Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Parallel Review Pilot for Innovative Devices Launched by FDA and CMS

A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Services (CMS) could expedite the review process for some cutting-edge devices and make Medicare reimbursement requirements more transparent.

The program allows concurrent review of devices by both FDA and CMS staff, minimizing the time between FDA 510(k) clearance or approval and Medicare coverage decisions. Although FDA and Medicare reviews of medical devices are not identical, both agencies use clinical data to inform their decisions.

Devices qualifying for parallel review include:

New technologies that have been granted a pre-investigational device exemption (IDE) or approved IDE application designation
New technologies that would require either a supplemental application for premarket approval or a de novo petition
New technologies falling within Part A or Part B Medicare categories that are not subject to national coverage decisions

The program is slated to last for up to two years, but will accept only three to five submissions per year. Assuming the program’s pilot phase proves successful, the agencies should seriously consider expanding access to the program to a wider variety of medical devices.

Markets: USATags: 510(k), 510k, CMS, de novo, FDA, Medicare

Author: Stewart EisenhartDate: October 7, 2011

FDA Unveils Two-Option De Novo Approach

The US Food and Drug Administration has published draft guidance establishing two pathways for medical device manufacturers filing de novo petitions to reclassify their devices from Class III to Class I or II. Up to now, the FDA has characterized the de novo process as underutilized due to process inefficiencies.

Set up to address “new” devices that the FDA has found not substantially equivalent (NSE) during 510(k) reviews, the de novo process enables a manufacturer or sponsor to request that the agency make a risk-based classification decision on its product. A successful de novo petition results in reclassification of the device from Class III to a lower-risk category.

De Novo applicants must meet two criteria: First, the device in question should not fall within a device type that has already been classified based on risk. Second, the device in question must have already been classified as Class III, with written FDA notice, no more than 30 days prior to the de novo petition.

The first pathway for the de novo process is the pre de novo submission (PDS), designed to provide applicants with early-stage access to regulatory reviewers who analyze whether a device is indeed suitable for the de novo process and recommend information to submit with a de novo petition. The PDS pathway, according to the guidance, will provide applicants with greater predictability and transparency during the de novo process. Submission of a PDS would preclude submission of a 510(k) application and de novo petition.

The second pathway entails a standard 510(k) submission, the method currently in place for de novo applicants. Once a 510(k) submission has resulted in an NSE, the applicant has 30 days to submit a de novo petition for a device.

Markets: USATags: 510(k), 510k, de novo, FDA, medical device

Author: Stewart EisenhartDate: October 3, 2011

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the less controversial components of its planned reform of the 510(k) premarket notification process for moderate-risk medical device clearance.

The more polarizing aspects of the FDA’s plans, including establishing a new Class IIb device category requiring clinical information to support equivalence determinations as well as requiring postmarket surveillance studies as a condition of clearance for some devices, will not be finalized until after an independent report by the Institute of Medicine is issued later this year. Although the details that were announced by the FDA today warrant careful study by device manufacturers in order to comply, the most important elements of the agency’s reform plan remain unknown; manufacturers will have to maintain their wait-and-see (or wait-and-lobby) approach at least until midyear.

What the FDA did disclose regarding its 510(k) reform plans included streamlining of its Class III de novo classification process, clarifying which instances require 510(k) applicants to submit clinical data during their review processes, and establishing a group of FDA experts, the Center Science Council, to develop consistent business processes and standard operating procedures.

Action items covering improvement of clinical trial quality, 510(k) rescission appeals, and development and application of unique product codes will also be implemented by the FDA over the course of 2011. Whether or not the agency will also set up implementation timelines for its more challenging proposals remains unknown.