Medical Equipment Design Blog

Medical Equipment Design

The Medical Equipment Design Blog is the place for conversation and discussion about medical grade materials and products, electrical and electronic equipment, computers, imaging & software, and home healthcare & diagnostics as used in the medical industry. Here, you'll find everything from application ideas, to news and industry trends, to hot topics and cutting edge innovations.

Previous in Blog: Is There a Plastic Preferred over PVC?   Next in Blog: Expectations for the Excise Tax
Close
Close
Close
Rate Comments: Nested

The Parallel Review Paradox

Posted January 23, 2011 7:00 AM

A U.S. federal parallel review proposal calls for overlapping evaluations of medical devices. The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) contend the process will benefit the public interest by reducing time between FDA marketing approval decisions and CMS national coverage determinations. The Medical Device Manufacturers Association counters that the proposal might be harmful to innovative medical device companies by forcing them to participate, and cites the importance of reimbursement coding reform to minimize delays between the regulatory and reimbursement process. What's your perspective on parallel review?

The preceding article is a "sneak peek" from Medical Equipment Design, a newsletter from GlobalSpec. To stay up-to-date and informed on industry trends, products, and technologies, subscribe to Medical Equipment Design today.

Reply

Interested in this topic? By joining CR4 you can "subscribe" to
this discussion and receive notification when new comments are added.
Guru
Hobbies - CNC - New Member Popular Science - Biology - New Member Hobbies - Musician - New Member

Join Date: Dec 2008
Location: Canada
Posts: 3523
Good Answers: 146
#1

Re: The Parallel Review Paradox

01/23/2011 11:48 AM

If the parallel review was expected to bring them faster access to the gravy train, they'd be for it.

From https://www.cms.gov/DeterminationProcess/ : "National coverage determinations (NCDs) are made through an evidence-based process, with opportunities for public participation. In some cases, CMS' own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)."

The problem for industry is obvious. Public input is permitted, and an outside technology assessment might be involved. This could actually uncover inappropriate approvals in the expedited 510 k approval-for-pay system which has just been announced. Clinical data might be requested, for devices that are not really "substantially equivalent" to some already approved device.

The sense of entitlement in this industry association (your link) is amazing. What other industry would imagine they had the right to strike down "Anything that interferes with the autonomy of med-tech companies to choose their own regulatory pathway.." Yikes.

__________________
incus opella
Reply
Reply to Blog Entry

Previous in Blog: Is There a Plastic Preferred over PVC?   Next in Blog: Expectations for the Excise Tax

Advertisement