Medical Devices
Easing 510(k) Process Involves Strategy, Learning About Competition, Meeting Told
SANTA CLARA, Calif.--Regulatory affairs professionals need to be involved early on in a strategy for Food and Drug Administration submissions, including reaching out to marketing to learn what the competition is doing, according to a Jan. 25 speech to a meeting of device industry representatives.
Regulatory professionals need to be bold, said Connie Hoy, vice president of regulatory affairs and compliance for Cutera Inc., a medical light and laser device maker based in Brisbane, Calif.
“You are not a paper pusher. You are not somebody that's a technical writer. You are a key element in your company's success, and you've got to be bold, and you've got to communicate,” Hoy told a meeting of the San Francisco chapter of the Regulatory Affairs Professionals Society.
Being strategic means talking with marketing, engineering, and clinical staff and talking with the executive team. Planning and researching are essential, said Hoy, who adds that writing the 510(k) or premarket notification application is “probably the least important of the functions that you do as the regulatory warrior that you are.”
“The real key to your success and your success with strategy is you have to get involved in the process very, very, very early, at the very beginning,” Hoy said.
Competitive Intelligence.
Work with marketing and ask for competitive analysis of existing products “because they know and I might not know, and oftentimes I'm able to identify the predicate device I want to use in the 510(k) because marketing told me,” Hoy said.
Learning about the competition includes budgeting for at least one of the big industry trade shows, going to sessions and competitors' booths to check out competition, and discovering what will be on the market next year, she said.
Review FDA clearances to understand what competitors are claiming as part of the strategy for the 510(k) process, Hoy said. Read competitors' 510(k) summary on FDA's website,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. If the competitor submits a 510(k) statement, send a written request to the company, which has 30 days to send a redacted copy, she said.
“The heartbeat of your submission is explaining your device. Your second heartbeat is substantial equivalents.”
--Connie Hoy, Cutera vice president
The indications for use, technical specifications, and predicates (i.e., the devices used in determining whether the 510(k) device is substantially equivalent to one on the market) will be included in that summary. Clinical data from the most recently cleared device offer information for the company's regulatory strategy. In making a good selection of a predicate device, “the process is going to be so much easier and I'm going to have a better chance to get my 510(k) cleared,” Hoy said.
Hoy cautioned that any specification listed on a company's website may or may not be the specification actually submitted to FDA.
Learning More About the Process.
On May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were enacted, the 510(k) became the classification process for an individual device coming to market. The law led to classification of 1,700 types of devices and grouped them into medical specialties.
The 510(k) program is the largest premarket program in number of applications at FDA “and is also without a doubt the least understood process by people generically at the agency,” said Heather Rosecrans, senior adviser for regulatory affairs at Greenleaf Health LLC and vice president of regulatory affairs for the Medical Device Manufacturers Association.
“It's just not intuitive,” said Rosecrans, formerly director of 510(k) staff in the Office of Device Evaluation in FDA's Center for Devices and Radiological Health.
Rosecrans encouraged companies to have conversations with FDA about the process or rules.
Hoy said never go to a pre-submission meeting “and say, 'Mr. FDA, what would you like us to do?’ It's not going to be a happy ending.”
Table of Contents.
When compiling the application, submit a table of contents with the 510(k) including a table for the software, Hoy said. Review the refuse-to-accept checklist the agency sends when an application is refused to understand what should be included.
Rosecrans suggested that including the refuse-to-accept checklist with the page number where each item is found will speed things along.
“You cannot put together a 510(k) today without looking at that refuse-to-accept guidelines,” said Craig Coombs, president of Coombs Medical Device Consulting in Alameda, Calif.
“I now include the entire checklist and tell the reviewer exactly where in my submission to find it because otherwise they're struggling to try to find it. And when they're under the gun, when they're rushed, is there a good chance that maybe they'll miss something and give you a refuse to accept? I think there is,” Coombs said.
Side-by-side tables on subject device specifications, predicate device specifications, and an indication whether they are the same or different help the reviewer. And explain why the differences do not matter, Hoy said.
“The heartbeat of your submission is explaining your device. Your second heartbeat is substantial equivalents,” Hoy said.
By Joyce E. Cutler
Copyright 2013, The Bureau of National Affairs, Inc.