Archive for the ‘US Regulatory’ Category

FDA Meeting on 510(k)s and Design Changes: Is a New Policy Coming?

Monday, June 3rd, 2013

From the Consultants Corner Newsletter, June 2013 Are you prepared to submit a new 510(k) for all modifications or design changes you make to a device that previously received 510(k) clearance? If not, you should take note of a forthcoming meeting that will address FDA policies related to manufacturer requirements when ...

What the US Medical Device Tax Means for You

Thursday, March 14th, 2013

From the Consultant’s Corner Newsletter, March/April 2013 Medical device companies active in the US market began 2013 facing more complicated compliance requirements. As of January 1 2013, a new 2.3% Medical Device Excise Tax (MDET) on medical devices sold in the United States has been in effect. Established under the Patient ...

Could US FDA’s Home Use Device Guidance Lead to a Slippery Regulatory Slope?

Wednesday, March 13th, 2013

From the Consultant’s Corner Newsletter, March/April 2013 FDA recently released a new draft guidance document with the goal of providing the agency's current thinking relative to home use devices, whether they are prescription or over-the-counter devices. Although this is a draft guidance and “does not establish legally enforceable responsibilities,” it does ...

Medtech Week Recap: The Need to Encourage Medical Innovations…and Curb Technology Use

Monday, September 12th, 2011

Last week, a blog post on Medtech Pulse discussed a recent article in New England Journal of Medicine about the need for medical device innovations in low- and middle- income markets. While we often think of medical innovations as cutting-edge technology, in these markets it can mean medtech products that ...

Analysis Shows 37% Increase in US FDA 510(k) Review Time During Past Five Years

Tuesday, June 21st, 2011

Guest post from Stewart Eisenhart, Emergo Group Recent analysis of data available on the US FDA website shows that average 510(k) clearance times for medical device manufacturers have increased 37% between January 2006 and May 2010. The study, conducted by medical device regulatory consultancy Emergo Group, found that the number of days ...

US FDA’s 510(k) Under Fire

Tuesday, February 15th, 2011

Is US FDA’s 510(k) process hazardous to your health? Yes, says a five-year study published in the Archives of Internal Medicine, which reports that more than 70% of recalled devices were cleared for market under the protocol. Nonsense, replies US industry association AdvaMed, which points the finger at a deeply ...

US FDA Launches Medical Device and Radiation-Emitting Product Transparency Website

Tuesday, April 20th, 2010

The US Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency website on 19 April as part of the agency's transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions and summaries of data that provide the ...

Cranfield University Offers Course on Medtech Regulation

Thursday, April 8th, 2010

Cranfield University has announced a three-day course next month titled Management of Regulatory Affairs and its Contribution to the Medical Technology Lifecycle. It will provide students with an understanding of the skills required to control regulatory affairs departments and to achieve worldwide compliance and approvals, according to the university. This ...

Permanent Director Appointed at FDA’s CDRH

Friday, January 22nd, 2010

From the Wire: Dr Jeffrey Shuren has been appointed permanent Director of FDA’s Center for Devices and Radiological Health (CDRH). He previously served as Acting Center Director after the resignation of Dan Schulz in August 2009. FDA Commissioner Margaret Hamburg appointed Shuren to the job on a permanent basis on ...

“Meaningful Use” Criteria for Electronic Health Records Published in the United States

Tuesday, January 12th, 2010

The first-draft criteria for the federal funding of electronic health records as part of the United States’ recovery plans have been published, writes Jon Hoeksma in an article posted on the E-Health Europe website. The initial eligibility criteria made public at the end of December by the Centres for Medicare ...

US Medical Device Studies Lack Scientific Rigour, According to Researchers

Thursday, December 31st, 2009

From the Wire: Cardiac pacemakers, stents and other medical devices implanted each year in hundreds of thousands of patients in the United States often are approved by government regulators based on insufficient scientific review, say researchers from the University of California at San Francisco. The US FDA often approves medical ...

New FDA Guidelines on Advertising

Sunday, June 7th, 2009

Proposed new US Food and Drug Administration (FDA) guidelines on advertising were issued on 26 May 2009.  “Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion,” which can be downloaded from FDA’s website, suggests ways to present risk information to consumers and health-care professionals. The guidelines follow ...