Draft Guidance Establishes Accreditation Process for Third-Party Medical Device Reviews

A new draft guidance document from the US Food and Drug Administration (FDA) regarding the accreditation process for firms utilizing its Third Party Review Program (TPRP) aims to establish a regulatory framework that can later be harmonized with one under development by the International Medical Device Regulator's Forum (IMDRF).

Background

In October 2012, IMDRF, a regulators-only medical device harmonization group that succeeded the Global Harmonization Task Force (GHTF), released a draft document detailing its plan for standardizing how it recognizes third-party medical device auditing organizations.

Those organizations are commonly used-though most often outside the US-to ensure that companies' products conform to standards set by local and regional regulators before being allowed on the market. "Auditing activities which are part of conformity assessment activities are intended to provide the objective evidence of safety, performance, and benefits and risks to maintain public confidence," IMDRF explained in the document.

Though not as widely used in the US, which has a more rigorous process for medical device approvals than most regions, third-party reviews nevertheless have been allowed on a voluntary basis in the US for a number of years. Originally authorized under the FDA Modernization Act of 1997, its provisions were recently renewed and expanded under the FDA Safety and Innovation Act of 2012.

A narrow group of devices are permitted to use the TPRP in the US. Namely, only those devices that are Class I (low risk) or non-implantable Class II devices not requiring clinical trials to show proof of safety or efficacy. Class II devices that are intended to be life-supporting or -sustaining are also prohibited, as are all Class III (high-risk) medical devices requiring a premarket approval (PMA) application.

Any company making a device eligible for the program can then opt to have a third-party accredited entity inspect its facilities for compliance with FDA's Quality System Regulations (QSRs). That third party then submits that information to FDA, which has final say on whether the information contained within the inspection report is sufficient to support marketing clearance.

The program, FDA said, is good for all parties involved. Medical device companies can get more timely inspections, allowing them to market their products more quickly. FDA, meanwhile, is able to use its staff resources to review higher-risk devices without sacrificing much in the way of confidence that lower-risk products are still safe for consumer use.

The Program

TPRP submissions are accepted and evaluated using a five-part test, FDA said.  TPR forms must contain:

1. administrative information,
2. a certification/agreement statement signed by the most responsible individual at the firm, including a certification that the firm will at all times while accredited by FDA be in conformity with the IMDRF's document entitled  "Recognition Criteria for Medical Device Auditing Organizations," which includes the International Organization for Standardization (ISO)/the International Electrotechnical Commission (IEC) 17021:2011 requirements as indicated in the IMDRF document
3. a certification of eCopy understanding
4. a certification that the firm has an adequate code of conduct
5. a certification that the firm will ensure competency by meeting general competency requirements for the organization and competency requirements for product assessors or product reviewers

Companies wishing to become accredited under the TPRP must apply through FDA's Center for Devices and Radiological Health (CDRH), and submit information about the name and location of the firm, contact information, a description of the firm, and a listing of any non-FDA accreditations.

In addition, companies must also submit a certification that all information submitted to FDA will be accurate, that work will be limited to areas in which it has "competence and capacity," be in conformity with FDA and IMDRF regulations and requirements, and in compliance with eCopy submission requirements.

Accreditations under the program are good for three years, after which time FDA will need to renew the accreditation in order for the firm to be allowed to continue to operate in the TPRP program. Denials by FDA may be appealed to CDRH's ombudsman.

The draft guidance only describes a portion of the program, and additional guidance is likely forthcoming.

Read the entire draft guidance: Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers