C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES › Subpart A—General

21 C.F.R. § 814.9

Confidentiality of data and information in a premarket approval application (PMA) file

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(a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814.82, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section and part 20. The confidentiality of information in a color additive petition submitted as part of a PMA is governed by § 71.15.

(b) The existence of a PMA file may not be disclosed by FDA before an approval order is issued to the applicant unless it previously has been publicly disclosed or acknowledged.

(c) If the existence of a PMA file has not been publicly disclosed or acknowledged, data or information in the PMA file are not available for public disclosure.

(d)(1) If the existence of a PMA file has been publicly disclosed or acknowledged before an order approving, or an order denying approval of the PMA is issued, data or information contained in the file are not available for public disclosure before such order issues. FDA may, however, disclose a summary of portions of the safety and effectiveness data before an approval order or an order denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending issue.

(2) Notwithstanding paragraph (d)(1) of this section, FDA will make available to the public upon request the information in the IDE that was required to be filed in Docket Number 95S-0158 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent under § 50.24 of this chapter. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

(e) Upon issuance of an order approving, or an order denying approval of any PMA, FDA will make available to the public the fact of the existence of the PMA and a detailed summary of information submitted to FDA respecting the safety and effectiveness of the device that is the subject of the PMA and that is the basis for the order.

(f) After FDA issues an order approving, or an order denying approval of any PMA, the following data and information in the PMA file are immediately available for public disclosure:

(1) All safety and effectiveness data and information previously disclosed to the public, as such disclosure is defined in § 20.81.

(2) Any protocol for a test or study unless the protocol is shown to constitute trade secret or confidential commercial or financial information under § 20.61.

(3) Any adverse reaction report, product experience report, consumer complaint, and other similar data and information, after deletion of:

(i) Any information that constitutes trade secret or confidential commercial or financial information under § 20.61; and

(ii) Any personnel, medical, and similar information disclosure of which would constitute a clearly unwarranted invasion of personal privacy under § 20.63; provided, however, that except for the information that constitutes trade secret or confidential commercial or financial information under § 20.61, FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

(4) A list of components previously disclosed to the public, as such disclosure is defined in § 20.81.

(5) An assay method or other analytical method, unless it does not serve any regulatory purpose and is shown to fall within the exemption in § 20.61 for trade secret or confidential commercial or financial information.

(6) All correspondence and written summaries of oral discussions relating to the PMA file, in accordance with the provisions of §§ 20.103 and 20.104.

(g) All safety and effectiveness data and other information not previously disclosed to the public are available for public disclosure if any one of the following events occurs and the data and information do not constitute trade secret or confidential commercial or financial information under § 20.61:

(1) The PMA has been abandoned. FDA will consider a PMA abandoned if:

(i)(A) The applicant fails to respond to a request for additional information within 180 days after the date FDA issues the request or

(B) Other circumstances indicate that further work is not being undertaken with respect to it, and

(ii) The applicant fails to communicate with FDA within 7 days after the date on which FDA notifies the applicant that the PMA appears to have been abandoned.

(2) An order denying approval of the PMA has issued, and all legal appeals have been exhausted.

(3) An order withdrawing approval of the PMA has issued, and all legal appeals have been exhausted.

(4) The device has been reclassified.

(5) The device has been found to be substantially equivalent to a class I or class II device.

(6) The PMA is considered voluntarily withdrawn under § 814.44(g).

(h) The following data and information in a PMA file are not available for public disclosure unless they have been previously disclosed to the public, as such disclosure is defined in § 20.81, or they relate to a device for which a PMA has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61:

(1) Manufacturing methods or processes, including quality control procedures.

(2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which are not available for public disclosure under this provision is available for public disclosure.

(3) Quantitative or semiquantitative formulas.

[51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996; 88 FR 45067, July 14, 2023]
Notes of Decisions
Cited in 11 cases (1 in the last 5 years), 1995–2021 · leading case: In Re Medtronic, Inc., Sprint Fidelis Leads, 623 F.3d 1200 (8th Cir. 2010).
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In Re Medtronic, Inc., Sprint Fidelis Leads, 623 F.3d 1200 (8th Cir. 2010). · cites it 2× “…are not available for public disclosure unless that information has been previously disclosed to the public. 21 C.F.R. § 814.9 (h)(1).”
Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010). “See 21 C.F.R. § 814.9 ; Medtronic Leads, 623 F.”
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011). “3d at 1206 (acknowledging the importance of discovery for plaintiffs who seek to plead a parallel claim and lack access to the specific federal requirements in the premarket approval application); 21 C.F.R. § 814.9 (h)(1) (providing that “[manufacturing methods or processes,…”
Charlotte Kennedy & Robert L. Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995). “21 C.F.R. § 814.9 (b). There is no opportunity for public comment or for any public challenge to the information presented to the FDA by the device manufacturer.”
Contratto v. Ethicon, Inc., 227 F.R.D. 304 (N.D. Cal. 2005). “In their moving papers, defendants also relied upon 21 C.F.R. § 814.9 . At the hearing, defendants were unable to explain how this section applied to the documents at issue.”
Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671 (S.D.W. Va 2015). “3d at 558 ; see also 21 C.F.R. § 814.9 . Second, although a plaintiff must plausibly allege a violation of federal requirements, the plaintiff need not go so far as to demonstrate that the FDA has found the manufacturer to be in violation of federal requirements.”
Rowe v. Mentor Worldwide, LLC, 297 F. Supp. 3d 1288 (M.D. Fla. 2018). “3 ; 21 C.F.R. § 814.9 ; 21 C.F.R. § 814.20 ; 21 C.”
Marmol v. St. Jude Med. Ctr., 132 F. Supp. 3d 1359 (M.D. Fla. 2015). “2010) (noting that FDA regulations keep many of the specifications considered in the PMA process confidential and that they are not readily available to the public (citing 21 C.F.R. § 814.9 )). DISCUSSION A. Strict Liability and Negligent Manufacturing Defect (Counts I & II) 1.”
Cline v. Advanced Neuromodulation Sys., Inc., 921 F. Supp. 2d 1374 (N.D. Ga. 2012). “lemental specifications related to Defendant’s manufacture and/or assembly of implantable pulse generators (“IPGs”) including the Eon Mini Model 3788 Spinal Cord Stimulator; (2) any communications between Defendant and the FDA regarding the PMA specifications and supplemental…”
Andrea Irizarry v. Abbott Labs. (3rd Cir. 2020). “See 21 C.F.R. § 814.9 (h)(1) (providing that, absent previous public disclosure or the abandonment of premarket approval, a new device’s required “[m]anufacturing methods or processes, including quality control procedures” are not available for public disclosure).”
Brumfield v. Medtronic, Inc. (S.D.W. Va 2021). “To hold otherwise would risk imposing an impossible pleading standard, given that the PMA and Medtronic’s manufacturing practices may not be available to plaintiffs before discovery.”
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