Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Gray Sheet

Executive Summary

FDA MEDICAL DEVICE 510(k) "NONAPPROVAL" DECISION will stop the "endless loop" of FDA supplemental data requests for deficient 510(k) submissions, FDA Center for Devices and Radiological Health Director Bruce Burlington told executives at a March 30 session of the Health Industry Manufacturers Association annual meeting in Palm Beach, Florida. Burlington said that FDA will deem a 510(k) "nonapprovable" if, after comprehensive review, it "needs a major fix such as product redesign or a major study." In his first public speech, Burlington explained that "in the past, we didn't really have a mechanism to say no on a 510(k) application." About 2% of 510(k)s are "not substantially equivalent" because a premarket approval application should be filed instead, he noted; however, for products that are "still in the 510(k) arena," the agency has not had "a clear mechanism to say...this application is just so poorly worked up...Go back, redo it, and come in with a new 510(k)." In some cases, manufacturers have withdrawn 510(k)s, Burlington noted, but "sometimes [the firm] and we in FDA were just in a closed loop. We ask for...more information, and you really don't understand enough about the process to provide real fixes for the application." He maintained that the nonapproval decision "will be more efficient for us and...more efficient for" industry. "Wouldn't you rather have straight talk from the agency instead of an endless loop of requests for information that really is a 'no' in disguise?" The nonapproval decision is one of a number of steps CDRH is taking "to make the best use of its resources" as it works to "improve predictability and consistency" in device reviews and reduce delays in the review process, Burlington asserted. The CDRH director and outgoing Office of Device Evaluation Acting Director Alan Andersen also told the HIMA execs about resource reallocation plans, as well as other resource-saving initiatives (see stories, p. 3 & 5). Burlington emphasized that the nonapproval decision would apply to 510(k)s that have made it through an initial "filing screen" and have undergone a full-scale review. The agency is planning to set up a filing review system for 510(k)s that will be similar to its existing PMA filing program. "We are going to quit babysitting low-quality applications through the review process," Burlington said. Therefore, at an early stage in application review, FDA will determine if the submission is "administratively complete and if there's a reasonable chance of getting through the process for full evaluation. If not, we intend to return it right away and tell you why." He maintained that "refusing to review applications that have little chance of being approved is critical to using our resources more efficiently." Burlington, a physician who became CDRH director on Feb. 22 after working for several years in FDA's biologics and drug programs, also told the device industry topsiders about his philosophy regarding the need for clinical data in device applications. "Some of you have worried that an MD from the Center for Drugs would expect a 2,000-patient, double-blind, randomized controlled trial for every device...or would edge up to that sort of standard. That's what I've heard called the drugs model." He asserted that CDRH does not intend "to require controlled clinical trials for devices" nor does it "expect 2000-patient double-blind randomized controlled clinical trials for devices." He added that "in fact, clinical trials aren't necessary for most devices. However, when clinical trials are required, FDA is going to demand that they are "good ones -- not necessarily big ones, just good ones. They must be well-designed, ask the right questions," use "good scientific methods" and provide "high- quality data on safety and effectiveness." The recently released report of FDA's Committee for Clinical Review ("the Temple group") concluded that the sponsors of the approval applications it assessed had failed to adequately consider the use of randomized trials ("The Gray Sheet" March 8, p. 1). Burlington told HIMA that he believes that the Temple report "is an important assessment of some...applications, with excellent recommendations." However, he stressed that the findings, which were based on a review of several problematic applications, cannot be "generalized." The study also was done from "a drugs perspective," Burlington noted, adding that "we need to determine what...a device model of product development" is. The device center director said that he has asked Robert Eccleston, special assistant to the director, and Philip Phillips, director of ODE's program operations staff, to conduct a followup "targeted, retrospective review" of a limited number of device applications to see if the problems observed in the Temple report are more widespread.

You may also be interested in...

UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer

With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.

QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals

Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts