Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
Published . Updated .
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to the current publicly available resources and associated content developed to support IDE electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for sponsors to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
Directly affected
- IDE Voya Infrastructure, Industrials & Materials Fund
Named in this report.
Indirectly affected
- XLV Health Care Select Sector SPDR
Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- XBI SPDR S&P Biotech ETF
SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- LLY Eli Lilly and+12.6% 30d
Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- JNJ Johnson & Johnson-0.2% 30d
Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- PFE Pfizer+8.1% 30d
Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MRK Merck-2.9% 14d
Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
Price reaction, T-5 to T+3
| Ticker | T-5 | T-3 | T-1 | T0 | T+1 | T+2 | T+3 |
|---|---|---|---|---|---|---|---|
| IDENo price data for this ticker | — | — | — | — | — | — | — |
| XLVNo price data for this ticker | — | — | — | — | — | — | — |
| XBINo price data for this ticker | — | — | — | — | — | — | — |
| LLYNo price data for this ticker | — | — | — | — | — | — | — |
| JNJNo price data for this ticker | — | — | — | — | — | — | — |
| PFENo price data for this ticker | — | — | — | — | — | — | — |
| MRKNo price data for this ticker | — | — | — | — | — | — | — |
Closing-price change versus T-1, the last close before the story. T0 to T+3 fill in after each market close. Prices: Alpaca IEX.
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for s…
Source: Federal Register
Trades by members of Congress and officials in the stocks in this story
- Rep. Rohit Khanna bought Eli Lilly (LLY) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 53 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 25 Sep 2026. That is 32 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Lloyd Doggett bought Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 8 Sep 2026. That is 49 days before publication. Filed 5 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 53 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Rohit Khanna sold Pfizer (PFE) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 53 days before publication. Filed 7 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 21 Aug 2026. That is 67 days before publication. Filed 8 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 31 Jul 2026. That is 88 days before publication. Filed 22 Sep 2026. View the filing.
- Rep. Maria Elvira Salazar sold Merck (MRK), worth $1,001 - $15,000 on 24 Sep 2026. That is 33 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar bought Merck (MRK), worth $15,001 - $50,000 on 19 Aug 2026. That is 69 days before publication. Filed 9 Sep 2026. View the filing.
- Donald J Trump, an executive branch official, sold Merck (MRK), worth $250,001 - $500,000 on 31 Jul 2026. That is 88 days before publication. Filed 22 Sep 2026. View the filing.
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
Who gains and who loses around Select Sector Spdr Tr (XLV)
Companies carried with this story
- XLV Select Sector Spdr Tr
In “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” Select Sector Spdr Tr (XLV) is linked, with no stored direction, medium confidence. Reason on file: Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
- XBI Spdr Series Trust
For “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” Spdr Series Trust (XBI) is linked, with no stored direction, medium confidence. Reason on file: SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
- LLY Eli Lilly
For “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” Eli Lilly (LLY) is linked, with no stored direction, medium confidence. Reason on file: Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- JNJ Johnson & Johnson
For “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” Johnson & Johnson (JNJ) is linked, with no stored direction, medium confidence. Reason on file: Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- PFE Pfizer
For “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” Pfizer (PFE) is linked, with no stored direction, medium confidence. Reason on file: Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
- MRK Merck
Merck (MRK) is linked, with no stored direction, medium confidence in the 27 Oct 2026 story “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability.” Reason on file: Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story
Select Sector Spdr Tr (XLV)
Select Sector Spdr Tr (XLV) is the company in “Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability,” the 27 Oct 2026 this story story.
What ties Select Sector Spdr Tr (XLV) to the headline is this: Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
Spdr Series Trust (XBI) is here too. Its reason reads: SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story
The price range for Select Sector Spdr Tr (XLV), and the dates in the story
LLY traded between 1131.55 and 1321.17 across 20 sessions. The latest close on file is 1279.57. XBI traded between 152.63 and 158.97 across 2 sessions. The latest close on file is 154.01. XLV traded between 166.19 and 168.74 across 2 sessions. The latest close on file is 167.68.
How strong the case is around Select Sector Spdr Tr (XLV)
54 out of 100
“Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.