Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Ryan E. Day
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
Taran March @ Quality Digest
From digital submissions to integrated document control, the agency moves into the lean arena
Dirk Dusharme @ Quality Digest
By scaring off small medical-device companies, Canada could limit number of important and innovative products
Mike Richman
For answers to some troubling life-science questions, ask a quality professional
Ryan E. Day
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA

More Features

FDA Compliance News
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live
Awards help states implement multiyear produce-safety systems

More News

Michael Causey

FDA Compliance

FDA’s Local Offices Flex Regulatory Muscle

The agency is holding medical device manufacturers accountable for eMDRs and CAPAs

Published: Wednesday, December 17, 2014 - 16:26


s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very well, either.

“The adequacy of your firm’s response dated Nov. 20, 2013, cannot be determined at this time,” FDA’s warning letter said. “Your firm’s response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.”

Electronic Development Labs makes the NervoScope.

The agency also gently encouraged the company to look into electronic medical device reporting (eMDR).

As AssurX has noted before, the FDA eMDR final rule requiring manufacturers and importers to submit eMDRs to the FDA was published on Feb. 13, 2014. The requirements of this final rule will take effect on Aug. 14, 2015. If a firm is not currently submitting reports electronically, the FDA politely encourages it to look into it on the FDA’s web page devoted to eMDR.

The FDA demonstrated its ongoing interest in corrective and preventive action (CAPA) in an Oct. 7, 2014, letter from its Los Angeles office to Alpha Medical, a maker of angiographic balloon catheters.

After Alpha tried to respond to a September 2014 inspection, the FDA made it clear the reply needed some work. Example: “CAPA 104 was opened on Jan. 10, 2013, concerning nonconformities regarding balloon extension air leaks. The CAPA report references multiple root causes for these leaks; however, not all of these potential causes were analyzed and investigated.

“Your records reference that personnel were retrained, but the corrective actions for which they were retrained were not documented,” the agency went on. “Additionally, this CAPA was closed on Feb. 22, 2013, without documentation that an effectiveness check was performed.”

In an Oct. 10, 2014, letter from the Cincinnati district office, local regulators challenged West Lake Enterprises, maker of medical gas pressure regulators and suction regulators, with CAPA and other violations, including installation that’s not in conformity with the current good manufacturing practice requirements of the quality system regulation. The company responded, and the FDA came back with additional questions.

The Denver district office joined in with an Oct. 28, 2014, letter to Xanacare Technologies, maker of SimulCare II, a therapeutic lamp/nerve stimulator/massager. The agency hit it for several issues, including problematic design control, device history records, and complaint handling. As of late October 2014, the agency said it had not received a response from Xanacare.

First published Nov. 24, 2014, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.