---
kind: "section"
citation: "21 C.F.R. § 814.47"
title: "21"
number: "814.47"
heading: "Temporary suspension of approval of a PMA."
url: "https://uscodex.org/cfr/21/814.47"
---

# §814.47. Temporary suspension of approval of a PMA.

- (a) **Scope.**
  - (1) This section describes the procedures that FDA will follow in exercising its authority under [section 515(e)(3)](/cfr/21/515.md?p=e-3) of the act ([21 U.S.C. 360e(e)(3)](/usc/21/360e.md?p=e-3)). This authority applies to the original PMA, as well as any PMA supplement(s), for a medical device.
  - (2) FDA will issue an order temporarily suspending approval of a PMA if FDA determines that there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death.
- (b) **Regulatory hearing.**
  - (1) If FDA believes that there is a reasonable probability that the continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences or death, FDA may initiate and conduct a regulatory hearing to determine whether to issue an order temporarily suspending approval of the PMA.
  - (2) Any regulatory hearing to determine whether to issue an order temporarily suspending approval of a PMA shall be initiated and conducted by FDA pursuant to [part 16](/cfr/21/part16.md) of this chapter. If FDA believes that immediate action to remove a dangerous device from the market is necessary to protect the public health, the agency may, in accordance with [§ 16.60(h)](/cfr/21/16.60.md?p=h) of this chapter, waive, suspend, or modify any [part 16](/cfr/21/part16.md) procedure pursuant to [§ 10.19](/cfr/21/10.19.md) of this chapter.
  - (3) FDA shall deem the PMA holder's failure to request a hearing within the timeframe specified by FDA in the notice of opportunity for hearing to be a waiver.
- (c) **Temporary suspension order.** If the PMA holder does not request a regulatory hearing or if, after the hearing, and after consideration of the administrative record of the hearing, FDA determines that there is a reasonable probability that the continued distribution of a device under an approved PMA would cause serious, adverse health consequences or death, the agency shall, under the authority of [section 515(e)(3)](/cfr/21/515.md?p=e-3) of the act, issue an order to the PMA holder temporarily suspending approval of the PMA.
- (d) **Permanent withdrawal of approval of the PMA.** If FDA issues an order temporarily suspending approval of a PMA, the agency shall proceed expeditiously, but within 60 days, to hold a hearing on whether to permanently withdraw approval of the PMA in accordance with [section 515(e)(1)](/cfr/21/515.md?p=e-1) of the act and the procedures set out in [§ 814.46](/cfr/21/814.46.md).

## Notes

### Amendments

[61 FR 15190, Apr. 5, 1996]

### Authority

Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.

### Source

Source: 51 FR 26364, July 22, 1986, unless otherwise noted.

### Amendments

[61 FR 15190, Apr. 5, 1996]