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Expedited Medical Device Review Leads to More Recalls

The United States Food and Drug Administration has provided expedited priority review for certain medical devices since 1994. The move is meant to shorten the lead time it takes for patients to access breakthrough devices. However, new research published in JAMA Internal Medicine seems to draw correlations between shorter review times and increased chances [...]

Expedited Medical Device Review Leads to More Recalls2020-06-15T18:57:45+00:00

Future Recall Cost of COVID-19 on Pharma Manufacturers

As the numbers of cases grow worldwide and the U.S. tops the list, it’s easy to wonder what the future cost of the Covid-19 novel coronavirus will be on the pharmaceutical industry. There are multiple companies rushing to push coronavirus cures, including one from Gilead Sciences that is already in phase 3 trials and [...]

Future Recall Cost of COVID-19 on Pharma Manufacturers2020-06-15T18:58:01+00:00

What Can We Expect from CPSC During the Covid-19 Pandamic?

The Consumer Product Safety Commission (CPSC) is an independent agency the U.S. government uses to promote and regulate safe consumer products. It was created by Congress in 1972 to develop uniform product safety standards and research product-related injury and illness. The agency oversees consumer product recalls, and it has not slowed down one bit [...]

What Can We Expect from CPSC During the Covid-19 Pandamic?2020-06-15T18:58:10+00:00

Recalls During the COVID-19 Pandemic

Running a recall is never easy, but it’s not made any easier by a global novel coronavirus pandemic. Non-essential businesses are locked down across the country. Those that are open and running may be tasked to help in the fight instead of regular business. Ford, for example, is using its manufacturing equipment to turn [...]

Recalls During the COVID-19 Pandemic2020-06-15T18:58:18+00:00

Cosmetic Safety Legislation Threatens to Spur More Recalls

The FDA monitors cosmetics and make-up for safety, BEFORE they hit consumer shelves. In fact, since the business of creating and selling makeup became big business for YouTubers, influencers across the globe jumped on the trend. However, with a flood of imposter makeup palettes appearing for major makeup influencers like Jeffree Star, the U.S. [...]

Cosmetic Safety Legislation Threatens to Spur More Recalls2020-06-15T18:58:27+00:00

Why Product Recalls Cost Medical Device Manufacturers $5,000,000 a Day

Researching and developing a medical breakthrough is easy when you compare it to the process of getting approval from the U.S. Food and Drug Administration. The FDA had a long list of requirements to reach and maintain compliance, and it’s not a cheap or easy process. Failing to do so, however, can cost your [...]

Why Product Recalls Cost Medical Device Manufacturers $5,000,000 a Day2021-07-19T15:52:15+00:00

Cybersecurity Risks: The Future of Medical Device Recalls

In simpler times, the U.S. Food and Drug Administration (FDA) mostly concerned themselves with food and drugs. These days, the proliferation of medical devices means the agency needs a robust technology department that includes both hardware and software. These medical devices, like anything else connected to the internet, come with cybersecurity concerns. HIPAA Journal [...]

Cybersecurity Risks: The Future of Medical Device Recalls2021-07-19T15:59:18+00:00

How to Meet FDA Medical Device Recall Requirements

The last thing you need during a global pandemic is to deal with a medical device recall. Whether a correction or complete removal from the market, a single medical device recall can cost up to $600 million. The U.S. Food and Drug Administration (FDA) has strict guidance on how and when a recall should [...]

How to Meet FDA Medical Device Recall Requirements2020-06-15T18:58:53+00:00

7 KEY REASONS TO DIGITIZE YOUR RECALL MANAGEMENT PROCESS

Good news for retailers - the U.S. Consumer Product Safety Commission (CPSC) reports product recalls are at their lowest level in 16 years, with only 241 recalls. Even better, digital recall response can drastically reduce processing times and resources dedicated to recall management. Digital recall response management involves a dedicated customer relationship management (CRM) [...]

7 KEY REASONS TO DIGITIZE YOUR RECALL MANAGEMENT PROCESS2020-08-30T16:01:16+00:00

How to Properly Conduct Mock Recalls

Each year, recalls cost companies millions of dollars in industries such as pharmaceuticals, food and beverage, cosmetics, medical devices, and more. They’re one of the biggest threats to profitability and associated with lost costs, delayed product delivery, and reduced consumer trust. Nonetheless, many risk management experts believe that more intricate product supply chains and [...]

How to Properly Conduct Mock Recalls2020-03-17T16:17:09+00:00