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  1. Premarket Submissions: Selecting and Preparing the Correct Submission

Division of Standards and Conformity Assessment

Update: September 20, 2024

On September 20, 2024, the FDA issued the following draft guidances:

These guidances include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase.
 
When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020.

On this Page:

Who We Are

The Division of Standards and Conformity Assessment (DSCA) seeks to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework. DSCA is located in the Office of Readiness and Response (ORR) under the Office of Strategic Partnerships and Technology Innovation (OST).

DSCA fosters a collaborative approach to standards development and application by drawing upon expertise from across the product development, conformity assessment and standards communities.

Mission

DSCA supports the FDA's mission by driving the development, recognition, and appropriate use of voluntary consensus standards for medical devices, radiation-emitting products and emerging technologies. Conformity to relevant standards promotes efficiencies and quality in regulatory review. DSCA:

  • Produces and implements clear policies to promote the appropriate use of standards in regulatory processes
  • Anticipates the need for and leads the development of national and international consensus standards
  • Advances initiatives to enhance confidence in conformity assessment activities
  • Fosters innovation and standardization in technologies that facilitate patient access to novel devices
  • Provides leadership in standards quality and utilization through outreach and global harmonization

What is a Voluntary Consensus Standard?

A standard is a '...document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.' (see ISO/IEC Guide 2 'Standardization and related activities - General vocabulary). A voluntary consensus standard is one that is developed or adopted by Standards Development Organizations (SDOs), both domestic and international, according to strict consensus principles. Consensus standards contribute to regulatory quality because consensus-based SDOs must demonstrate adherence to the tenets of transparency, openness to participation by interested stakeholders, balance of representation, and due process, among other principles. For more information about consensus standards and their use in federal agencies, see OMB Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities and ANSI Essential Requirements: Due Process requirements for American National Standards.

What is Conformity Assessment?

Rigorous conformity assessment is an integral part of a strong regulatory framework incorporating the appropriate use of consensus standards. OMB defines conformity assessment as '... a demonstration, whether directly or indirectly, that specified requirements relating to a product, process, system, person, or body are fulfilled. Conformity assessment includes sampling and testing, inspection, supplier's declaration of conformity, certification, and management system assessment and registration. Conformity assessment also includes accreditation of the competence of those activities.'

How Consensus Standards Can Be Used in Premarket Submissions

While manufacturers are encouraged to use FDA-recognized consensus standards in their premarket submissions, conformance is voluntary, unless a standard is 'incorporated by reference' into regulation.

Demonstrating conformity with FDA-recognized standards facilitates the premarket review process—including for any Premarket Notifications (510(k)s), De Novo requests, Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Product Development Protocols (PDP), Humanitarian Device Exemption (HDE) applications, Investigational New Drug (IND) Applications, and Biologics License Applications (BLA) for those devices that are regulated by the Center for Biologics Evaluation and Research (CBER) as biological products under section 351 of the Public Health Service Act. Standards are particularly useful when an FDA-recognized consensus standard exists that serves as a complete performance standard for a specific medical device. Conformity with other more general standards, e.g., device-specific standards that may not encompass all aspects of device performance, can also streamline the premarket review process.

Applicants should clearly indicate their use of standards in premarket submissions by appropriately identifying any referenced standards in their CDRH Premarket Review Submission Cover Sheet (Form FDA 3514). If a manufacturer elects to conform to one or more FDA-recognized consensus standards to satisfy part of a premarket review requirement, the manufacturer may submit a "declaration of conformity" to the standard(s) (221 U.S.C. 360d(c)(1)(B)). For further information, refer to the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance document.

FDA Standards Recognition Process

The FDA Standards Recognition Program evaluates consensus standards for appropriateness for the review of medical device safety and performance. Technical and clinical staff throughout CDRH participate in standards development and evaluation and help DSCA make decisions to formally recognize, all or partially, or not recognize consensus standards. Manufacturers may submit declarations of conformity to FDA-recognized consensus standards, and when used appropriately, may reduce the amount of supporting testing documentation typically needed in a premarket submission.

What is FDA Recognition?

Recognition is the process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA may recognize all, part, or none of a standard established by a national or international SDO. Any interested party may submit a request for recognition to the FDA.

In general, the FDA actively assesses the impact of new consensus standards and revisions of existing standards on the premarket review process and recognizes these standards, as appropriate. As the FDA determines that new or revised standards are appropriate for meeting requirements under the FD&C Act for medical devices, we will update the Recognized Consensus Standards Database on the FDA's website. Once we have decided to recognize a standard, we will issue a recognition number and provide a 'Supplemental Information Sheet' in the database. To formally recognize such standards, we will periodically publish a recognition list in the Federal Register. The FDA usually performs the activity at least twice annually.

The guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff improves the standards recognition process in four ways:

  1. In accordance with the statute, FDA intends to respond to all recognition requests within 60 days;
  2. In accordance with the statute, FDA will publish its justification for recognition and non-recognition decisions;
  3. FDA may, when appropriate, determine a transition period for new, revised or superseded standards; and
  4. Manufacturers will be permitted to use a standard toward a declaration of conformity in a premarket submission when the standard is entered into the FDA Recognized Consensus Standards Database, without waiting for the Modifications to the List of Recognized Standards to be published in the Federal Register.

