The Medical Device Manufactures Association has submitted comments to CMS and the FDA concerning the jointly proposed "parallel review" process for premarket, FDA-regulated medical products, according to a news release from MDMA.
The parallel review proposal calls for establishing a process for overlapping evaluations of such medical devices when the product sponsor and both agencies agree to such parallel review.
CMS and FDA believe this process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs).
According to the news release, MDMA's concerns focused on:
• how the proposal might be harmful to innovative medical device companies by forcing them to participate;
• the importance of reimbursement coding reform in order to minimize the delays between the regulatory and reimbursement process;
• an alternative to NCDs to ensure they are not the only pathway to coverage; and
• the need for strong protections for a company's proprietary data.
Read the MDMA news release about its concerning regarding parallel review.
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