The next step is for companies to

prepare the necessary information about the device for submission, Harmer says. The FDA has developed device-specific guidance documents that describe the information that should be included in the 510(k). She says the typical 510(k) submission process takes between four and six months.

Sounds complicated? It is, says Stuart Goldman, senior consultant, quality assurance/regulatory affairs, for Emergo, a medical device consult- ing firm based in Austin, Texas. “The FDA has the most complex classifica- tion system of any developed country. There are over 6,000 product codes— which help identify the generic cat- egory of a device—and 1,900 regula- tion numbers.” If a company manages to navigate the system and receive 510(k) clear- ance, there are just a few more steps required, he says. “A company will then register their establishment and list their device(s) with the FDA in accor- dance with federal regulations (21 CFR Part 807). In addition, the 510(k) summary for the cleared device will be listed in the FDA’s 510(k) database ( cfdocs/cfpmn/pmn.cfm). Now the com- pany can start legally selling the device.”

Areas of Confusion and Concern Included in the 510(k) required doc- umentation is information on the device’s indication for use, Anderson says. “ASCs have to be very cautious and attuned to how they intend to use a device. ASCs should confirm their use of the device complies with the device’s approved use.” For example, wipes (solutions) specifically designed to sanitize surfaces should not be used to disinfect surfaces. “That may sound like a small issue, but it can raise big safety concerns. Sanitizers reduce but do not kill germs; disinfectants kill germs,” Anderson says. On occasion, a device’s indica- tions for use will change, Harmer says.

No Inspection Requirement

ASCs should know about a “major pitfall” in the 510(k) clearance process, says Stuart Goldman, senior consultant, quality assur- ance/regulatory affairs, for medical device consulting firm Emergo based in Austin, Tex- as. “Not included in the 510(k) submission or clearance process is an FDA inspection of the company’s quality system with respect to how that device is made.”

FDA cleared devices are expected to be made in accordance with the FDA’s quality system regulations (i.e., good manufacturing prac- tices [GMPs]) defined within the FDA’s code of federal regulations (21 CFR Part 820), Gold-

man says. “FDA inspections, when they occur, check for whether companies are in compliance with these GMPs. The FDA says they try to perform these inspections every three years, but that does not always happen.

“There are only so many FDA inspectors to go around,” he continues. “A company can get a device cleared but not be in compliance with all of the GMPs for years before an inspection discovers poor practices. We have found that many small device companies are not even aware of these GMP requirements.”

When a company does not follow GMPs, patient safety might be at risk. Goldman cites one example of a spinal hardware developer that received 510(k) clearance for a device in early 2011. Later that year, the FDA began an inspection that lasted more than a year. During that time, inspectors found several major GMP violations related to how the device was designed and manufactured. The GMP violations were unrelated to how the device was cleared through the FDA’s 510(k) process

As a result of these violations, the FDA issued the company a “warning letter” in early 2012. Warning letters serve as notifications that a manufacturer has violated FDA regulations. They also identify the violations, direct companies to make cor- rections, provide deadlines for implementation of corrections and note plans for a follow-up FDA inspection. In this case, Goldman says, the spinal hardware com- pany continued to operate into 2013 before going bankrupt.

When this occurs, the device will often require new 510(k) clearance. “FDA says a ‘major change or modification’ in the intended use of the device usu- ally requires the submission of a new 510(k),” she says. Submission of a new 510(k) for an

existing device is usually triggered by the addition of, rather than change to, an intended use, Anderson says. Goldman says this rule confuses

some device companies. “You would be surprised how many smaller device companies are not aware of this requirement or do not believe their change is relevant to the requirement.”

ASCs can get tripped up mul-

tiple ways concerning a device’s instructions for use, which are differ- ent from indications for use, Harmer says. 510(k) clearance documentation requires the inclusion of usability stud- ies, which are intended to demonstrate that users can read, understand and fol- low instructions for a device’s use. “ASCs can receive citations from

regulatory bodies and accreditation organizations for failure to properly follow instructions for use,” she says. “It is a company’s responsibility to include instructions for use with its devices and an ASC’s responsibility


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