should be thought of as a kind of quality system within a quality system.
Candidate suppliers and vendors should be thoroughly evaluated against your own quality requirements, compared with other options, physically evaluated and reevaluated on a regular basis to ensure compliance both now and in the future.
Although most drug and device manufacturers have a supplier qualifciation process in place already, one company's approach can look much different than another's.
We’ve laid out a clear and concise five-step supplier qualification process that can be integrated and expanded upon to meet your organization's unique needs.Continue Reading
For years, FDA-regulated manufacturers have tried to apply a one-size-fits all quality management approach to their entire roster of suppliers.
But with so much variability from one supplier to another, this approach can be woefully inefficient and downright dangerous when lapses in management allow potentially serious compliance issues to develop.
The increasingly popular risk-based approach to managing supplier quality allows manufacturers to craft a malleable quality management system that can be shaped to fit each supplier individually––enabling you expend the greatest effort toward mitigating the risks that pose the most damage.Continue Reading
In the age of outsourcing, drug and device manufacturers depend on their suppliers for critical activities, making them vulnerable to potentially devastating quality issues.
On top of this, many manufacturers continue to operate under the false assumption that by handing over duties to suppliers, so too go the responsibilities for maintaining regulatory compliance. This is not the case.
Although it's in suppliers' interests to keep themselves to a high standard of quality to attract clients, the regulatory burden ultimately rests on the company receiving their products or service.Continue Reading
A newly-finalized guidance leaves no doubt as to what FDA expects to see in quality agreements between drugmakers and contract facilities––the documents used to maintain compliance with current good manufacturing practices (cGMP).
In light of these changes, drugmakers with existing quality agreements should review all existing quality agreements to ensure outsourced suppliers and other contract facilities comply with these requirements.
The guidance – a clarified version of a May 2013 draft – lays out the broader goal of a quality agreement: define manufacturing roles and responsibilities and establish expectations for communication between parties.
In particular, the guidance establishes how contractors will report manufacturing deviations and how those issues will be investigated and resolved in order to maintain cGMP compliance.Continue Reading
In an effort to improve data sharing and cybersecurity in medical devices, three national organizations have signed a new Memorandum of Understanding (MOU) outlining new measures device manufacturers should be aware of.
The National Health Information Sharing and Analysis Center (NH-ISAC), the National Device Innovation, Safety and Security Consortium (MDISS), and the U.S. Food and Drug Administration (FDA) Center for Devices an Radiological Health (CDRH) have each signed off on the new set of goals aimed at mitigating cybersecurity threats.
[Free White Paper:] FDA Trends & Developments in the Medical Device Industry: 2016
We've summarized the four key objectives laid out in the MOU along with general considerations for device companies.Continue Reading