Warning Letters – July 2024

The US Food and Drug Administration released five warning letters and two close-outs last month, including two warning letters to Chinese makers of plastic syringes.

Warning Letters and Closeouts
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Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists medical device-related warning and close-out letters posted online by the US Food and Drug Administration in July...

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J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
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The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

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US FDA Webinar Highlights 506J Expectations Amid Ongoing Supply Chain Vulnerabilities

 
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A recent CDRH Learn module urges medical device manufacturers to report potential shortages early, even outside emergencies, to help prevent disruptions. Recent natural disasters underscore the need for resilient supply chains, and reported shortages may be added to an FDA list.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
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The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.