The Advanced Medical Technology Association (AdvaMed) has voiced strong support for new legislation introduced by Sen. Scott Brown (R-Mass.) to streamline the de novo classification process for medical devices.
Brown introduced the bill, S. 1943, the “Novel Device Regulatory Relief Act of 2011,” on Dec. 5. If passed, it would amend section 513 of the Federal Food, Drug and Cosmetic Act to simplify the process medical device makers must go through to request de novo classification.
“This bill saves time and resources by eliminating the requirement that companies submit a 510(k) for technologies and receive a ‘Not Substantially Equivalent’ determination when they know going into the classification that there is no predicate technology,” said AdvaMed president and CEO Stephen J. Ubl in a prepared statement. “Eliminating this unnecessary step will make the process more efficient.”
The de novo review process is a halfway point between expedited 510(k) “substantial equivalence” and full premarket application (PMA). De novo was added to the FD &C Act in 1997 to handle “novel” devices—the ones that lack a substantially equivalent predecessor but pose only low or moderate risk to patients.
Brown’s bill builds on and clarifies language proposed by Rep. Brian Bilbray in October to modify the de novo process, noted Jennifer Newberger, an attorney specializing in medical device law with Hyman, Phelps & McNamara in Washington, D.C. The firm interpreted the language in Bilbray’s bill to “allow the sponsor to submit a de novo petition without submitting a 510(k) notification,” she wrote at FDA Law Blog Dec. 6. “The language proposed by Senator Brown appears to clarify this ambiguity. He adopts the same language proposed by Rep. Bilbray, permitting a sponsor to submit a de novo petition without awaiting a written notification of a Class III determination. He also proposes language stating that any person who is required to submit a 510(k) notification, and determines that there is no applicable predicate device, ‘may submit a request for initial classification of the device’ and may recommend a specific classification to FDA.”
Newberger also commented that device makers “should probably seek input from FDA prior to submitting an initial classification request to determine whether FDA agrees that the de novo approach is appropriate. Given the current inefficiencies associated with the de novo process, this seems like something both parties should be willing to do.”
Ubl was unequivocal in his enthusiasm for Brown’s bill. “We strongly support the need to strengthen and optimize the de novo process through a well-defined regulatory pathway, which will benefit the agency, industry and patients,” he said. “We believe the under-utilized de novo process has the potential to play a key role in the regulation of medical devices.”