How to Find FDA Recognized and Non-Recognized Standards

Standards that have been recognized by the FDA (either wholly or in part) are maintained and are searchable in the FDA's Recognized Consensus Standards Database. Standards for which a non-recognition determination has been made are listed in the Non-Recognized Standards Database. A manufacturer may not submit declarations of conformity to a non-recognized (or superseded or withdrawn) standard, though the standard may still be used under the General Use category (see the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance). The historical record of all FDA's recognition determinations (i.e., recognized wholly, in part, or not) is provided on the Federal Register Documents webpage.

For further information on consensus standards, their use, and their recognition, refer to the standards modules provided in CDRH Learn (under the heading "How to Study and Market Your Device").

Submitting a Request for Recognition

A request for recognition of a standard should contain the following information:

  1. Name and electronic or mailing address of the requester
  2. Title of the standard
  3. Any standard reference or designation number and date
  4. Proposed list of devices for which a declaration of conformity should routinely apply
  5. Basis for supporting the recognition request; for example, the scientific, technical, regulatory, or other basis for the request
  6. A brief identification of the testing or performance or other characteristics of the device(s) or process(es) that would be addressed by a declaration of conformity.

Submit one paper copy by mail to the Division of Standards and Conformity Assessment at the address below or electronically to: CDRHStandardsStaff@fda.hhs.gov.

Division of Standards and Conformity Assessment
Office of Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66
Silver Spring, MD 20993-0002

Requests for Recognition

A decision by the FDA to recognize (complete or partial) or not recognize a consensus standard should follow within 60 calendar days from the date the request was received. When such a decision is made, the Agency will issue the decision letter to the submitter by mail using the mailing address provided or electronically using the email address provided. We intend to update the Recognized Consensus Standards Database with our determination and the rationale supporting the decision for complete or partial recognition. For each recognized standard, we will include a Supplemental Information Sheet (SIS). If applicable, the SIS will identify whether a transition period exists for a revised or superseded standard. The standard may, upon its inclusion in the database, be used in declarations of conformity in medical device submissions. We will announce the decision to recognize the standard (completely or partially) in the next notice in the Federal Register.

For more information about non-recognition determinations, please see the section below entitled 'Non-recognized Standards.'

Recognized Consensus Standards Database

Standards recognized by the FDA (either wholly or in part) are maintained and are searchable in the FDA's Recognized Consensus Standards Database.

Non-Recognized Standards

What is a FDA Non-Recognized Standard?

A non-recognized standard is a standard that the FDA has determined does not satisfy or would not be helpful in satisfying a portion of the FD&C Act (which includes the FDA Modernization Act of 1997 (FDAMA) and 21st Century Cures Act of 2016) or regulations.

Reasons for FDA Non-Recognition

A non-recognition decision does not preclude a standard's use under the General Use category (see the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance). However, non-recognition means that the standard generally does not satisfy or would not be helpful in satisfying a requirement under the FD&C Act or the regulations. A non-recognition determination is communicated to the submitter of the request along with an explanation of the technical, scientific, regulatory, or other basis for the decision.  If FDA decides not to recognize a standard, the standard would not receive a recognition number.

List of FDA Non-Recognized Standards

A summary listing of those standards that have received a non-recognition determination, along with the rationales supporting the non-recognitions, can be found in the FDA's Non-Recognized Standards Database.

Accreditation Scheme for Conformity Assessment (ASCA) Program

CDRH has expanded its standards program to include a conformity assessment initiative working with qualified accreditation bodies and testing laboratories. The ASCA Program is intended to improve the device review process by enhancing the FDA’s confidence in documentation from manufacturers’ declarations of conformity. ASCA is authorized under section 514(d) of the FD&C Act in accordance with amendments made to section 514 by the FDA User Fee Reauthorization Act of 2022. The FDA has published three final guidance documents outlining program details.

The voluntary ASCA Program should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes a declaration of conformity to an FDA-recognized consensus standard eligible for inclusion in ASCA. Ultimately, ASCA is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

For more information and for the final guidance documents, please visit the ASCA web page.

Other Division of Standards and Conformity Assessment Activities

International Medical Device Regulators Forum (IMDRF): CDRH is a member of the International Medical Device Regulators Forum. This organization's mission – to converge regulatory processes across international jurisdictions – is advanced by promoting the use of consensus standards globally. IMDRF's initiatives include publishing recommendations on how to write standards that are appropriate for regulatory use and how regulators can contribute effectively to the standards development process.

Participation in Standards Development Organization (SDO) Activities: CDRH is actively engaged in collaborations with national and international consensus SDOs. CDRH staff participate as technical experts and leaders to various committees to ensure that published standards are suitable and useful for regulatory purposes.

Resources

Contact Us

For standards-specific questions, please contact the CDRH Standards Management Staff at: CDRHStandardsStaff@fda.hhs.gov

For ASCA-specific questions, please contact CDRH at: ASCA@fda.hhs.gov

For general regulatory information, please contact the Division of Industry and Consumer Education (DICE) by phone at:(800) 638-2041 or (301) 796-7100 or by email at: DICE@fda.hhs.gov



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