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For questions regarding this document contact Anastacia Bilek at 301-796-5588 or at anastacia.bilek@fda.hhs.gov at CDRH or the Office of Communications, Outreach and Development (CBER) at 301-827-1800 or 800-835-4709.

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U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Compliance

Center for Biologics Evaluation and Research

Preface

In accordance with Section 738(a)(2)(B) of the Act, the submissions listed below are not subject to user fees.

  • HDEs and HDE supplements, including HDE supplements that are reported as 30-day notices;
  • any PMA or PMA supplement intended solely for a pediatric population; or
  • PMAs or PMA supplements submitted by a state or federal government entity unless the device involved is to be distributed commercially.

1 An HDE holder must submit supplements in accordance with PMA requirements under 21 CFR 814.39, except that requests for a new indication for use of a HUD must comply with 21 CFR 814.110. 21 CFR 814.108. However, the timeframe for reviewing HDE supplements is 75 days. 21 CFR 814.108 and 814.114. Thus, changes that would require a 135-day supplement for a PMA would require a 75-day supplements for an HDE.

2 All references to Sections 738 in this guidance document refer to Section 738 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 21 U.S.C. 379j.

These devices must comply with 21 CFR 1040.10, Laser products, and 21 CFR 1040.11, Specific purpose laser products.

3 Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device, must be submitted as a PMA supplement. 21 CFR 814.39(a)(6)

4 A 180-day supplement is a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling. 21 U.S.C. 379i(4)(C)

5 A real-time supplement is a supplement to an approved premarket application or premarket report that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. 21 U.S.C. 379i(4)(D)

6 For the purposes of this guidance, existing manufacturing space can include newly constructed space or buildings provided that they are included under a single Firm Establishment Identifier (FEI).

7 For the purposes of this guidance document, a supplier is anyone that is independent from the manufacturer’s quality management system that provides the manufacturer components, materials, or services. This includes a supplier that may be part of the manufacturer’s organization but operates under a separate quality management system. (i.e., this supplier is known as an internal supplier). In other words, if the supplier is not a part of the manufacturer’s internal audit (quality audit) scope, then the supplier is under a separate quality management system and is considered an internal supplier. Internal suppliers are to be controlled in a similar way as external suppliers are controlled and 30-day notices would be needed for changes that would ordinarily be submitted for supplier changes.

8 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm089274.htm

9 A finished device is defined in 21 CFR § 820.3(l) as any device or accessory to any device that is suitable for use or capable of function, whether or not it is packaged, labeled, or sterilized.

10 Devices subject to premarket approval under section 515 of the Act are also subject to periodic report requirements imposed by the PMA approval order (21 CFR 814.82(a), 21 CFR 814.84(b)). FDA typically specifies that a PMA holder submit a report one year from the date of approval of the original PMA and annually thereafter. Therefore, the periodic report is usually referred to as an annual report.

11 21 U.S.C. 360e(d)(6)(A)(i) and 21 CFR § 814.39(f).

12 Section 515(d)(6)(A)(ii) and 738(a)(2)(A)(vi) of the Act.

SOURCE

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